312
Προσάρτηµα A το οποίο αναφέρεται στο Κεφάλαιο 1, σηµείο 2 του Παραρτήµατος ΧΙ (*) Κατάλογοι που παρασχέθηκαν από τη Μάλτα, σε µία γλώσσα, µε φαρµακευτικά προϊόντα για τα οποία άδεια κυκλοφορίας εκδοθείσα βάσει της µαλτέζικης νοµοθεσίας πριν από την ηµεροµηνία προσχώρησης θα ισχύει έως ότου ανανεωθεί σύµφωνα µε το κεκτηµένο ή µέχρι τις 31 ∆εκεµβρίου 2006, εφόσον η ηµεροµηνία αυτή προηγηθεί. Η αναφορά φαρµακευτικού προϊόντος στον παρόντα κατάλογο δεν προεξοφλεί ότι το εν λόγω προϊόν έχει ή δεν έχει άδεια κυκλοφορίας σύµφωνα µε το κεκτηµένο. ΚΑΤΑΛΟΓΟΣ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ ΠΡΟΣ ΕΙΣΑΓΩΓΗ ΣΤΗ ΡΥΘΜΙΣΗ ΠΟΥ ΣΥΜΦΩΝΗΘΗΚΕ ΣΤΟ ΠΛΑΙΣΙΟ ΤΟΥ ΚΕΦΑΛΑΙΟΥ 1 Trade Name Dosage Form Dose MA Holder Country 0.45% SODIUM CHLORIDE IN 5% GLUCOSE INFUSION SOLUTION N/A B.BRAUN MELSUNGEN AG GERMANY 0.45% SODIUM CHLORIDE INJECTION USP SOLUTION FOR INJECTION 0.45% ABBOTT LABORATORIES UNITED STATES OF AMERICA 0.45% SODIUM CHLORIDE INJECTION, USP SOLUTION FOR IV INJECTION 4.5MG/ML ABBOTT LABORATORIES UNITED STATES OF AMERICA 0.9% SOD. CHLORIDE AND 5% GLUCOSE SOLUTION FOR INJECTION N/A BAXTER HEALTHCARE LIMITED UNITED KINGDOM 0.9% SODIUM CHLORIDE AND 5% GLUCOSE IV INF INFUSION SOLUTION N/A B.BRAUN MELSUNGEN AG GERMANY 0.9% SODIUM CHLORIDE INJECTION SOLUTION FOR INJ 9MG/ML ABBOTT LABORATORIES UNITED STATES OF AMERICA 0.9% SODIUM CHLORIDE INJECTION USP SOLUTION FOR INJECTION 0.9% ABBOTT LABORATORIES UNITED STATES OF AMERICA 0.9% SODIUM CHLORIDE INJECTION USP SOLUTION FOR INJECTION 0.9% ABBOTT LABORATORIES UNITED STATES OF AMERICA 0.9% SODIUM CHLORIDE IRRIGATION SOLUTION FOR IRRIGATION 9MG/ML ABBOTT LABORATORIES UNITED STATES OF AMERICA 0.9% SODIUM CHLORIDE IRRIGATION USP SOLUTION FOR IRRIGATION 0.9% ABBOTT LABORATORIES UNITED STATES OF AMERICA 0.9% W/V SODIUM CHLORIDE INJECTION BP SOLUTION FOR INJECTION 0.9% W/V B.BRAUN MELSUNGEN AG GERMANY 0.9% W/V SODIUM CHLORIDE IRRIGATION SOL. IRRIGATION SOLUTION 0.9% W/V B.BRAUN MELSUNGEN AG GERMANY 0.9% W/V SODIUM CHLORIDE IV INFUSION BP INFUSION SOLUTION 0.9% W/V B.BRAUN MELSUNGEN AG GERMANY 1% W/V LIDOCAINE INJECTION INJECTION SOLUTION 1% W/V B.BRAUN MELSUNGEN AG GERMANY 1.5% GLYCINE IRRIGATION SOLUTION USP IRRIGATION SOLUTION 15MG/ML ABBOTT LABORATORIES UNITED STATES OF AMERICA 1.5% GLYCINE IRRIGATION USP SOLUTION FOR IRRIGATION 15MG/ML ABBOTT LABORATORIES UNITED STATES OF AMERICA 1.5% W/V GLYCINE IRRIGATION SOL. BP IRRIGATION SOLUTION 1.5% W/V B.BRAUN MELSUNGEN AG GERMANY 1/2 STRENGTH CMPD. SODIUM LACTATE + GLUC SOLUTION FOR INJECTION N/A BAXTER HEALTHCARE LIMITED UNITED KINGDOM EL 450 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003 (*) Για το κείµενο του παραρτήµατος XI, βλέπε την ΕΕ L 236 της 23.9.2003, σ. 859.

450 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

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Προσάρτηµα A

το οποίο αναφέρεται στο Κεφάλαιο 1, σηµείο 2 του Παραρτήµατος ΧΙ (*)

Κατάλογοι που παρασχέθηκαν από τη Μάλτα, σε µία γλώσσα, µε φαρµακευτικά προϊόντα για τα οποία άδεια κυκλοφορίαςεκδοθείσα βάσει της µαλτέζικης νοµοθεσίας πριν από την ηµεροµηνία προσχώρησης θα ισχύει έως ότου ανανεωθεί σύµφωνα µετο κεκτηµένο ή µέχρι τις 31 ∆εκεµβρίου 2006, εφόσον η ηµεροµηνία αυτή προηγηθεί.

Η αναφορά φαρµακευτικού προϊόντος στον παρόντα κατάλογο δεν προεξοφλεί ότι το εν λόγω προϊόν έχει ή δεν έχει άδειακυκλοφορίας σύµφωνα µε το κεκτηµένο.

ΚΑΤΑΛΟΓΟΣ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ ΠΡΟΣ ΕΙΣΑΓΩΓΗ ΣΤΗ ΡΥΘΜΙΣΗ ΠΟΥ ΣΥΜΦΩΝΗΘΗΚΕ ΣΤΟΠΛΑΙΣΙΟ ΤΟΥ ΚΕΦΑΛΑΙΟΥ 1

Trade Name Dosage Form Dose MA Holder Country

0.45% SODIUM CHLORIDE IN 5%GLUCOSE

INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

0.45% SODIUM CHLORIDEINJECTION USP

SOLUTION FORINJECTION

0.45% ABBOTT LABORATORIES UNITED STATES OFAMERICA

0.45% SODIUM CHLORIDEINJECTION, USP

SOLUTION FOR IVINJECTION

4.5MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

0.9% SOD. CHLORIDE AND 5%GLUCOSE

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

0.9% SODIUM CHLORIDE AND 5%GLUCOSE IV INF

INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

0.9% SODIUM CHLORIDEINJECTION

SOLUTION FOR INJ 9MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

0.9% SODIUM CHLORIDEINJECTION USP

SOLUTION FORINJECTION

0.9% ABBOTT LABORATORIES UNITED STATES OFAMERICA

0.9% SODIUM CHLORIDEINJECTION USP

SOLUTION FORINJECTION

0.9% ABBOTT LABORATORIES UNITED STATES OFAMERICA

0.9% SODIUM CHLORIDEIRRIGATION

SOLUTION FORIRRIGATION

9MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

0.9% SODIUM CHLORIDEIRRIGATION USP

SOLUTION FORIRRIGATION

0.9% ABBOTT LABORATORIES UNITED STATES OFAMERICA

0.9% W/V SODIUM CHLORIDEINJECTION BP

SOLUTION FORINJECTION

0.9% W/V B.BRAUN MELSUNGENAG

GERMANY

0.9% W/V SODIUM CHLORIDEIRRIGATION SOL.

IRRIGATION SOLUTION 0.9% W/V B.BRAUN MELSUNGENAG

GERMANY

0.9% W/V SODIUM CHLORIDE IVINFUSION BP

INFUSION SOLUTION 0.9% W/V B.BRAUN MELSUNGENAG

GERMANY

1% W/V LIDOCAINE INJECTION INJECTION SOLUTION 1% W/V B.BRAUN MELSUNGENAG

GERMANY

1.5% GLYCINE IRRIGATIONSOLUTION USP

IRRIGATION SOLUTION 15MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

1.5% GLYCINE IRRIGATION USP SOLUTION FORIRRIGATION

15MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

1.5% W/V GLYCINE IRRIGATIONSOL. BP

IRRIGATION SOLUTION 1.5% W/V B.BRAUN MELSUNGENAG

GERMANY

1/2 STRENGTH CMPD. SODIUMLACTATE + GLUC

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

EL450 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

(*) Για το κείµενο του παραρτήµατος XI, βλέπε την ΕΕ L 236 της 23.9.2003, σ. 859.

Trade Name Dosage Form Dose MA Holder Country

10% CALCIUM CHLORIDE SOLUTION FORINJECTION

100MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

10% CALCIUM CHLORIDEINJECTION USP (ABBOJECTINJECTION)

SOLUTION FORINJECTION

100MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

10% DEXTROSE AND 0.225%SODIUM CHLORIDE US

SOLUTION FORINJECTION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

10% DEXTROSE AND 0.225%SODIUM CHLORIDE INJECTIONUSP

SOLUTION FORINJECTION

NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

10% DEXTROSE INJECTION USP SOLUTION FORINJECTION

100MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

10% DEXTROSE INJECTION USP SOLUTION FORINJECTION

10% ABBOTT LABORATORIES UNITED STATES OFAMERICA

10% MANNITOL I.V. INJECTION SOLUTION FORINJECTION

100MG/ML ABBOTT LABORATORIESLTD.

UNITED STATES OFAMERICA

10% MANNITOL IV INJECTION SOLUTION FORINJECTION

10% ABBOTT LABORATORIES UNITED STATES OFAMERICA

10% MANNITOL IV INJECTIONUSP

SOLUTION FORINJECTION

10% ABBOTT LABORATORIES UNITED STATES OFAMERICA

10% W/V CALCIUM GLUCONATEINJECTION BP

INJECTION SOLUTION 10% W/V B.BRAUN MELSUNGENAG

GERMANY

10% W/V GLUCOSEINTRAVENOUS INFUSION BP

INFUSION SOLUTION 10% W/V B.BRAUN MELSUNGENAG

GERMANY

10%DEXTROSE AND 0.225%SODIUM CHLORIDE INJ

SOLUTION FOR IVINJECTION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

1G VENA N I.V. 2.5G/50ML SOL FOR I.V INF 2.5G/50ML KEDRION S.P.A. ITALY

1G VENA N I.V SOL FOR IV INF 10G/200ML KEDRION S.P.A. ITALY

1G VENA N I.V. 1G/20ML SOL FOR IV INF 1G/20ML KEDRION S.P.A. ITALY

1G VENA N I.V. 5G/100ML SOL FOR IV INF 5G/100ML KEDRION S.P.A. ITALY

2% LIDOCAINE HCL INJECTIONUSP

SOLUTION FORINJECTION

20MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

2% W/V LIDOCAINE INJECTION INJECTION SOLUTION 2% W/V B.BRAUN MELSUNGENAG

GERMANY

20% DEXTROSE INJECTION USP SOLUTION FORINJECTION

20% ABBOTT LABORATORIES UNITED STATES OFAMERICA

20% DEXTROSE INJECTION, USP SOLUTION FOR IVINJECTION

200MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

20% MANNITOL IV INJECTION SOLUTION FORINJECTION

200MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

20% MANNITOL IV INJECTIONUSP

SOLUTION FORINJECTION

20% ABBOTT LABORATORIES UNITED STATES OFAMERICA

20% W/V CALCIUM GLUCONATEINJECTION BP

SOLUTION FORINJECTION

20% W/V B.BRAUN MELSUNGENAG

GERMANY

20% W/V GLUCOSEINTRAVENOUS SOLUTION BP

INFUSION SOLUTION 20% W/V B.BRAUN MELSUNGENAG

GERMANY

30% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 30% W/V B.BRAUN MELSUNGENAG

GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 451

Trade Name Dosage Form Dose MA Holder Country

37.5%W/V GLUCOSE WITHELECTROLYTES IVI

INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

3-CIF POWDER FOR INJECTION 1000MG ELSAAD PHARMA SYRIA

4.2% W/V SODIUM BICARBONATEIVI BP

INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

40% W/V GLUCOSE INJECTION BP INFUSION SOLUTIONCONCENT

40% W/V B.BRAUN MELSUNGENAG

GERMANY

40% W/V GLUCOSEINTRAVENOUS INFUSION BP

INFUSION SOLUTION 40% W/V B.BRAUN MELSUNGENAG

GERMANY

5% DEXTROSE AND 0.225% NACLINJECTION

SOLUTION FORINJECTION

NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

5% DEXTROSE AND 0.225%SODIUM CHLORIDE INJ

SOLUTION FORINJECTION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

5% DEXTROSE AND 0.45% NACLINJ.

SOLUTION FORINJECTION

NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

5% DEXTROSE AND 0.45%SODIUM CHLORIDE INJ

SOLUTION FOR IV INJ N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

5% DEXTROSE AND 0.9% NACLINJ.

SOLUTION FORINJECTION

NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

5% DEXTROSE AND 0.9% SODIUMCHLORIDE INJ

SOLUTION FOR IV INJ N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

5% DEXTROSE AND LACTATEDRINGER'S INJ USP

SOLUTION FOR IVINFUSION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

5% DEXTROSE INJECTION USP SOLUTION FORINJECTION

5% ABBOTT LABORATORIES UNITED STATES OFAMERICA

5% DEXTROSE INJECTION, USP SOLUTION FORINJECTION

50MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

5% W/V GLUCOSE INJECTION BP SOLUTION FORINJECTION

5% W/V B.BRAUN MELSUNGENAG

GERMANY

5% W/V GLUCOSE INTRAVENOUSINFUSION BP

INFUSION SOLUTION 5% W/V B.BRAUN MELSUNGENAG

GERMANY

5.85% W/V SODIUM CHLORIDEINJECTION BP

SOLUTION FORINJECTION

5.85% W/V B.BRAUN MELSUNGENAG

GERMANY

50% DEXTROSE INJECTION USP SOLUTION FORINJECTION

50% W/V ABBOTT LABORATORIES UNITED STATES OFAMERICA

50% DEXTROSE INJECTION USP SOLUTION FORINJECTION

50% ABBOTT LABORATORIES UNITED STATES OFAMERICA

50% DEXTROSE INJECTION, USP SOLUTION FORINJECTION

500MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

50% MAGNESIUM SULFATEINJECTION

SOLUTION FOR IV/IM INJ 500MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

50% MAGNESIUM SULFATEINJECTION, USP

SOLUTION FORINJECTION

4 MEQ MG++/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

50% MAGNESIUM SULPHATE INJUSP

SOLUTION FORINJECTION

50% ABBOTT LABORATORIES UNITED STATES OFAMERICA

50% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 50% W/V B.BRAUN MELSUNGEN AG GERMANY

50% W/V GLUCOSE INJECTION BP INFUSION SOLUTIONCONCENT

50% W/V B.BRAUN MELSUNGEN AG GERMANY

EL452 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

7.45% W/V POTASSIUMCHLORIDE INJECTION

SOLUTION FORINJECTION

7.45% W/V B.BRAUN MELSUNGENAG

GERMANY

70% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 70% W/V B.BRAUN MELSUNGENAG

GERMANY

8.4% SODIUM BICARBONATE INJUSP

SOLUTION F/INJECTION 84MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

8.4% SODIUM BICARBONATE INJUSP

SOLUTION FORINJECTION

8.4% ABBOTT LABORATORIES UNITED STATES OFAMERICA

8.4% SODIUM BICARBONATEINJECTION,USP

SOLUTION FOR IVINJECTION

84MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

8.4% W/V SODIUM BICARBONATEINJECTION BP

INFUSION SOL.CONCENTRATE

8.4% W/V B.BRAUN MELSUNGENAG

GERMANY

8.4%W/V SODIUM BICARBONATEIV INFUSION

INFUSION SOLUTION 8.4% W/V B.BRAUN MELSUNGENAG

GERMANY

AAA MOUTH AND THROATSPRAY

OROMUCOSAL SPRAY 1.5MG/SP MANX PHARMA LIMITED UNITED KINGDOM

AB-ACICLOVIR 250 POWDER FOR INJECTION 250MG/VIAL ASTRAPIN PHARMAGMBH & CO. KG

GERMANY

AB-DICLOFENAC 75 SOLUTION FORINJECTION

75MG/3ML ASTRAPIN PHARMAGMBH & CO.KG

GERMANY

ABDINE COLD RELIEF POWDER POWDER FOR ORALSOLUTION

650MG BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

AB-ERYTHROMYCIN 1000 POWDER FOR INJECTION 1000MG ASTRAPIN PHARMAGMBH & CO.KG

GERMANY

AB-HYDROCORTISONE 100 POWDER FOR INJECTION 100MG ASTRAPIN PHARMAGMBH & CO. KG

GERMANY

ABIDEC DROPS ORAL SOLUTION N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

ABIDEC DROPS ORAL SOLUTION N/A PFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

AB-METHYLPREDNISOLONEACETATE 40

SUSPENSION FORINJECTION

40MG/ML ASTRAPIN PHARMAGMBH & CO. KG

GERMANY

AB-METOCLOPRAMIDE HCL 10 SOLUTION FORINJECTION

10MG/2ML ASTRAPIN PHARMAGMBH & CO. KG

GERMANY

ABSINT 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

ABSINT 2MG CAPSULE 2MG MEDOCHEMIE LTD CYPRUS

ACCOLATE FILM COATED TABLETS 20MG ZENECA LIMITED UNITED KINGDOM

ACCOLATE FILM COATED TABLETS 40MG ZENECA LIMITED UNITED KINGDOM

ACCOLATE COATED TABLETS 20MG ZENECA LIMITED UNITED KINGDOM

ACESAL TABLETS 300MG GEYMONAT SPA ITALY

ACETAZOLAMIDE 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

ACETAZOLAMIDE BP 250MGTABLETS

TABLETS 250MG REMEDICA LTD CYPRUS

ACETAZONE FORTE TAB TABLET N/A TECHNILAB INC. CANADA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 453

Trade Name Dosage Form Dose MA Holder Country

ACETOAMINOPHEN (ACAMOL)TABLETS

TABLET 500MG TEVA PHARMACEUTICALINDUSTRIES LTD

ISRAEL

ACETYSALICYLIC ACID (ASPIRIN)300MG

TABLETS 300MG PHARMAMED LTD. MALTA

ACIC CREME FUR LIPPENHERPES CREAM 50MG/G HEXAL AG GERMANY

ACICLOSTAD CREAM 50MG/1G STADAPHARM GMBH GERMANY

ACICLOSTAD 200 TABLET 200MG STADAPHARM GMBH GERMANY

ACICLOSTAD 800 TABLET 800MG STADAPHARM GERMANY

ACICLOVIR 800MG DISPERSIBLETABLETS BP

TABLET 800MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

ACICLOVIR TABLETS BP 200MG TABLET 200MG SANOFI WINTHROP LTD UNITED KINGDOM

ACICLOVIR TABLETS BP 200MG TABLET 200MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

ACICLOVIR TABLETS BP 400MG TABLET 400MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

ACICLOVIR TABLETS BP 800MG TABLET 800MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

ACIVIR EYE OINTMENT NA CIPLA LIMITED INDIA

ACNE AID SOAP SOAP 6.38% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

ACQUA PER PREPARAZIONIINIETTABILI

SOLUTION FORINJECTION

NA INDUSTRIAFARMACEUTICAGALENICA SENESE S.R.L.

ITALY

ACRICEPT 5MG COATED TABLET 5MG EISAI LIMITED UNITED KINGDOM

ACTAL TABLETS 360MG SEVEN SEAS LIMITED T/AMERCK CONSUMERHEALTH

UNITED KINGDOM

ACT-HIB, VACCIN HAEMOPHILUSTYPE B CONJU

SOLUTION FOR I.M. & S.C.

N/A PASTEUR MERIEUXSERUMS ET VACCINS

FRANCE

ACTIFED DM LINCTUS ORAL SOLUTION N/A GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ACTIFED EXPECTORANT ORAL SOLUTION N/A GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ACTIFED SYRUP SYRUP N/A GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ACTIFED TABLETS TABLETS N/A GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ACTIFED TABLETS TABLETS N/A GLAXOSMITHKLINE SA BELGIUM

ACTIFED TABLETS TABLETS NA GLAXO WELLCOMEBELGIUM S.A.

BELGIUM

ACTILYSE VIALS 50MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

ACTIVELLE -28 TABLETS TABLET NA NOVO NORDISK A/S DENMARK

ACTONEL FILM-COATED TABLETS 5MG GRUPPO LEPETIT SPA ITALY

ACTONEL FILM-COATED TABLETS 30MG GRUPPO LEPETIT SPA ITALY

EL454 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ACTONORM GEL ORAL SUSPENSION N/A WALLACEMANUFACTURINGCHEMISTS LIMITED

UNITED KINGDOM

ACTOS TABLETS 15MG TAKEDA EUROPE R&DCENTRE LIMITED

UNITED KINGDOM

ACTOS TABLETS 30MG TAKEDA EUROPE R&DCENTRE LIMITED

UNITED KINGDOM

ACTRAPID HM 1001U/ML1OMLVIAL

SOLUTION FORINJECTION

1001UML10MLVIAL NOVO NORDISK DENMARK

ACTRAPID HM PENFILL SOLUTION FORINJECTION

100IU/ML NOVO NORDISK A/S DENMARK

ACULAR (KETOROLACTROMETHAMINE) 0.5%

EYE DROPS, SOLUTION 0.5% W/V ALLERGANPHARMACEUTICALS(IRELAND) LTD., INC.

IRELAND

ACUPAN TABLETS COATED TABLET 30MG 3M HEALTH CARELIMITED

UNITED KINGDOM

ACYCLOVIR DENK 200 TABLETS 200MG E.DENK OHG GERMANY

ACYCLOVIR DENK 400 TABLETS 400MG E.DENK OHG GERMANY

ACYCLOVIR DENK 5% CREAM CREAM 5% E.DENK OHG GERMANY

ACYPRONT EFFERVESCENT TABLETS 200MG HEINRICH MACK NACHF.GMBH & CO. KG

GERMANY

ADALAT CAPSULE 10MG BAYER PAKISTAN

ADALAT CAPSULE 10MG BAYER PAKISTAN

ADALAT 10 CAPSULE 10MG BAYER VITAL GMBH &CO. KG

GERMANY

ADALAT LA 30MG RETARD TABLET 33MG BAYER AG GERMANY

ADALAT LA 30MG TABLETS MODIFIED RELEASETABLET

30MG BAYER PLC UNITED KINGDOM

ADALAT LA 60MG RETARD TABLET 66MG BAYER AG GERMANY

ADALAT LA 60MG TABLET MODIFIED RELEASETABLET

60MG BAYER PLC UNITED KINGDOM

ADALAT RETARD RETARD TABLET 20MG BAYER VITAL GMBH &CO. KG

GERMANY

ADALAT RETARD TABLET 20MG BAYER PAKISTAN

ADALAT RETARD LACQUER COATEDTABLET

20MG BAYER PAKISTAN

ADALAT RETARD 10MG COATED TABLET 10MG BAYER PLC UNITED KINGDOM

ADCO-AMOXYCILLIN 250MG/5ML SUSPENSION 250MG/5ML ADCOCK INGRAM LTD SOUTH AFRICA

ADCO-AMOXYCILLIN 500MG CAPSULES 500MG ADCOCK INGRAM LTD SOUTH AFRICA

ADCO-LOPERAMIDE TABLET 2MG ADCOCK INGRAM LTD SOUTH AFRICA

ADD-ACTEN TABLET N/A MEDOCHEMIE LTD CYPRUS

ADDITIVA VITAMIN C PINKGRAPEFRUIT

EFFERVESCENT TABLET 1000MG KRUGER GMBH & CO. KG GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 455

Trade Name Dosage Form Dose MA Holder Country

ADDITRACE CONCENTRATE FORINFUSION

N/A FRESENIUS KABI LIMITED UNITED KINGDOM

ADDITRACE, CONCENTRATE FORINFUSION

CONCENTRATE FORINFUSION

N/A FRESENIUS KABI LIMITED-UK

UNITED KINGDOM

ADENOCOR INJECTION 3MG/ML SOLUTION FORINJECTION

3MG/ML SANOFI WINTHROPLIMITED

UNITED KINGDOM

ADIOS COATED TABLETS NA BROME AND SCHIMMERLIMITED T/A DIOMEDHERBALS

UNITED KINGDOM

ADIZEM-XL CAPSULES 120MG MODIFIED RELEASECAPSULE

120MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

ADIZEM-XL CAPSULES 180MG MODIFIED RELEASECAPSULE

180MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

ADIZEM-XL CAPSULES 240MG MODIFIED RELEASECAPSULE

240MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

ADIZEM-XL CAPSULES 300MG MODIFIED RELEASECAPSULE

300MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

AD-MUC OINTMENT N/A MERZ+CO. GMBH & CO. GERMANY

ADRENALINE AGUETTANT INJECTABLE SOLUTION 1MG/1ML LABORATOIREAGUETTANT

FRANCE

ADRENALINE INJECTION BP1/1000

SOLUTION FORINJECTION

1MG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

ADRENALINE INJECTION BP1/1000

SOLUTION FORINJECTION

1.0MG/ML ANTIGENPHARMACEUTICALS

IRELAND

ADRENALINE INJECTION/DEMO SOLUTION FORINJECTION

1MG/1ML DEMO ABEE GREECE

ADRENALINE TARTRATEINJECTION BP

SOLUTION FORINJECTION

1 IN 1000 EVANS MEDICAL LIMITED UNITED KINGDOM

ADRIBLASTINA POWDER FOR INJECTION 10MG/VIAL PHARMACIA & UPJOHNS.P.A.

ITALY

ADRIBLASTINA POWDER FOR SOLN FORINJECTION

50MG PHARMACIA ITALIA S.P.A ITALY

ADRIBLASTINA SOLUTION FORINJECTION

10MG/5ML PHARMACIA ITALIA S.P.A ITALY

ADRIBLASTINA SOLUTION FORINJECTION

50MG/25ML PHARMACIA ITALIA S.P.A ITALY

ADRIBLASTINA POWDER AND SOLVENTFOR IV INJ.

10MG/5ML PHARMACIA ITALIA S.P.A ITALY

ADRIBLASTINA RTU SOLUTION FORINJECTION

10MG/5ML PHARMACIA & UPJOHNS.P.A.

ITALY

ADRIBLASTINA RD SOLUTION FORINJECTION

50MG/25ML PHARMACIA & UPJOHNS.P.A.

ITALY

ADRIBLASTINA RTU POWDER FOR INJECTION 50MG/VIAL PHARMACIA & UPJOHNS.P.A.

ITALY

ADULT DIFTAVAX INJECTABLE SUSPENSION N/A PASTEUR MERIEUX FRANCE

ADULT MELTUS DRY TICKLYCOUGHS/CATARRH

ORAL SOLUTION N/A CUPAL LTD UNITED KINGDOM

EL456 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ADULT MELTUS CHESTY COUGHW/DECONGESTANT

ORAL SOLUTION N/A CUPAL LTD UNITED KINGDOM

ADULT MELTUS CHESTY COUGHWITH DECONGEST

ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM

ADULT MELTUS FOR CHESTYCOUGHS AND CATARRH

ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM

ADULT MELTUS FOR DRY TICKLYCOUGHS AND CAT

ORAL LIQUID N/A CUPAL LIMITED UNITED KINGDOM

ADULT MELTUS NIGHT TIME SYRUP N/A CUPAL LIMITED UNITED KINGDOM

ADVANTAN FATTY OINTMENT 1MG/G SCHERING AG ITALY

ADVANTAN CREAM 1MG/G SCHERING AG ITALY

ADVANTAN OINTMENT 1MG/G SCHERING AG ITALY

ADVANTAN OINTMENT 0.1% W/W SCHERING SPA ITALY

ADVANTAN FATTY OINTMENT 0.1% W/W SCHERING SPA ITALY

ADVANTAN CREAM 0.1% W/W SCHERING SPA ITALY

ADVIL TABLETS 200MG WHITEHALLINTERNATIONAL INC.

CANADA

ADVIL COLD AND SINUS CAPLETS TABLET N/A WHITEHALL-ROBINS INC. CANADA

ADVIL IBUPROFEN TAB 200MG TABLETS 200MG WHITEHALL-ROBINS INC. CANADA

A-E-MULSIN FORTE EMULSION N/A MUCOS PHARMA GMBH& CO.

GERMANY

AERANNE LIQUID FORINHALATION

100% V/V PHARMACIALABORATORIES LIMITED

UNITED KINGDOM

AERIUS FILM-COATED TABLETS 5MG SCHERING-PLOUGHS.P.A.

UNITED KINGDOM

AERIUS FILM-COATED TABLETS 5MG SCHERING-PLOUGHS.P.A.

ITALY

AEROCROM INHALER MET. DOSE PRESS.AEROSOL

N/A FISONS LIMITED T/ARHONE-POULENC RORER

UNITED KINGDOM

AEROCROM INHALER AEROSOL N/A FISONS LTD T/A RHONE-POULENC RORER

UNITED KINGDOM

AERODIOL NASAL SPRAY SOLUTION 150MCG/DOSE LES LABORATOIRESSERVIER

FRANCE

AEROLID NEBULIZER SOLUTION 0.1% W/V VECCHI & C. PIAMS.A.P.A.

ITALY

AERO-OM TABLET 40MG OM PORTUGUESA PORTUGAL

AERO-OM ORAL SOLUTION 100MG/ML OM PORTOGUESA PORTUGAL

AERO-OM TABLET 40MG OM PORTUGUESA PORTUGAL

AERO-OM ORAL SOLUTION 100MG/ML OM PORTUGUESA PORTUGAL

AETHOXYSKLEROL 0.5% SOLUTION FORINJECTION

0.5% W/V CHEMISCHE FABRIKKREUSSLER & CO GMBH

GERMANY

AETHOXYSKLEROL 1% SOLUTION FORINJECTION

1% W/V CHEMISCHE FABRIKKREUSSIER & CO GMBH

GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 457

Trade Name Dosage Form Dose MA Holder Country

AETHOXYSKLEROL 2% SOLUTION FORINJECTION

2% W/V CHEMISCHE FABRIKKREUSSIER & CO GMBH

GERMANY

AETHOXYSKLEROL 3% SOLUTION FORINJECTION

3% W/V CHEMISCHE FABRIKKREUSSIER & CO GMBH

GERMANY

AETHOXYSKLEROL 4% SOLUTION FORINJECTION

4% W/V CHEMISCHE FABRIKKREUSSIER & CO GMBH

GERMANY

AETHROMA-30 TIME RELEASE TABLETS 30MG MEPHA PHARMA AG SWITZERLAND

AFLOXAN CAPSULE 150MG ROTTA RESEARCHLABORATORIUM SPA

ITALY

AFLOXAN CREAM 5% W/W ROTTAPHARM S.R.L ITALY

AFRAZINE NASAL SPRAY 0.05% NASAL SPRAY 0.05% W/V SCHERING-PLOUGHLIMITED

UNITED KINGDOM

AGELMIN TABLETS 10MG KLEVA LTD. GREECE

AGGRASTAT 0.25MG/ML CONC. FOR SOLN. FORINFUS

0.25MG/ML MERCK SHARP & DOHMEB.V.

NETHERLANDS

AGIOLAX POWDER FOR ORALSUSP.

NA MADAUS AG GERMANY

AGRIMONY (BACH) ORAL LIQUID N/A NELSON A. & CO LTD UNITED KINGDOM

AILAX ORAL SUSPENSION N/A GALEN LIMITED UNITED KINGDOM

AIMAFIX D.I. SOLUTION FOR IV N/A ISTITUTOSIEROVACCINOGENOITALIANO I.S.I. S.P.A.

ITALY

AIMKIN (BB-K8) INJECTABLE SOLUTION 500MG/2ML BRISTOL MYERS SQUIBBS.P.A

ITALY

AIRCORT NASAL SPRAY 100MCG ITALCHIMICI SPA ITALY

AIRCORT SUSPENSION FORINHALATION

40MG ITALCHIMICI SPA ITALY

AKAMIN TABLET 50MG ALPHAPHARM PTYLIMITED

AUSTRALIA

AKAMIN CAPSULE 100MG ALPHAPHARM PTYLIMITED

AUSTRALIA

AKAMON 1.5MG TABLET 1.5MG MEDOCHEMIE LTD CYPRUS

AKAMON 3MG TABLET 3MG MEDOCHEMIE LTD CYPRUS

AKAMON 6MG TABLET 6MG MEDOCHEMIE LTD CYPRUS

AKATINOL MEMANTINE TABLETS 10 MG MERZ + CO. GMBH & CO. GERMANY

AKILEN 40MG TABLET 40MG MEDOCHEMIE LTD CYPRUS

AKLONIL 0.5MG TABLET 0.5MG MEDOCHEMIE LTD CYPRUS

AKLONIL 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

AKTIFERRIN-F SUSCAPS N/A MEPHA PHARMA AG SWITZERLAND

ALBUMIN 20% — GCPD 50ML SOLUTION FORINJECTION

20% GREENCROSS PLASMADERIVATIVES CORP.

KOREA REPUBLIC

ALBUMIN PHARMACIA SOLUTION FORINFUSION

N/A PHARMACIA & UPJOHNAB

SWEDEN

EL458 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ALBUMIN PHARMACIA SOLUTION FORINFUSION

200MG/ML BIOVITRUM AB SWEDEN

ALCITON METER DOSE NASALSPRAY

100IU/DOSE KLEVA LIMITED GREECE

ALDACTIDE COATED TABLET N/A MONSANTO PLC UNITED KINGDOM

ALDACTIDE 25 TABLETS N/A MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ALDACTONE TABLETS 100MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ALDACTONE COATED TABLET 25MG MONSANTO PLC UNITED KINGDOM

ALDACTONE COATED TABLETS 100MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ALDACTONE TABLETS 25MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ALDACTONE TABLETS 100MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ALDACTONE TABLETS 100MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ALDACTONE TABLET 25MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ALDACTONE 100 MG TABLETS COATED TABLET 100 MG PHARMACIA LIMITED UNITED KINGDOM

ALDACTONE 100MG TABLET 100MG SEARLE PAKISTAN

ALDACTONE 25 MG TABLETS COATED TABLET 25 MG PHARMACIA LIMITED UNITED KINGDOM

ALDACTONE A TABLET 25MG SEARLE PAKISTAN

ALDARA CREAM NA 3M HEALTHCARELIMITED

EUROPEAN COMMUNITY

ALDIX 40MG TABLET 40MG MEDOCHEMIE LTD CYPRUS

ALDOMET TABLET 250MG M.S.D. PAKISTAN

ALDOMET 250MG TABLET 250MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

ALDOMET TABLETS TABLETS 250MG MSD PAKISTAN

ALENOST TABLET 10MG MACLEODSPHARMACEUTICALS LTD

INDIA

ALEXAN SOLUTION FORINJECTION

NA HEINRICH MACK NACHF GERMANY

ALFACALCIDOL (ALPHA D3) CAPSULE 1MCG TEVA PHARMACEUTICALINDUSTRIES LTD

ISRAEL

ALFACIP-0.25MCG CAPSULES CAPSULES 0.25MCG CIPLA LTD. INDIA

ALFINOR 8MG TABLET 8MG MEDOCHEMIE LTD CYPRUS

ALFOXAN CAPSULES 250MG REMEDICA LTD CYPRUS

ALFOXAN SYRUP 50MG/5ML REMEDICA LTD CYPRUS

ALFOXAN 500 F.C. TABLETS 500MG REMEDICA LTD CYPRUS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 459

Trade Name Dosage Form Dose MA Holder Country

ALGESAL SURACTIVE CREAM N/A LABORATOIRES SOLVAYPHARMA

FRANCE

ALGICON TABLET N/A RORERPHARMACEUTICALS LTD.

UNITED KINGDOM

ALGIPAN CREAM N/A WYETH-LEDERLE PAKISTAN

A-LICES SHAMPOO NA HOE PHARMACEUTICALSSDN BHD

MALAYSIA

A-LICES SCALP AND BODYHYGIENE SHAMPOO

SHAMPOO 1% W/V HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

ALKA-SELTZER EFFERVESCENT TABLET 324MG BAYER VITAL GMBH &CO. KG

UNITED KINGDOM

ALKA-SELTZER EFFERVESCENTTABLETS

EFFERVESCENT TABLET N/A BAYER DIAGNOSTICSMANUFACTURINGLIMITED

UNITED KINGDOM

ALKA-SELTZER ORIGINAL EFFERVESCENT TABLET N/A BAYER DIAGNOSTICSMANUFACTURINGLIMITED

UNITED KINGDOM

ALKERAN COMPRESSION-COATEDTABLET

2MG WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

ALKERAN COMPRESSION-COATEDTABLET

5MG WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

ALKERAN POWDER FOR INJECTION 50MG WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

ALKERAN COATED TABLET 2MG THE WELLCOMEFOUNDATION LTD. T/AGLAXO WELLCOME

UNITED KINGDOM

ALKERAN COATED TABLETS 2MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

ALKERAN POWDER AND SOLVENTF/SOLUTION F/INJECTION

NA GLAXOSMITHKLINE SPA ITALY

ALLERGAN CREAM 2G/100G SPA ITALIANALABORATORI BOUTY

ITALY

ALLERGO-COMOD EYE DROPS 20MG/ML URSAPHARMARZNEIMITTEL GMBH

GERMANY

ALLERGOCROM SOLUTION, EYE DROPS 20MG/ML URSAPHARMARZNEIMITTEL GMBH

GERMANY

ALLERGOPOS N EYE DROPS N/A URSAPHARMARZNEIMITTEL GMBH

GERMANY

ALLO-100 TABLET TABLET 100MG CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

ALLOPURINOL TABLETS 300MG DANBURY PHARMACALINC.

PUERTO RICO

ALLOPURINOL TABLETS 100MG TABLETS 100MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

ALLOPURINOL TABLETS 300MG TABLETS 300MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

ALLOPURINOL TABLETS BP TABLETS 100MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

ALLOPURINOL TABLETS BP TABLETS 300MG CP PHARMACEUTICALS UNITED KINGDOM

EL460 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ALLOPURINOL TABLETS BP100MG

TABLETS 100MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

ALLOPURINOL TABLETS BP300MG

TABLET 300MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

ALLUMAG MPS SUSPENSION SUSPENSION N/A CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

ALLUPOL TABLET 100MG GRODZISKPHARMACEUTICALWORKS POLFA

POLAND

ALMIRAL 100MG SUPPOSITORY 100MG MEDOCHEMIE LTD CYPRUS

ALMIRAL 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

ALMIRAL 50MG TABLET 50MG MEDOCHEMIE LTD CYPRUS

ALMIRAL 50MG SUPPOSITORY 50MG MEDOCHEMIE LTD CYPRUS

ALMIRAL 75MG/3ML LIQUID FOR INJECTION 75MG/3ML MEDOCHEMIE LTD CYPRUS

ALMIRAL SR 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS

ALMORA POWD. FOR ORAL SD. 5.9G/SACHET ELPEN S.A. GREECE

ALOMIDE OPHTHALMIC SOLUTION 1MG/ML S.A. ALCON-COUVREURN.V.

BELGIUM

ALOPEXY 2% SOLUTN. FORCUTANEOUS USE

2% W/V LABORATOIRES PIERREFABRE DERMATOLOGIE

FRANCE

ALOPRON 100 TABLETS 100MG REMEDICA LTD CYPRUS

ALOPRON 300 TABLETS 300MG REMEDICA LTD CYPRUS

ALPHA D3 (ALFACALCIDOL) CAPSULE 0.25MCG TEVA PHARMACEUTICALINDUSTRIES LTD

ISRAEL

ALPHADINE FILM-COATED TABLETS 150MG MINERVAPHARMACEUTICAL S.A.

GREECE

ALPHAGAN (BRIMONIDINETARTRATE) 0.2%

OPHTHALMIC SOLUTION 0.2% W/V ALLERGANPHARMACEUTICALS(IRELAND) LTD., INC.

IRELAND

ALPHAMOX POWDER FOR ORALLIQUID

125MG/ML ALPHAPHARM PTYLIMITED

AUSTRALIA

ALPHAMOX POWDER FOR ORALLIQUID

250MG/ML ALPHAPHARM PTYLIMITED

AUSTRALIA

ALPHAMOX 250 CAPSULE 250MG ALPHAPHARM PTYLIMITED

AUSTRALIA

ALPHAMOX 500 CAPSULE 500MG ALPHAPHARM PTYLIMITED

AUSTRALIA

ALPHOSYL CREAM N/A STAFFORD-MILLERLIMITED

UNITED KINGDOM

ALPHOSYL 2 IN 1 SHAMPOO 5% W/W STAFFORD-MILLERLIMITED

UNITED KINGDOM

ALPHOSYL 2 IN 1 SHAMPOO SHAMPOO 5%W/W STAFFORD MILLERLIMITED

UNITED KINGDOM

ALPHOSYL CREAM CREAM NA STAFFORD MILLERLIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 461

Trade Name Dosage Form Dose MA Holder Country

ALPHOSYL HC CREAM N/A STAFFORD-MILLERLIMITED

UNITED KINGDOM

ALPHOSYL HC CREAM CREAM NA STAFFORD-MILLERLIMITED

UNITED KINGDOM

ALPHOSYL LOTION TOPICAL EMULSION N/A STAFFORD-MILLERLIMITED

UNITED KINGDOM

ALPHOSYL LOTION TOPICAL EMULSION NA STAFFORD MILLERLIMITED

UNITED KINGDOM

ALPRENOLOL HCL BP 50MG TABLETS 50MG REMEDICA LTD CYPRUS

ALUDROX LIQUID ORAL GEL 4.16% W/W UNICLIFFE LIMITED T/APFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

ALUMINIUM HYDROXIDESOLVENT

SOLVENT F/PARENTERALUSE

1MG/0.5ML CHIRON S.P.A ITALY

ALUTRIL CHEWABLE TABLETS N/A REMEDICA LTD CYPRUS

ALVEOFACT SUSPENSION 54MG/1.2ML BOEHRINGER INGELHEIMPHARMA KG

GERMANY

ALVERCOL GRANULES GRANULES N/A NORGINE LIMITED UNITED KINGDOM

ALVERIX 5 TABLETS 5MG REMEDICA LTD CYPRUS

ALVITYL COATED TABLET N/A LABORATOIRES SOLVAYPHARMA

FRANCE

ALVITYL SYRUP N/A LABORATOIRES SOLVAYPHARMA

FRANCE

ALYRANE INHALATION LIQUID 99.9% W/V PHARMACIALABORATORIES LIMITED

UNITED KINGDOM

AMAREL 1MG TABLET 1MG LABORATOIRESHOECHST

FRANCE

AMAREL 2MG TABLET 2MG LABORATOIRESHOECHST

FRANCE

AMAREL 3MG TABLET 3MG LABORATOIRESHOECHST

FRANCE

AMAREL 4MG TABLET 4MG LABORATOIRESHOECHST

FRANCE

AMBISONE POWDER FOR INJECTION 50MG NEXSTARPHARMACEUTICALS LTD.

IRELAND

AMBISONE LYOPH. PWDR. FOR IVINF

50MG GILEAD SCIENCESINTERNATIONAL LTD

IRELAND

AMBROHEXAL RETARD SLOW RELEASE CAPSULE 75MG HEXAL AG GERMANY

AMBROHEXAL SAFT SOLUTION 3MG/ML HEXAL AG GERMANY

AMBROLITIC SYRUP 300MG/100ML CHIESI WASSERMANNS.A.

SPAIN

AMBROLITIC 20 CAPSULE 30MG CHIESI WASSERMANNS.A.

SPAIN

AMBROLITIC 20 CAPSULES 30MG CHIESI ESPANA S.A. SPAIN

AMBROLITIC SYRUP SYRUP 328.9MG/100ML CHIESI ESPANA S.A. SPAIN

EL462 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

AMEN 100MG TABLETS TABLETS 100MG MEDOCHEMIE LTD. —CYPRUS

CYPRUS

AMERSCAN (DMSA) AGENT POWDER FOR INJECTION 1MG/VIAL NYCOMED AMERSHAMPLC

UNITED KINGDOM

AMERSCAN MEDRONATE IIAGENT

POWDER FOR INJECTION 6.25MG/VIAL NYCOMED AMERSHAMPLC

UNITED KINGDOM

AMERSCAN PENTETATE II POWDER FOR INJECTION 20.6MG/10ML NYCOMED AMERSHAMPLC

UNITED KINGDOM

AMERSCAN STANNOUS AGENT POWDER FOR INJECTION 4MG/VIAL NYCOMED AMERSHAMPLC

UNITED KINGDOM

A-METHAPRED POWDER FOR INJ. WITHSOLV

40MG/VIAL ABBOTT LABORATORIES UNITED STATES OFAMERICA

AMICLAV TABLETS 250/125 MG FILM COATED TAB GENERICS (UK) LIMITED UNITED KINGDOM

AMIDATE (SINGLE DOSE AMPUL) SOLUTION FORINJECTION

20MG (2MG/ML) ABBOTT LABORATORIES UNITED STATES OFAMERICA

AMIDATE (SINGLE DOSE FLIPTOPVIAL)

SOLUTION FORINJECTION

20MG (2MG/ML) ABBOTT LABORATORIES UNITED STATES OFAMERICA

AMIDATE INJECTION SOLUTION FORINJECTION

2MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

AMIKACINE MERCK 500MG POWDER FOR INJECTION 500MG/VIAL MERCK GENERIQUES FRANCE

AMIKALEM SOLUTION FORINJECTION

100MG/250MG/500 LEMERY S.A. DE C.V MEXICO

AMIKIN INJECTABLE SOLUTION 500MG/2ML BRISTOL-MYERS SQUIBBEESTI AS

ESTONIA

AMIL-CO TABLETS TABLETS N/A NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMILORETIC TABLET N/A PHARMACARE LIMITED SOUTH AFRICA

AMILORIDE HCL TABLETS 5MG TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMILORIDE TABLETS BP TABLETS 5MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

AMILORIDE TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

AMINOPHYLLIN IV-FRESENIUS SOLUTION FORINJECTION

250MG/10ML BODENE (PROPIETARY)LIMITED T/A INTRAMED-SOUTH AFRICA

SOUTH AFRICA

AMINOPHYLLINE SOLUTION FORINJECTION

250MG/10ML DEMO ABEE GREECE

AMINOPHYLLINE TABLETS 225MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMINOPHYLLINE SOLUTION FORINJECTION

250MG PHARMAMEDPARENTERALS LTD.

MALTA

AMINOPHYLLINE BP 250MG TABLETS 250MG REMEDICA LTD CYPRUS

AMINOPHYLLINE BP 360MG SUPPOSITORIES 360MG REMEDICA LTD CYPRUS

AMINOPHYLLINE INJECTION240MG BP

INJECTION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 463

Trade Name Dosage Form Dose MA Holder Country

AMINOPHYLLINE INJECTION BP SOLUTION FORINJECTION

250MG/10ML EVANS MEDICAL LIMITED UNITED KINGDOM

AMINOPHYLLINE INJECTION BP SOLUTION FORINJECTION

250MG/10ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

AMINOPHYLLINE INJECTION BPMINIJET

SOLUTION FORINJECTION

N/A INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

AMINOPHYLLINE INJECTIONMINIJET

SOLUTION FORINJECTION

N/A INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

AMINOPHYLLINE MINJET SOLUTION FORINJECTION

N/A INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

AMINOPHYLLINE TABLETS 100MG TABLET 100MG NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

AMINOPLASMAL 10% INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

AMINOPLASMAL 10% E INFUSION SOLTION N/A B.BRAUN MELSUNGENAG

GERMANY

AMINOPLASMAL 12.5% E INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

AMINOPLASMAL 15% INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

AMINOPLASMAL 15% E INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

AMINOPLASMAL 5% E INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

AMINOPLASMAL HEPA 10% INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

AMINOSYN 10% SOLUTION SOL. FOR I.V. INFUSION N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

AMINOSYN 8.5% WITHELECTROLYTES

SOLUTION FORINJECTION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

AMINOSYN II 10% INJECTION SOL. FOR I.V. INJECTION N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

AMINOSYN II 4.25% M IN 10%DEXTROSE INJ.

SOLUTION FORINJECTION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

AMIODARONE 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

AMIROL 10 TABLETS 10MG REMEDICA LTD CYPRUS

AMIROL 25 TABLETS 25MG REMEDICA LTD CYPRUS

AMITRIPTYLIN SLOVAKOFARMA TABLETS 0.028300G SLOVAKOFARMA SLOVAK REPUBLIC

AMITRIPTYLINE SUGAR COATEDTABLETS

25MG EXTRACTUM-PHARMACO. LTD

HUNGARY

AMITRIPTYLINE TABLET 25MG TABLET 25MG CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

EL464 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

AMITRYPTYLLIN COATED TABLET 25MG ICN POLFA RZESZOWS.A. PHARMACEUTICALWORKS

POLAND

AMLO 10 MG, TABLETS TABLETS 10 MG OMEGA FARMA EHF ICELAND

AMLO 2.5 MG, TABLETS TABLETS 2.5 MG OMEGA FARMA EHF. ICELAND

AMLO 5 MG, TABLETS TABLETS 5 MG OMEGA FARMA EHF. ICELAND

AMOCLAN TABLETS 375MG HIKMAPHARMACEUTICALS

JORDAN

AMOCLAN POWDER FOR INJECTION NA HIKMAPHARMACEUTICALS

JORDAN

AMOX CAPSULE 250MG CAPSULE 250MG CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

AMOXAPEN 125 ORAL SUSPENSION 125MG/5ML REMEDICA LTD CYPRUS

AMOXAPEN 250 CAPSULES 250MG REMEDICA LTD CYPRUS

AMOXAPEN 250 ORAL SUSPENSION 250MG/5ML REMEDICA LTD CYPRUS

AMOXAPEN 250 F.C. TABLETS 250MG REMEDICA LTD CYPRUS

AMOXAPEN 500 CAPSULES 500MG REMEDICA LTD CYPRUS

AMOXAPEN 500 F.C. TABLETS 500MG REMEDICA LTD CYPRUS

AMOXICILLIN CAPSULES 250MG CAPSULE 250MG GENERICS (UK) LIMITED UNITED KINGDOM

AMOXICILLINE CAPSULE 250MG PHARMACEUTICALWORKS POLFA-KRAKOWS.A.

POLAND

AMOXICILLIN-RATIOPHARM250 TS

GRANULES FOR ORALSUSPN.

250MG/5ML RATIOPHARM GMBH GERMANY

AMOXICILLIN-RATIOPHARM 500 FILM COATED TABLETS 500MG RATIOPHARM GMBH GERMANY

AMOXICOMP,,GENERICON FILM COATED TABLET 625 MG GENERICON PHARMAGES.M.B.H.

GERMANY

AMOXIHEXAL 500 FILM-COATED TABLET 500MG HEXAL AG GERMANY

AMOXIHEXAL SAFT DRY SUBSTANCE FORSUSP

200MG/5ML HEXAL AG GERMANY

AMOXIL CAPSULE 250MG SMITH KLINE BEECHAM PAKISTAN

AMOXIL CAPSULE 500MG SMITH KLINE BEECHAM PAKISTAN

AMOXIL SYRUP IN POWDERFORM

125MG/5ML SMITH KLINE &BEECHAM

PAKISTAN

AMOXIL CAPSULE 250MG SMITH KLINE &BEECHAM

PAKISTAN

AMOXIL CAPSULE 500MG SMITH KLINE &BEECHAM

PAKISTAN

AMOXIL CAPSULES 250MG CAPSULE 250MG BEECHAM GROUP PLC UNITED KINGDOM

AMOXIL CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC UNITED KINGDOM

AMOXIL FORTE SYRUP IN POWDERFORM

250MG/5ML SMITH KLINE &BEECHAM

PAKISTAN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 465

Trade Name Dosage Form Dose MA Holder Country

AMOXIL PAEDIATRICSUSPENSION

POWDER FOR ORALSOLUTION

125MG/1.25ML BEECHAM GROUP PLC UNITED KINGDOM

AMOXIL SACHET 3GSUCROSE-FREE

GRANULES FOR ORALSOLN.

3G BEECHAM GROUP PLC UNITED KINGDOM

AMOXIL SYRUP SUCROSE-FREESUSPENSION

POWDER FOR ORALSUSPEN.

125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM

AMOXIL SYRUP SUCROSE-FREESUSPENSION

POWDER FOR ORALSUSPEN.

250MG/5ML BEECHAM GROUP PLC UNITED KINGDOM

AMOXIL VIALS FOR INJECTION250MG

POWDER FOR INJECTION 250MG BEECHAM GROUP PLC UNITED KINGDOM

AMOXIL VIALS FOR INJECTION500MG

POWDER FOR INJECTION 500MG BEECHAM GROUP PLC UNITED KINGDOM

AMOXYCILLIN CAPSULES 250MG NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

AMOXYCILLIN CAPSULES 500MG NORTONPHARMACEUTICALSLIMITED

IRELAND

AMOXYCILLIN CAPSULE 250MG PLIVA PAKISTAN

AMOXYCILLIN 3GM SACHETS S.F. POWDER FOR ORALSOLUTION

3GM NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMOXYCILLIN CAPSULESB.P.500MG

CAPSULES 500MG ATHLONELABORATORIES LIMITED

IRELAND

AMOXYCILLIN MIXTURE ORAL SOLUTION 125MG/5ML NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMOXYCILLIN MIXTURE250MG/5ML

ORAL SOLUTION 250MG/5ML NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMOXYCILLIN S/F MIXTURE125MG/5ML

ORAL SOLUTION 125MG/5ML NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMOXYCILLIN S/F MIXTURE250MG/5ML

ORAL SOLUTION 250MG/5ML NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMOXYCILLIN S/F SACHETS POWDER FORRECONSTITUTION

3MG/5ML NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMOXYCILLIN SUGAR FREESUSPENSION B.P.

SUGAR FREESUSPENSION

125MG/5ML ATHLONELABORATORIES LIMITED

IRELAND

AMOXYDAR CAPSULES 250MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

AMOXYDAR 125 GRANULES FOR ORALSUSPEN.

125MG/5ML DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

AMPHOCIL POWDER FOR SOLUTIONFOR INFUSION

50MG INTERMUNE EUROPELIMITED

UNITED KINGDOM

AMPICILLIN CAPSULES 250MG CAPSULES 250MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMPICILLIN CAPSULES 500MG CAPSULES 500MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

AMPICLLIN CAPSULES B.P. CAPSULES 500MG ATHLONELABORATORIES LIMITED

IRELAND

EL466 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

AMPICLOX CAPSULE N/A SMITH KLINE &BEECHAM

PAKISTAN

AMPICLOX CAPSULES 500MG CAPSULE N/A BEECHAM GROUP PLC UNITED KINGDOM

AMPICLOX INJECTION 500MG POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM

AMPICLOX NEONATAL INJECTION POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM

AMPICLOX NEONATALSUSPENSION

POWDER FOR ORALSUSPEN.

N/A BEECHAM GROUP PLC UNITED KINGDOM

AMPICLOX SYRUP POWDER FOR SYRUP N/A BEECHAM GROUP PLC UNITED KINGDOM

AMPISUL 250 CAPSULES 250MG AEGIS LTD. CYPRUS

AMPISUL 500 CAPSULES 500MG AEGIS LTD. CYPRUS

AMSIDINE 50 MG/ML SOLUTION FORINJECTION

50 MG/ML GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

AMSIDINE INJECTION SOLUTION FORINJECTION

50MG/ML GOLDSHIELDPHARMACEUTICALS LTD

UNITED KINGDOM

AMURETIC TABLETS NA DAR ALA DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

ANABACT METRONIDAZOLETOPICAL GEL 0.75%

GEL 0.75% W / W BIOGLANPHARMACEUTICALS LTD

UNITED KINGDOM

ANACAINE INJECTION 1% SOLUTION FORINJECTION

10MG/ML SM PHARMACEUTICALSSDN. BHD.

MALAYSIA

ANACAL RECTAL OINTMENT RECTAL OINTMENT N/A SANKYO PHARMA UKLIMITED

UNITED KINGDOM

ANACAL SUPPOSITORIES SUPPOSITORY N/A SANKYO PHARMA UKLIMITED

UNITED KINGDOM

ANADIN TABLETS N/A WHITEHALLLABORATORIES LTD

UNITED KINGDOM

ANADIN EXTRA / POWERIN TABLETS N/A WHITEHALLLABORATORIES LTD

UNITED KINGDOM

ANADIN PARACETAMOL TABLETS 500MG WHITEHALLLABORATORIES LTD

UNITED KINGDOM

ANAFRANIL SUGAR COATEDTABLETS

10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ANAFRANIL SUGAR COATEDTABLETS

25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ANAFRANIL TABLET 10MG NOVARTIS PAKISTAN

ANAFRANIL TABLET 25MG GEIGY PAKISTAN

ANAFRANIL TABLET 25MG NOVARTIS PAKISTAN

ANAFRANIL S/C TABLETS 10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ANAFRANIL FIM-COATED TABLET 75MG NOVARTISFARMACEUTICA S.A. —SPAIN

SPAIN

ANAFRANIL SUGAR-COATEDTABLETS

10MG NOVARTISFARMACEUTICA S.A

SPAIN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 467

Trade Name Dosage Form Dose MA Holder Country

ANAFRANIL SUGAR-COATEDTABLETS

25MG NOVARTISFARMACEUTICA S.A

SPAIN

ANAFRANIL SUGAR (FILM)-COATEDTABLETS

10MG NOVARTIS FARMA SPA ITALY

ANAFRANIL SUGAR (FILM)-COATEDTABLETS

25MG NOVARTIS FARMA SPA ITALY

ANAFRANIL SR 75 DIVITABS 75MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ANAPRIN TABLETS TABLETS 75MG OPAL PAKISTAN

ANARGIL 100MG CAPSULE 100MG MEDOCHEMIE LTD CYPRUS

ANARGIL 200MG CAPSULE 200MG MEDOCHEMIE LTD CYPRUS

ANATOXAL DI TE BERNA SOUTION FOR INJECTION N/A ISTITUTOSIEROTERAPICO BERNAS.R.L.

ITALY

ANCID CHEWING TABLET 500MG HEXAL AG GERMANY

ANCOPIR TABLET N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

ANCOTIL SOLUTION FORINJECTION

2.5G/250ML ICN PHARMACEUTICALSLIMITED

UNITED KINGDOM

ANCOTIL SOLUTION FORINJECTION

2.5G/250ML ICN PHARMACEUTICALSLIMITED

UNITED KINGDOM

ANCOTIL 2.5G/250ML SOLUTION FORINJECTION

N/A ICN PHARMACEUTICALSLIMITED

UNITED KINGDOM

ANDRACTIM GEL N/A BESINS INTERNATIONAL FRANCE

ANDREWS ANTACID TABLETS TABLET N/A SMITHKLINE BEECHAM(SWG) LTD T/A STERLINGHEALTH

UNITED KINGDOM

ANDRIOL CAPSULES 40MG N.V. ORGANON NETHERLANDS

ANDROCUR TABLET 50MG SCHERING AG GERMANY

ANDROCUR TABLET 50MG SCHERING S.A. FRANCE

ANDROCUR-10 TABLET 10MG SCHERING AG GERMANY

ANDROCUR-DEPOT OILY SOLN FOR IMINJECT.

100MG/ML SCHERING AG GERMANY

ANECTINE SOLUTION FORINJECTION

5%W/V THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

ANECTINE SOLUTION FORINJECTION

5%W/W THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

ANECTINE (MIDARINE) SOLUTION FORINJECTION

5% W/V WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

ANEXATE AQUEOSUS SOLUTION 0.5MG/5ML ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

ANGINESIN LIQUID N/A DR. GROSSMAN AGPHARMACA

SWITZERLAND

ANGINOVAG AEROSOL N/A LABORATORIOS NOVAG,S.A.

SPAIN

EL468 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ANGIOCIS POWDER FOR INJECTION N/A CIS BIO INTERNATIONAL FRANCE

ANGISED TABLETS TABLETS 0.5MG GLAXOWELLCOME PAKISTAN

ANGISED TABLETS TABLETS 0.5MG GLAXOSMITHKLINESOUTH AFRICA (PTY)LTD

SOUTH AFRICA

ANGISPRAY SPRAY SOLN F/ORALCAVITY

N/A LABORATOIRES MONOT FRANCE

ANTACID PLUS ANTIFLATULENT SUSPENSION N/A STANLEYPHARMACEUTICALS LTD

CANADA

ANTHISAN CREAM 2% W/W CREAM 2% W/W MAY & BAKER LIMITED(T/A RHONE-POULENCRORER)

UNITED KINGDOM

ANTIBIOPTAL EYE DROPS N/A FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

ANTIBIOTIC OINTMENT OINTMENT N/A STANLEYPHARMACEUTICALS LTD

CANADA

ANTIBLUT S.R.F.C. TABLET 20MG GENEPHARM S.A. GREECE

ANTIDOL COATED TABLETS 500MG LABORATORIOS CINFAS.A

SPAIN

ANTIGREG TABLET 250MG VECCHI & C PIAMS.A.P.A.

ITALY

ANTIGREG TABLET 250MG VECCHI & C PIAM ITALY

ANTILIPID FILM COATED TABLETS 600MG KLEVA LIMITED GREECE

ANTIPEOL OINTMENT OINTMENT N/A MEDICO-BIOLOGICALLABS LTD

UNITED KINGDOM

ANTIPHLOGISTINE PASTE FOR TOPICALAPPLIC.

N/A LABORATOIRESFUMOUZE

FRANCE

ANTIPREX TABLETS 5MG ELPEN PHARM. CO. INC. GREECE

ANTIRRINUM NASAL SPRAY SOLUTION NA LABORATORIO REIGJOFRE S.A

SPAIN

ANTISPASMINA COLICA GASTRORESISTANTTABLET

N/A RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

ANTISPASMINA COLICA (FORTE) GASTRORESISTANTTABLET

N/A RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

ANTITHROMBIN III HUMANTHROMBHIBIN

SOLUTION FORINJECTION

N/A BAXTER AG AUSTRIA

ANTI-THYROX TABLETS 5MG MACLEODSPHARMACEUTICALS LTD

INDIA

ANTORAL SOLUTION FOR BUCCALUSE

0.05G/100ML RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

ANTORAL LOZENGE (THROAT) 5MG RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

ANUSOL SUPPOSITORY N/A PARKE DAVIS FRANCE

ANUSOL RECTAL OINTMENT N/A PARKE DAVIS FRANCE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 469

Trade Name Dosage Form Dose MA Holder Country

ANUSOL SUPPOSITORIES SUPPOSITORY N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

ANXETIN CAPSULES 20MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

ANXIOLAN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

ANZEMET 100MG/5ML SOLUTION FOR IVINJECTION

100MG/5ML LABORATOIRES AVENTIS FRANCE

ANZEMET 12.5MG/0.625ML SOLUTION FOR IVINJECTION

12.5MG/0.625ML LABORATOIRES AVENTIS FRANCE

ANZEMET 200MG COATED TABLET 200MG LABORATOIRESROUSSEL DIAMANT

FRANCE

APIOCOLINA CREAM 106MG/100G BRUSCHETTINI SRL ITALY

APIOCOLINA SUPPOSITORY 4MG BRUSCHETTINI SRL ITALY

APO ACETAZOLAMIDETAB 250MG

TABLET 250MG APOTEX INC CANADA

APO ALLOPURINOL 100MG TABLET 100MG APOTEX INC CANADA

APO AMPI CAPSULES 500MG CAPSULE 500MG APOTEX INC CANADA

APO CIMETIDINE TAB 200MG TABLET 200MG APOTEX INC CANADA

APO FOLIC ACID TAB 5MG TABLET 5MG APOTEX INC CANADA

APO GLYBURIDE TAB 2.5MG TABLET 2.5MG APOTEX INC CANADA

APO IMIPRAMINE TAB 10MG TABLET 10MG APOTEX INC CANADA

APO IMIPRAMINE TAB 25MG TABLET 25MG APOTEX INC CANADA

APO ISDN TABLET 10MG APOTEX INC CANADA

APO PRIMIDONE TABLET 250MG APOTEX INC CANADA

APO SULFATRIM TAB TABLET N/A APOTEX INC CANADA

APO TETRA CAP 250MG CAPSULE 250MG APOTEX INC CANADA

APO THIORIDAZINE TABLET 10MG APOTEX INC CANADA

APO TRIHEX TAB 2MG TABLET 2MG APOTEX INC CANADA

APO ZIDOVUDINE CAP 100MG CAPSULE 100MG APOTEX INC CANADA

APO-ALPRAZ TAB 0.5MG TABLET 0.5MG APOTEX INC CANADA

APO-AMITRIPTYLINE HCLTAB 25MG

TABLET 25MG APOTEX INC CANADA

APO-AMOXI CAP 500MG CAPSULE 500MG APOTEX INC CANADA

APO-ATENOLOL TABLET 100MG APOTEX INC CANADA

APO-CEPHALEX TAB 500MG TABLET 500MG APOTEX INC CANADA

APO-CLOMIPRAMINE TABLETS10MG

TABLET 10MG APOTEX INC CANADA

APO-CLOMIPRAMINE TABLETS25MG

TABLET 25MG APOTEX INC CANADA

EL470 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

APO-DICLO SR 100MG MODIFIED RELEASETABLET

100MG APOTEX INC CANADA

APO-DOXY CAP 100MG CAPSULE 100MG APOTEX INC CANADA

APO-FLUOXETINE — CAP 20MG CAPSULE 20MG APOTEX INC CANADA

APO-GLYBURIDE TAB 5MG TABLET 5MG APOTEX INC CANADA

APO-PREDNISONE 5MG TABLETS TABLET 5MG APOTEX INC CANADA

APO-RANITIDINE 300MG TABLETS 300MG APOTEX INC CANADA

APO-RANITIDINE TAB 150MG TABLET 150MG APOTEX INC CANADA

APRAZOL CAPSULES 30MG HUSNU ARSAN ILACLARIA.S.

TURKEY

APRAZOL ENTERIC COATEDCAPSULE30M

30MG HUSNU ARSAN ILACLARIA.S.- TURKEY

TURKEY

APRESOLINE SUGAR COATEDTABLETS

10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

APRESOLINE SUGAR COATEDTABLETS

25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

APROTININ INJECTION SOLUTION FORINJECTION

10 KIU/ML FERRINGPHARMACEUTICALS LTD

UNITED KINGDOM

APROVEL 150MG TABETS TABLET 150MG SANOFI PHARMABRISTOL-MYERS SQUIBBSNC

FRANCE

APROVEL 300MG TABLETS TABLET 300MG SANOFI PHARMABRISTOL-MYERS SQUIBBSNC

FRANCE

APROVEL75MG TABLET TABLET 75MG SANOFI PHARMABRISTOL-MYERS SQUIBBSNC

FRANCE

AQUEOUS CREAM BP CREAM 9% W/W ADAMS HEALTHCARELIMITED

UNITED KINGDOM

AQUEOUS CREAM BP CREAM NO ACTIVE ING. THORNTON & ROSS LTD UNITED KINGDOM

AQUEOUS CREAM BP CREAM N/A RUSCO LIMITED T/ARUSCOPHARMACEUTICALS

UNITED KINGDOM

ARAVA FILM-COATED TABLET 10MG HOECHST MARIONROUSSEL DEUTSCHLANDGMBH

GERMANY

ARAVA FILM-COATED TABLET 20MG HOECHST MARIONROUSSEL DEUTSCHLANDGMBH

GERMANY

ARAVA FILM-COATED TABLET 100MG HOECHST MARIONROUSSEL DEUTSCHLANDGMBH

GERMANY

ARCALION TABLETS 200MG SERVIER PAKISTAN

ARCALION 200MG COATED TABLETS SERVIER EGYPTINDUSTRIES LTD

EGYPT

ARCALION 200MG COATED TABLET 200MG LABORATOIRES SERVIER FRANCE

ARCALION TABLETS TABLETS 200MG SERVIER PAKISTAN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 471

Trade Name Dosage Form Dose MA Holder Country

ARCOXIA FILM-COATED TABLETS 120MG MERCK SHARP ANDDOHME LIMITED

UNITED KINGDOM

ARCOXIA FILM COATED TABLETS 90MG MERCK SHARP & DOHMELIMITED

UNITED KINGDOM

ARCOXIA FILM COATED TABLETS 60MG MERCK SHARP & DOHMELIMITED

UNITED KINGDOM

AREDIA DRY SUBSTANCE FORINJ.

15MG/VIAL NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

AREDIA POWDER FOR INJECTION 30MG/VIAL NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

AREDIA POWDER FOR INJECTION 60MG/VIAL NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

AREDIA POWDER FOR INJECTION 90MG/VIAL NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

AREDIA POWDER FOR INFUSION 15MG NOVARTISFARMACEUTICA S.A. —SPAIN

SPAIN

AREDIA POWDER FOR INFUSION 30MG NOVARTISFARMACEUTICA S.A. —SPAIN

SPAIN

AREDIA POWDER FOR INFUSION 60 MG NOVARTISFARMACEUTICA S.A. —SPAIN

SPAIN

AREDIA POWDER FOR INFUSION 90MG NOVARTISFARMACEUTICA S.A. —SPAIN

SPAIN

ARESTON TABLETS 50MG MEDOCHEMIE LTD. CYPRUS

ARFEN SUSPENSION 120MG/5ML MEDOCHEMIE LTD CYPRUS

ARFEN 125MG SUPPOSITORY 125MG MEDOCHEMIE LTD CYPRUS

ARFEN 250MG SUPPOSITORY 250MG MEDOCHEMIE LTD CYPRUS

ARFEN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

ARFEN 500MG SUPPOSITORY 500MG MEDOCHEMIE LTD CYPRUS

ARICEPT 10MG COATED TABLET 10MG EISAI LIMITED UNITED KINGDOM

ARIDIL TABLETS N/A CP PHARMACEUTICALSLTD.

UNITED KINGDOM

ARIDIL TABLETS N/A CP PHARMACEUTICALSLTD.

UNITED KINGDOM

ARIDIL TABLETS N/A CP PHARMACEUTICALSLTD.

UNITED KINGDOM

ARIDIL TABLET N/A CP PHARMACEUTICALSLTD

UNITED KINGDOM

ARIDIL TABLET N/A CP PHARMACEUTICALSLTD

UNITED KINGDOM

ARIDIL TABLET N/A CP PHARMACEUTICALSLTD

UNITED KINGDOM

ARILVAX — YELOW FEVERVACCINE

FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM

EL472 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ARIMIDEX COATED TABLET 1MG ZENECA LIMITED UNITED KINGDOM

ARISTIN-C INJ.SOLUTION OFINFUSION

200MG/100ML ANFARM HELLAS S.A. GREECE

ARISTIN-C FILM COATED TABLETS 500MG ANFARM HELLAS S.A. GREECE

ARISTIN-C FILM-COATED TABLET 250MG ANFARM HELLAS S.A GREECE

ARNETIN 150MG TABLET 150MG MEDOCHEMIE LTD CYPRUS

ARNETIN 50MG/2ML LIQUID FOR INJECTION 50MG/2ML MEDOCHEMIE LTD CYPRUS

ARNICA CREAM 9% A NELSON ANDCOMPANY LTD

UNITED KINGDOM

AROMASIN COATED TABLETS 25MG PHARMACIA & UPJOHNLIMITED

ITALY

AROMASIN FILM-COATED TABLETS 25MG PHARMACIA ITALIA SPA ITALY

ARPHOS ORAL SOLUTION N/A LABORATORIESFOURNIER S.A.

FRANCE

ART CAPSULE 50MG LABORATOIRES NEGMA FRANCE

ART 50 CAPSULES 50MG NEGMA-LERADS FRANCE

ARTANE TABLETS 2MG CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

ARTEX 5MG SCORED COATEDTABLET

5MG LES LABORATOIRESSERVIER

FRANCE

ARTHRINAL F.C. TABLETS 20MG REMEDICA LTD CYPRUS

ARTHROTEC 50 TABLETS N/A MONSANTO PLC UNITED KINGDOM

ARTHROTEC 50 TABLETS GASTRO-RESISTANTTABLETS

N/A MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ARTHROTEC 50 TABLETS GASTRO-RESISTANTTABLET

N/A PHARMACIA LIMITED UNITED KINGDOM

ARTHROTEC 75 TABLETS N/A MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ARTHROTEC 75 GASTRO RESISTANTTABLET

NA MONSANTO PLC T/ASEARLE

UNITED KINGDOM

ARTHROTEC TABLETS TABLETS NA SEARLE PAKISTAN

ARTHROXEN TABLET 250MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

ARTHROXEN TABLET 500MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

ARTROSILENE FOAM N/A DOMPE FARMACEUTICISPA

ITALY

ARTROSILENE GEL N/A DOMPE FARMACEUTICISPA

ITALY

ARTROSILENE «RETARD» CAPSULES 320MG DOMPE FARMACEUTICISPA

ITALY

ARTROXICAM CAPSULE 20MG FONTEN FARMACEUTICIS.R.L.

ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 473

Trade Name Dosage Form Dose MA Holder Country

ASCARD TABLETS 75MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

ASCARD TABLETS 300MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

ASCARD TABLETS 150MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

ASCORBIC ACID 100MG TABLETS 100MG PHARMAMED LTD. MALTA

ASCORBIC ACID 250MG TABLETS 250MG PHARMAMED LTD. MALTA

ASCORBIC ACID 500MG CHEWABLE TABLETS 500MG PHARMAMED LTD. MALTA

ASCORBIC ACID BP 100MG TABLET 100MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

ASCORBIC ACID BP 200MG TABLET 200MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

ASCORBIC ACID BP 500MG TABLET 500MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

ASCORBIC ACID BP 50MG TABLET 50MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

ASCORBIC ACID INJECTIONAMPOULE

SOLUTION FORINJECTION

500MG/5ML F.H. FAULDING & CO LTD(T/A DAVID BULL LABS)

AUSTRALIA

ASCORBIC ACID INJECTION BPC SOLUTION FORINJECTION

500MG/5ML EVANS MEDICAL LIMITED UNITED KINGDOM

ASCOSAL EFFERVESCENT TABLETS N/A DR. GROSSMAN AGPHARMACA

SWITZERLAND

ASCRIPTIN TABLET N/A RORERPHARMACEUTICALS LTD.(T/A RHONE POULENCRORER)

UNITED KINGDOM

ASERBINE TOPICAL SOLUTION NA FORLEY LIMITED T/AFORLEYPHARMACEUTICALS

UNITED KINGDOM

ASERBINE CREAM NA FORLEY LIMITED T/AFORLEYPHARMACEUTICALS

UNITED KINGDOM

ASILONE ANTACID LIQUID ORAL SUSPENSION N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

ASILONE ANTACID TABLETS TABLETS N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

ASILONE HEARTBURN LIQUID ORAL SUSPENSION N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

ASILONE HEARTBURN TABLETS TABLETS N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

ASMABEC INHALATION POWDER 50MCG/AC MEDEVA PHARMALIMITED

UNITED KINGDOM

ASMABEC CLICKHALER INHALATION POWDER 250MCG/AC MEDEVA PHARMALIMITED

UNITED KINGDOM

EL474 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ASMABEC CLICKHALER 100 INHALATION POWDER 100MCG/AC MEDEVA PHARMALIMITED

UNITED KINGDOM

ASMASAL CLICKHALER INHALATION POWDER 95MCG/AC MEDEVA PHARMALIMITED

UNITED KINGDOM

ASMOVAL TABLETS 10MG REMEDICA LTD CYPRUS

ASPARAGINASE 10000 MEDAC POWDER FOR INJECTION 10000IU MEDAC GMBH GERMANY

ASPEGIC 500MG POWDER FOR ORAL SOL. 500MG/SACHET LABORATOIRESSYNTHELABO

FRANCE

ASPEGIC FOR INJECTION500MG/5ML

POWDER FORINJECTABLE SOL

500MG/5ML LABORATOIRESSYNTHELABO

FRANCE

ASPIREM 125 SUPPOSITORIES 125MG REMEDICA LTD CYPRUS

ASPIREM 150 E.C. TABLETS 150MG REMEDICA LTD CYPRUS

ASPIREM 300 E.C. TABLETS 300MG REMEDICA LTD CYPRUS

ASPIREM 75 E.C. TABLETS 75MG REMEDICA LTD CYPRUS

ASPIRIN ENTERIC COATEDTABLET

75MG THE WALLISLABORATORY LIMITED

UNITED KINGDOM

ASPIRIN TABLETS 75MG PHARMAMED LTD. MALTA

ASPIRIN TABLETS 75MG PHARMAMED LTD. MALTA

ASPIRIN TABLETS 300MG M & A PHARMACHEMLIMITED

UNITED KINGDOM

ASPIRIN BP 300MG TABLET 300MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

ASPIRIN BP 75MG TABLET 75MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

ASPIRIN PLUS C EFFERVESCENT TABLET N/A BAYER VITAL GMBH &CO. KG

GERMANY

ASPIRIN PROTECT 100 ENTERIC COATEDTABLET

100MG BAYER VITAL GMBH &CO. KG

GERMANY

ASPIRIN PROTECT 300 ENTERIC COATEDTABLET

300MG BAYER VITAL GMBH &CO. KG

GERMANY

ASPIRIN TABLETS 75MG EC GASTRO-RESISTANTTABS

75MG THE WALLISLABORATORY LIMITED

UNITED KINGDOM

ASPIRIN TABLETS DISPERSIBLE BP DISPERSIBLE TABLETS 75MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

ASPRO 320MG TABLET 320MG LABORATOIRES ROCHENICHOLAS S.A.

FRANCE

ASPRO 500MG EFFERVESCENT TABLET 500MG LABORATOIRES ROCHENICHOLAS S.A.

FRANCE

ASTHALIN 4 TABLET TABLET 4MG CIPLA LTD. INDIA

ASTHALIN INHALER INHALATION AEROSOL 100MCG/DOSE CIPLA LIMITED INDIA

ASTHALIN RESPIRATORSOLUTION

RESPIRATOR SOLUTION 5MG/1ML CIPLA LIMITED INDIA

ASTHALIN SYRUP SYRUP N/A CIPLA LTD INDIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 475

Trade Name Dosage Form Dose MA Holder Country

ASTIZOL TABLETS 10MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

ASTRIX 100 CAPSULE 100MG FAULDINGPHARMACEUTICALS

AUSTRALIA

ASYRAN TABLETS 150MG DELTA HF ICELAND

ASYRAN TABLETS 300MG DELTA HF ICELAND

ATACAND TABLET 16MG ASTRAPHARMACEUTICALSLIMITED

SWEDEN

ATACAND 8MG TABLET 8MG ASTRAPHARMACEUTICALS LTD

SWEDEN

ATALINE 2.5MG TABLET 2.5MG MEDOCHEMIE LTD CYPRUS

ATARAX FILM-COATED TABLET 25MG U.C.B. S.A. BELGIUM

ATARAX SYRUP 2MG/ML U.C.B. S.A. BELGIUM

ATARAX TABLET 25MG UNITED CHEMICALS OFBELGIUM

PAKISTAN

ATENOLOL TABLETS 50MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

ATENOLOL TABLETS 100MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

ATENOLOL TABLETS 100MG PHARMAMED LTD. MALTA

ATENOLOL TABLETS 50MG PHARMAMED LTD. MALTA

ATENOLOL COATED TABLETS 100MG GENERICS (UK) LIMITED UNITED KINGDOM

ATENOLOL DELTA TABLETS 25MG DELTA HF ICELAND

ATENOLOL DELTA TABLETS 50MG DELTA HF ICELAND

ATENOLOL DELTA TABLETS 100MG DELTA HF ICELAND

ATENOLOL DENK 50 FILM-COATED TABLETS 50MG E.DENK OHG GERMANY

ATENSIN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

ATENSIN 40MG TABLET 40MG MEDOCHEMIE LTD CYPRUS

ATIVAN TABLETS 2.5MG JOHN WYETH &BROTHER LIMITED T/AWYETH LABORATORIES

IRELAND

ATIVAN 1MG TABLETS 1MG WYETH-PHARMA GMBH GERMANY

ATIVAN 1MG TABLETS 1MG JOHN WYETH ANDBROTHER LTD T/AWYETH LABORATORIES

UNITED KINGDOM

ATIVAN 2MG TABLET 2MG WYETH-PHARMA GMBH GERMANY

ATIVAN 2MG TABLETS 2MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES

IRELAND

ATODEL TABLETS 1MG REMEDICA LTD. CYPRUS

ATODEL TABLETS 2MG REMEDICA LTD. CYPRUS

EL476 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ATODEL 1 TABLETS 1MG REMEDICA LTD CYPRUS

ATODEL 2 TABLETS 2MG REMEDICA LTD CYPRUS

ATODEL 5 TABLETS 5MG REMEDICA LTD CYPRUS

ATOMASE AQUEOUS NASALSPRAY

NASAL SPRAY 50MCG/DOSE DOUGLASPHARMACEUTICALS LTD.

NEW ZEALAND

ATROMID-S CAPSULES 500MG ZENECA LIMITED UNITED KINGDOM

ATROPINA 1% FARMIGEA OPHTHALMIC DROPS 5MG FARMIGEA SPA ITALY

ATROPINE SOLUTION FORINJECTION

0.5MG/ML PHARMAMEDPARENTERALS LTD.

MALTA

ATROPINE DISPERSA 1% EYE DROPS 1% W/V CIBA VISION AG SWITZERLAND

ATROPINE DISPERSA 1.0% EYE DROPS 10.0MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

ATROPINE INJECTION BPMINIJECT

SOLUTION FORINJECTION

N/A INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

ATROPINE INJECTION BP MINIJET SOLUTION FORINJECTION

0.1MG/ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

ATROPINE MINIJET SOLUTION FORINJECTION

0.1MG/ML INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

ATROPINE SULFATE INJECTIONUSP

SOLUTION FORINJECTION

0.1MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

ATROPINE SULPHATE TABLETS 600 MCG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

ATROPINE SULPHATE TABLETS 600MCG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

ATROPINE SULPHATE SOLUTION FORINJECTION

600MCG/ML ANTIGENPHARMACEUTICALS

IRELAND

ATROPINE SULPHATE INJECTION0.5MG

INJECTION SOLUTION 0.05% W/V B.BRAUN MELSUNGENAG

GERMANY

ATROPINE SULPHATE INJECTION1MG

INJECTION SOLUTION 0.1% W/V B.BRAUN MELSUNGENAG

GERMANY

ATROPINE SULPHATE INJECTIONBP

SOLUTION FORINJECTIONS

600MCG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

ATROPINE SULPHATE INJECTIONBP 600MCG/ML

SOLUTION FORINJECTION

600MCG/ML MACARTHYSLABORATORIES LIMITEDT/A MARTINDALELIMITED

UNITED KINGDOM

ATROVENT NEBULISER SOLUTION 500MCG/2ML BOEHRINGER INGELHEIMLTD

UNITED KINGDOM

ATROVENT N METERED AEROSOL PUFF SOLUTION 20MCG BOEHRINGER INGELHEIMPHARMA KG —GERMANY

GERMANY

ATROVENT NASAL PUMP SPRAY0.03%

NASAL PUMP SPRAY 0.314MG/ML BOEHRINGER INGELHEIMPHARMA KG

GERMANY

AUDAX EAR DROPS DROPS N/A MUNDIPHARMAPHARMACEUTICALS LTD.

CYPRUS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 477

Trade Name Dosage Form Dose MA Holder Country

AUGMENTIN TABLET 375MG SMITH KLINE &BEECHAM

PAKISTAN

AUGMENTIN TABLET N/A SMITH KLINE &BEECHAM

PAKISTAN

AUGMENTIN 1.2G IV POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN 156MG SUSPENSION POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN 1G COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN 228MG SUSPENSION POWDER FOR ORALSUSPEN.

N/A SMITHKLINE BEECHAMPLC

UNITED KINGDOM

AUGMENTIN 312MG SUSPENSION POWDER FOR ORALSOLUTION

N/A BEECHAM PLC UNITED KINGDOM

AUGMENTIN 457MG SUSPENSION POWDER FOR ORALSUSPEN.

N/A SMITHKLINE BEECHAMPLC

UNITED KINGDOM

AUGMENTIN 600MG IV POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN 625MG TABLETS COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN 625MG TABS. TWICEDAILY DOSING

COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN DISPERSIBLETABLETS 375MG

TABLET FOR ORALSOLUTION

N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN INFANT DROPS POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN TABLETS 375MG COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM

AULIN TABLETS 100MG HELSINN BIREXPHARMACEUTICALS LTD.

IRELAND

AULIN ORAL POWDER FORRECON.

100MG/SACHET HELSINN BIREXPHARMACEUTICALS LTD.

IRELAND

AUNATIV SOLUTION FORINJECTION

250IU/ML PHARMACIA & UPJOHNAB

SWEDEN

AUNATIV SOLUTION FORINJECTION

SOLUTION FORINJECTION

200IU/ML BIOVITRUM SWEDEN

AUREOMYCIN OINTMENT OINTMENT 3% W/W CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

AUREOMYCIN SALBE OINTMENT 3G/100G LEDERLE ARZNEIMITTELGMBH & CO

GERMANY

AUREOMYCINE MONOT 3% OINTMENT 3% LABORATOIRES MONOT FRANCE

AURIGOUTTE EAR DROPS N/A LABORAOIRES MONOT FRANCE

AVALOX 400MG FILM-COATED TABLET 400MG BAYER VITAL GMBH &CO. KG

GERMANY

AVANDIA TABLET 2MG SMITHKLINE BEECHAMCORPORATION

UNITED STATES OFAMERICA

AVANDIA TABLET 4MG SMITHKLINE BEECHAMCORPORATION

UNITED STATES OFAMERICA

AVANDIA TABLET 8MG SMITHKLINE BEECHAMCORPORATION

UNITED STATES OFAMERICA

EL478 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

AVANDIA FILM-COATED TABLETS 1MG SMITHKLINE BEECHAMPLC

EUROPEAN COMMUNITY

AVANDIA FILM-COATED TABLETS 2MG SMITHKLINE BEECHAMPLC

EUROPEAN COMMUNITY

AVANDIA FILM COATED TABLETS 4MG SMITHKLINE BEECHAMPLC

EUROPEAN COMMUNITY

AVANDIA FILM COATED TABLETS 8MG SMITHKLINE BEECHAMPLC

EUROPEAN COMMUNITY

AVANT 1.5MG TABLET 1.5MG MEDOCHEMIE LTD CYPRUS

AVANT 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

AVANT 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

AVAXIM SUSPENSION FORINJECTION

160 AU/0.5ML PASTEUR MERIEUX FRANCE

AVELOX FILM-COATED TABLET 400MG BAYER VITAL GMBH &CO. KG

GERMANY

AVERNOL TABLETS 25MG MEDOCHEMIE LTD. CYPRUS

AVIPUR TABLETS 50,000IU TAROPHARMACEUTICALINDUSTRIES LTD.

ISRAEL

AVIPUR TABLETS TABLET 50,000 IU TAROPHARMACEUTICALINDUSTRIES LTD

ISRAEL

AVIRAL-200 TABLETS 200MG MEPHA PHARMA AG SWITZERLAND

AVIRAL-400 TABLETS 400MG MEPHA PAHRMA AG SWITZERLAND

AVIRAL-800 TABLETS 800MG MEPHA PHARMA AG SWITZERLAND

AVOCLOR TABLET 250MG ZENECA LIMITED UNITED KINGDOM

AVOMINE TABLETS 25MG MANX PHARMA LIMITED UNITED KINGDOM

AVOMINE TABLET 25MG RHONE-POULENC RORERPAKISTAN (PVT) LIMITED

PAKISTAN

AVONEX POWDER + SOLVENTFOR INJ.

30UG/ML BIOGEN FRANCE S.A. FRANCE

AVONEX POWDER AND SOLVENTFOR INJ

30MCG BIOGEN FRANCE S.A. EUROPEAN COMMUNITY

AXETINE 250MG POWDER FOR INJECTION 250MG MEDOCHEMIE LTD CYPRUS

AXETINE 750MG POWDER FOR INJECTION 750MG MEDOCHEMIE LTD CYPRUS

AXSAIN CREAM 0.075% W / W BIOGLANLABORATORIES LTD

UNITED KINGDOM

AXURA FILM-COATED TABLETS 10MG MERZPHARMACEUTICALSGMBH

EUROPEAN COMMUNITY

AXURA ORAL DROPS SOLUTION 10MG/G MERZPHARMACEUTICALSGMBH

EUROPEAN COMMUNITY

AZACTAM POWDER FOR INJECTION 500MG BRISTOL-MYERS SQUIBBS.P.A

ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 479

Trade Name Dosage Form Dose MA Holder Country

AZACTAM POWDER FOR INJECTION 1G BRISTOL-MYERS SQUIBBS.P.A

ITALY

AZACTAM POWDER FOR INJECTION 1G E R SQUIBB & SONSLIMITED

UNITED KINGDOM

AZACTAM POWDER FOR INJECTION 2GM ER SQUIBB & SONSLIMITED

UNITED KINGDOM

AZAMUN FILM COATED TABLET 50MG DOUGLASPHARMACEUTICALS LTD

NEW ZEALAND

AZANTAC 150MG EFFERVESCENT TABLET 150MG GLAXO WELLCOME FRANCE

AZANTAC 300MG EFFEVESCENT TABLET 300MG GLAXO WELLCOME FRANCE

AZATHIOPRINE BP FILM COATED TABLETS 50MG GENERICS (UK) LIMITED UNITED KINGDOM

AZATHIOPRINE PCH TABLET 50MG PHARMACHEMIE BV NETHERLANDS

AZATHIOPRINE TABLETS 50MG TABLETS 50MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

AZATHIOPRINE TABLETSBP 50MG

FILM COATED TABLETS 50MG GENERICS (UK) LIMITED UNITED KINGDOM

AZATRILEM TABLETS 50MG LEMERY S.A. MEXICO

AZEE, AZITHROMYCIN CAPSULESUSP

CAPSULES 250 MG CIPLA LTD. INDIA

AZELDERM CREAM 20%W/W KLEVA LIMITED GREECE

AZEPTIL 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

AZEPTIL 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS

AZEPTIL 500MG/5ML LIQUID FOR INJECTION 500MG/5ML MEDOCHEMIE LTD CYPRUS

AZITHROMYCIN CAPSULE 250MG PFIZER LIMITED UNITED KINGDOM

AZOPT OPHTHALMICSUSPENSION

10MG/ML ALCON LABORATORIESINC.

UNITED STATES OFAMERICA

AZOPT EYE DROPS SOLUTION 10MG/ML ALCON LABORATORIESUK LIMITED

EUROPEAN COMMUNITY

BABY MELTUS FOR BABIESCOUGHS

ORAL SOLUTION 0.42 ML CUPAL LIMITED UNITED KINGDOM

BACLOFEN TABLETS 10MG TABLET 10MG GENERICS (UK) LIMITED UNITED KINGDOM

BACLOFEN TABLETS 10MG TABLET 10MG GENERICS (UK) LIMITED UNITED KINGDOM

BACLOFEN TABLETS 10MG TABLETS 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

BACLON 10MG TABLET 10MG LEIRAS OY FINLAND

BACTROBAN OINTMENT 2% W/W BEECHAM GROUP PLC UNITED KINGDOM

BACTROBAN CREAM 2% W/W SMITHKLINE BEECHAMPHARMACEUTICALS

UNITED STATES OFAMERICA

BACTROBAN CREAM CREAM 2% W/W BEECHAM GROUP PLC UNITED KINGDOM

BACTROBAN NASAL OINTMENT2% W/W

NASAL OINTMENT 2% W/W BEECHAM GROUP PLC UNITED KINGDOM

BALANCED SALT SOLUTION(AKORN)

IRRIGATING SOLUTION N/A TAYLORPHARMACEUTICALS

UNITED STATES OFAMERICA

EL480 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BALKIS 0.05% NASAL DROPS SOLUTION 0.05% W/V DOLORGIET GMBH & CO.KG

GERMANY

BALKIS 0.1% NASAL DROPS SOLUTION 0.1% W/V DOLORGIET GMBH & CO.KG

GERMANY

BALKIS NASAL SPRAY SOLUTION 1MG/ML DOLORGIET GMBH & CO.KG

GERMANY

BALKIS NASAL SPRAY SOLUTION NASAL SPRAY 1MG/ML DOLORGIET GMBH & COKG

GERMANY

BALMOSA CREAM N/A PHARMAX LIMITED UNITED KINGDOM

BALTO FOOT BALM OINTMENT N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

BARILUX HD POWDER 96.805% W/W GOLDHAM PHARMAGMBH

GERMANY

BAYCUTEN N CREAM N/A BAYER VITAL GMBH &CO. AG

GERMANY

BAYCUTEN N CREAM N/A BAYER PAKISTAN

BAYCUTEN-N CREAM N/A BAYER PAKISTAN

BAYRO GEL GEL NA TROPON GMBH GERMANY

BAYROGEL GEL 50MG/G BAYER VITAL GMBH &CO. KG

GERMANY

BAZUKA EXTRA STRENGTH GEL GEL 26% W/W DIOMED DEVELOPMENTSLIMITED T/A DERMALLABORATORIES

UNITED KINGDOM

BAZUKA GEL GEL N/A DIOMED DEVELOPMENTSLIMITED T/A DERMALLABORATORIES

UNITED KINGDOM

BCG VACCINE INTRADERMAL BP FREEZE DIRED PREP. F/INJ.

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

BCG VACCINE INTRADERMAL BPISONIAZID RES

FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM

BCG VACCINE PERCUTANEOUS BP FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM

BCG VACCINE SSI POWDER FOR INJECTION 0.75MG/ML STATENS SERUMINSTITUT

DENMARK

BEBEGEL RECTAL GEL N/A ASTA MEDICA FRANCE

BECADRIL 500 CASULES 500MG REMEDICA LTD CYPRUS

BECEDRIL 1G TABLETS 1G REMEDICA LTD CYPRUS

BECEVIT S.C. TABLETS N/A REMEDICA LTD CYPRUS

BECEVIT TABLETS NA REMEDICA LTD. CYPRUS

BECLATE 250 INHALER INHALER 250MCG/ACTUATIOΝ

CIPLA LIMITED INDIA

BECLATE-50 INHALER 50MCG CIPLA LIMITED INDIA

BECLAZONE 100 INHALER 100MCG/DOSE NORTON HEALTHCARELIMITED

UNITED KINGDOM

BECLAZONE 100 CFC-FREE INHALER 100MCG/DOSE NORTON (WATERFORD) IRELAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 481

Trade Name Dosage Form Dose MA Holder Country

BECLAZONE 250 INHALER 250MCG/DOSE NORTON HEALTHCARELIMITED

UNITED KINGDOM

BECLAZONE 250 CFC-FREEINHALER

INHALER 250MCG/DOSE NORTON (WATERFORD) IRELAND

BECLAZONE 50 INHALER 50MCG/DOSE NORTON HEALTHCARELIMITED

UNITED KINGDOM

BECLAZONE 50 CFC-FREEINHALER

INHALER 50MCG/DOSE NORTON (WATERFORD) UNITED KINGDOM

BECLAZONE 50 EASI-BREATHECFC-FREE

INHALER 50MCG/DOSE NORTON (WATERFORD) IRELAND

BECLAZONE EASI-BREATHECFC-FREE

INHALER 250MCG/DOSE NORTON (WATERFORD) IRELAND

BECLOFORTE METERED AEROSOL N/A GLAXOWELLCOME PAKISTAN

BECLOFORTE INHALER AEROSOL 250 MCG/AC GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

BECLOFORTE INHALER AEROSOL 250MCG/DOSE GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

BECLOMETASONE DIPROPIONATE50MCG

AQUEOUS NASAL SPRAY 0.039%W/V ASHBOURNEPHARMACEUTICAL(HOLDINGS) LIMITED

UNITED KINGDOM

BECLOMETHASONEDIPROPIONATE

AQUEOUS NASAL SPRAY 50MCG/DOSE NORTON HEALTHCARELIMITED

UNITED KINGDOM

BECLOMETHASONEDIPROPIONATE AQ. NASAL SP

NASAL SPRAY 50MCG/ACTUATION GENERICS (UK) LIMITED UNITED KINGDOM

BECLOMIST NASAL SPRAY FORHAYFEVER

NASAL SPRAY 50MCG/ACTUATION PARKFIELDSPHARMACEUTICALSLIMITED

UNITED KINGDOM

BECONASE ALLERGY NASAL SPRAY 50MCG/AC GLAXO WELLCOME UKLTD T/A ALLEN &HANDURYS

UNITED KINGDOM

BECONASE AQUEOUS NASALSPRAY

NASAL SPRAY 50MCG/AC GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

BECONASE AQUEOUS NASALSPRAY

NASAL SPRAY 50UG/AC GLAXO WELLCOME UKLIMITED T/A ALLEN &HANDBURYS

UNITED KINGDOM

BECONASE AQUEOUS NASALSPRAY

NASAL SPRAYSUSPENSION

50MCG/DOSE ALLEN FARMACEUTICAS.A.

SPAIN

BECONASE HAYFEVER NASAL SPRAY 50MCG/AC GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

BECONASE HAYFEVER NASAL SPRAY 50UG/AC GLAXO WELLCOME UKLIMITED T/A ALLEN &HANDBURYS

UNITED KINGDOM

BECOTIDE AEROSOL F/INH. 50MCG/DOSE GLAXOWELLCOME PAKISTAN

BECOTIDE 100 INHALER AEROSOL 100MCG/AC GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

BECOTIDE 100 INHALER AEROSOL 100UG/AC GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

EL482 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BECOTIDE 50 INHALER AEROSOL 50MCG/AC GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

BECOTIDE 50 INHALER AEROSOL 50MCG/DOSE GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

BECOZYM FORTE SUGAR-COATED TABLET N/A ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

BEECHAM 75MG ASPIRINTABLETS

TABLET 75MG BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAM DAY NURSE ORAL SOLUTION N/A BEECHAM GROUP PLC UNITED KINGDOM

BEECHAMS ALL-IN-ONE ORAL SOLUTION N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS COLD AND FLU HOTBLACKCURRANT

POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS COLD AND FLU HOTLEMON

POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS COLD AND FLU HOTLEMON AND HONEY

POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS FLU-PLUS HOTLEMON

POWDER FOR ORALSOLUTION

NA BEECHAM GROUP PLC UNITED KINGDOM

BEECHAMS POWDER POWDER FOR ORALSOLUTION

NA BEECHAM GROUP PLCT/A GLAXOSMITHKLINECONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS THROAT-PLUSBLACKCURRANT

LOZENGES NA BEECHAM GROUP PLCT/A GLAXOSMITHKLINECONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS THROAT-PLUS LEMON LOZENGES NA BEECHAM GROUP PLCT/A GLAXOSMITHKLINECONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAM'S VENO'S COUGHMIXTURE

ORAL SOLUTION N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS VENO'SEXPECTORANT

ORAL SOLUTION N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS VENO'S HONEY ANDLEMON

ORAL SOLUTION N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 483

Trade Name Dosage Form Dose MA Holder Country

BEECHAMS WARMERSBLACKCURRANT

POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS WARMERS LEMON POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEECHAMS WARMERS LEMONAND HONEY

POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

BEGROCIT EFFERVESCENT TABLET N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

BELARAMINE EXPECTORANT SYRUP N/A REMEDICA LTD CYPRUS

BELL'S CHILDRENS COUGH SYRUP ORAL LIQUID 100MG/5ML BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

BELL'S WINTERGREEN OINTMENT OINTMENT N/A BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

BENADRYL ALLERGY RELIEF CAPSULE 8MG WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

BENDROFLUAZIDE TABLET 5MG CAMDEN INDUSTRIES (M)SDN.BHD

MALAYSIA

BENDROFLUAZIDE BP 5MG TABLET 5MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

BENDROFLUAZIDE TABLETSBP 5MG

TABLET 5MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

BENOXYL 5 LOTION / PANOXYL 5LOTION

TOPICAL EMULSION 5% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

BENT 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

BENXHEXOL 2 TABLETS TABLETS 2MG REMEDICA LTD CYPRUS

BENYLIN CHESTY COUGHS(NON-DROWSY)

SYRUP N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

BENYLIN CHESTY COUGHS(ORIGINAL)

SYRUP N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

BENYLIN CHILDREN'S CHESTYCOUGHS

SYRUP 50MG/5ML WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

BENYLIN CHILDREN'S NIGHTCOUGHS

SYRUP N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

BENYLIN CHILDREN'S NIGHTCOUGHS

SYRUP N/A PFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

BENYLIN DRY COUGHS (NONDROWSY)

SYRUP 7.5MG/5ML WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

EL484 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BENYLIN DRY COUGHS(ORIGINAL)

SYRUP N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

BENYLIN FOUR FLU LIQUID ORAL SOLUTION N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

BENYLIN FOUR FLU LIQUID ORAL SOLUTION N/A PFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

BENYLIN WITH CODEINE SYRUP N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

BENZAMYCIN GEL GEL N/A DERMIK LABORATORIESINC.

UNITED KINGDOM

BENZET LOZENGES NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

BENZHEXOL BP TABLET 2MG BIOREX LABORATORIESLTD.

UNITED KINGDOM

BENZOIN TINCTURE BP TOPICALSOLUTION

TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM

BENZYL BENZOATE APPLICATIONBP

TOPICAL EMULSION 25% W/V BELL SONS & CO(DRUGGISTS) LTD

UNITED KINGDOM

BENZYL BENZOATE APPLICATIONBP

TOPICAL EMULSION N/A THORNTON & ROSS UNITED KINGDOM

BEPANTHEN CREAM 50MG/G ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

BEPANTHEN LOTION 25MG/ML ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

BEPANTHEN ROCHE CREAM CREAM 50MG/G HOFFMAN-LA ROCHE AG GERMANY

BEPANTHEN ROCHE OINTMENT OINTMENT 50MG/G HOFFMAN-LA ROCHE AG GERMANY

BEPROGEL TOPICAL SOLUTION 0.5MG/ML HOE PHARMACEUTICALSSDN BHD

MALAYSIA

BEPROGEL TOPICAL SOLUTION N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

BEPROSONE CREAM 0.064% W/W HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

BERIATE P 1000. DRY SUBSTANCE ANDSOLVENT

N/A AVENTIS BEHRING GMBH GERMANY

BERMOXEL 600MG TABLET 600MG MEDOCHEMIE LTD CYPRUS

BEROCIL 4MG TABLET 4MG MEDOCHEMIE LTD CYPRUS

BEROTEC METERED AEROSOL 100MCG / PUFF BOEHRINGER INGELHEIMPHARMA KG

GERMANY

BETABIOPTAL EYE DROPS N/A FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

BETACORTEN SCALP APPLICATION 0.1%W/W TRIMA ISRAELPHARMACEUTICALPRODUCTS LIMITED

ISRAEL

BETADERM CRM 0.1%W/W CREAM 0.1% W/W TAROPHARMACEUTICALS INC

CANADA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 485

Trade Name Dosage Form Dose MA Holder Country

BETADERM ONT 0.1% W/W OINTMENT 0.1% W/W TAROPHARMACEUTICALS INC

CANADA

BETADINE ALCOHOLICSOLUTION 10%

SOLUTION 10% MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE ALCOHOLICSOLUTION 1O%

TOPICAL ALCOHOLICSOLUT.

10% W/V MUNDIPHARMAPHARMACEUTICALS LTD.

CYPRUS

BETADINE ANTISEPTIC PAINT 10% ANTISEPTIC PAINT 10%W/V MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE ANTISEPTIC SOLUTION SOLUTION 10% MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE ANTISEPTIC SOLUTION10%

ANTISEPTIC SOLUTION 10%W/V MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE CREAM CREAM 5%W/W MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE CREAM CREAM 5%W/W MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE DRY POWDER SPRAY2.5%

POWDER 2.5% W/W MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE GARGLE ANDMOUTHWASH

GARGLE 1%W/V MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE GARGLE ANDMOUTHWASH 1%

GARGLE 1%W/V MUNDIPHARMAPHARMACEUTICALS LTD.

CYPRUS

BETADINE OINTMENT 10% OINTMENT 10%W/W MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE OINTMENT 10% OINTMENT 10%W/W MUNDIPHARMAPHARMACEUTICALS LTD.

CYPRUS

BETADINE SCALP ANDSKINCLEANSER 7.5%

TOPICAL LIQUID SOAP 7.5%W/V MUNDIPHARMAPHARMACEUTICALS LTD.

CYPRUS

BETADINE SHAMPOO 4% SHAMPOO 4%W/V MUNDIPHARMAPHARMACEUTICALS LTD.

CYPRUS

BETADINE SKIN CLEANSER 4% TOPICAL LIQUID SOAP 4%W/V MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE SURGICAL SCRUB 7.5% TOPICAL LIQUID SOAP 7.5%W/V MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE VAGINAL DOUCHE10%

DOUCHE 10%W/V MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETADINE VAGINAL DOUCHE10%

DOUCHE 10%W/V MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BETAFERON POWDER FOR SOLN. FORINJ.

0.25MG/ML SCHERINGAKTIENGESELLSCHAFT

UNITED KINGDOM

BETAFERON POWDER AND SOLVENTF/SOLUTION F/INJECTION

0.25MG/ML SCHERINGAKTIENGESELLSCHAFT

EUROPEAN COMMUNITY

BETAGAN (LEVOBUNOLOL HCL)LIQUIFILM

TOPICAL OPHTHALMICSOLN.

0.5% W/V ALLERGANPHARMACEUTICALS(IRELAND) LTD., INC.

IRELAND

BETAHISTINE DIHYDROCHLORIDETABLETS 8MG

TABLET 8MG GENERICS (UK) LIMITED UNITED KINGDOM

BETAKSIM STERILE POWDER FORINJ.

1G MUSTAFA NEVZAT ILACSANAYII A.S.

TURKEY

EL486 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BETAMESOL CREAM 0.05% W/W PROGE FARM S.R.L. ITALY

BETAMESOL TUBO 30G CREMA0.05%

CREAM N/A PROGE FARM S.R.L ITALY

BETAMETHASONE CREAM0.1%W/W

CREAM 0.1% W/W SM PHARMACEUTICALSSDN.BHD.

MALAYSIA

BETAPLEX TABLET N/A CAMDEN INDUSTRIES (M)SDN. BHD.

MALAYSIA

BETAPYN TABLET N/A ADCOCK INGRAM LTD SOUTH AFRICA

BETASERC TABLET 8MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

BETASERC TABLET 16MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

BETASONE CREAM CREAM 0.1% W/W HOVID SDN. BHD. MALAYSIA

BETAVIX SYRUP SYRUP 7.5MG/5ML GENEPHARM S.A. GREECE

BETNESOL 0.50MG EFFERVESCENT TABLET 0.5MG GLAXO WELLCOME FRANCE

BETNOVATE CREAM 1MG/G GLAXO WELLCOME PAKISTAN

BETNOVATE OINTMENT 1MG/G GLAXO WELLCOME PAKISTAN

BETNOVATE C CREAM CREAM N/A GLAXO WELLCOME UKLTD T/A GLAXO LABS

UNITED KINGDOM

BETNOVATE C CREAM CREAM NA GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

BETNOVATE CREAM CREAM 0.122% W/W GLAXO WELLCOME UKLTD

UNITED KINGDOM

BETNOVATE CREAM CREAM 0.122%W/W GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

BETNOVATE N CREAM CREAM N/A GLAXO WELLCOME UKLTD T/A GLAXO LABS

UNITED KINGDOM

BETNOVATE N CREAM CREAM NA GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

BETNOVATE OINTMENT OINTMENT 0.122% W/W GLAXO WELLCOME LTDT/A GLAXO LABS

UNITED KINGDOM

BETNOVATE OINTMENT OINTMENT 0.1% W/W GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

BETNOVATE SCALP TOPICAL SOLUTION 0.1%W/W GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

BETNOVATE SCALP APPLICATION TOPICAL SOLUTION 0.122% W/W GLAXO WELLCOME UKLTD

UNITED KINGDOM

BETNOVATE SCALP APPLICATION SOLUTION FOR TOPICALUSE

0.122%W/W GLAXO WELLCOME UKLIMITED

GERMANY

BETNOVATE SCALP APPLICATION TOPICAL SOLUTION 0.1%W/W GLAXO LABORATORIESLIMITED

UNITED KINGDOM

BETOPTIC S/BETOPTICSUSPENSION

OPHTHALMICSUSPENSION

2.5MG/ML S.A. ALCON-COUVREURN.V.

BELGIUM

BETRISS TABLET N/A MEDOCHEMIE LTD CYPRUS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 487

Trade Name Dosage Form Dose MA Holder Country

BETTAMOUSSE CUTANEOUS FOAM 0.12%W/W MEDEVA PHARMALIMITED

UNITED KINGDOM

BEZALIP FILM COATED TABLET 200MG HOFFMANN-LA ROCHEAG

GERMANY

BEZALIP RETARD COATED SUSTAINEDREL. TAB

400MG HOFFMANN-LA ROCHE GERMANY

BI PRETERAX TABLET N/A LES LABORATOIRESSERVIER

FRANCE

BIAFINE EMLSION F/CUTANEOUSAPPL.

0.67G/100G LABORATOIRES MEDIX FRANCE

BIO 3 CAMOMILE TEA INFUSION BAG 1.5G BIODES, S.L. SPAIN

BIO 3 HERBAL TEA INFUSION BAG 1.5G BIODES, S.L. SPAIN

BIO 3 OBESIDAD-OBESITY CAPSULES 500MG BIODES, S.L. SPAIN

BIO 3 POWDER FOR ORALRECONSTITUTION

POWDER N/A BIODES S.L. SPAIN

BIO 3 WEIGHT CONTROL INFUSION BAG N/A BIODES, S.L. SPAIN

BIOCADMIO SUSPENSION CUTANEOUSSUSPENSION

1G/100ML J.URIACH & CIA. S.A. SPAIN

BIOCALYPTOL WITHPHOLCODINE

SYRUP N/A LABORATORIES LAPHAL FRANCE

BIOCARBON TABLETS NA F.TRENKA CHEMISCH-PHARMAZEUTISCHEFABRIK GMBH

AUSTRIA

BIOCINE TEST PPD INTRADER. MULTIPUNC.TEST

N/A CHIRON S.P.A. ITALY

BIODRAMINA CHEWING-GUM 20MG J.URIACH & CIA. S.A. SPAIN

BIODRAMINA TABLET 50MG J.URIACH & CIA. S.A. SPAIN

BIODRAMINA INFANTILE SUPPOSITORY 50MG J.URIACH & CIA. S.A. SPAIN

BIOELECTRA CALCIUM 500 EFFERVESCENT TABLETS 500MG HERMES ARZNEMEITTELGMBH

GERMANY

BIOFERON 1 M.I.U FREEZE DRIED PWR FORINJ

1000000 IU INSTITUTO SIDUS S.A. ARGENTINA

BIOFERON 10 M.I.U. FREEZE DRIED PWR FORINJ

10000000 IU INSTITUTO SIDUS S.A. ARGENTINA

BIOFERON 3 M.I.U FREEZE DRIED PWD FORINJ

3000000 IU INSTITUTO SIDUS S.A ARGENTINA

BIOFERON 5 M.I.U FREEZE DRIED PWD FORINJ

5000000 IU INSTITUTO SIDUS S.A ARGENTINA

BIOFLOR CAPSULES 250MG BIOMED AG SWITZERLAND

BIOFLOR POWDER FOR ORALSUSP.

250MG/SACHET BIOMED AG SWITZERLAND

BIOLECTRA CALCIUM 500 EFFERVESCENT TABLET 500MG HERMES ARZNEIMITTELGMBH

GERMANY

BIOPLUS EFFERVESCENT TABLETS TABLETS N/A ADCOCK INGRAM LTD SOUTH AFRICA

EL488 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BIORAL GEL OROMUCOSAL GEL 2% W/W SEVEN SEAS LIMITED T/AMERCK CONSUMERHEALTH

UNITED KINGDOM

BIORINIL NASAL SPRAY,SUSPENSION

N/A FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

BIOSELENIUM SUSPENSION CUTANEOUSSUSPENSION

2.5G/100ML J.URIACH & CIA. S.A. SPAIN

BIO-STAR CAPSULES 80MG LABORATORIOS NOVAG,S.A.

SPAIN

BIO-STAR VIALS ORAL SOLUTION N/A LABORATORIOS NOVAG,S.A.

SPAIN

BIOTONE ORAL SOLN IN AMPOULE N/A LABORATORIES LAPHAL FRANCE

BIPROFENID 150MG TABLET 150MG SPECIA LABORATORIES FRANCE

BISACODYL TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

BISACODYL BP 5MG TABLET 5MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

BISACODYL SUPPOSITORIESBP 10MG

SUPPOSITORY 10MG MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

BISACODYL TABLET 5MG TABLET 5MG CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

BISACODYL TABLET B.P. 5MG TABLET 5MG PHARMMALAYSIABERHAD

MALAYSIA

BISACODYL TABLETS 5MG TABLET 5MG GEOFMANPHARMACEUTICALS

PAKISTAN

BISMUTH SUBNITRATE ANDIODOFORM PASTE

IMPREGNATED GAUZE N/A AURUMPHARMACEUTICALSLIMITED

UNITED KINGDOM

BISODOL HEARTBURN RELIEFTABLETS

TABLETS N/A WHITEHALLLABORATORIES LTD

UNITED KINGDOM

BISODOL INDIGESTION RELIEFTABLETS

TABLETS N/A WHITEHALLLABORATORIES LTD

UNITED KINGDOM

BISODOL TABLETS TABLETS N/A WHITEHALLLABORATORIES LTD

UNITED KINGDOM

BISOLAX 10MG SUPPOSITORY 10MG MEDOCHEMIE LTD CYPRUS

BISOLAX 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

BISOLVON SOLUTION 0.2G/100ML BOEHRINGER INGELHEIMPHARMA KG

GERMANY

BISOLVON SOLUTION FORINJECTION

8MG/4ML BOEHRINGER INGELHEIMPHARMA KG

GERMANY

BISOLVON SYRUP 0.08G/100ML BOEHRINGER INGELHEIMPHARMA KG

GERMANY

BISOLVON TABLETS 8MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

BISOLVON TABLETS 8MG BOEHRINGER INGELHEIM PAKISTAN

BI-TILDIEM SR 120MG SR COATED TABLET 120MG LABORATOIRESSYNTHELABO

FRANCE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 489

Trade Name Dosage Form Dose MA Holder Country

BI-TILDIEM SR 90MG SR COATED TABLET 90MG LABORATOIRESSYNTHELABO

FRANCE

BLEO-KYOWA POWDER FOR INJECTION 15,000IU KYOWA HAKKO (UK)LTD

UNITED KINGDOM

BLEOLEM POWDER FORINJECTIONS

15.00U/5ML LEMERY, S.A. DE C.V. MEXICO

BLEOLEM POWDER FOR INJECTION 15U/5ML LEMERY S.A. DE C.V. MEXICO

BLISTEX RELIEF CREAM CREAM NA DDD LIMITED UNITED KINGDOM

BLISTEZE CREAM CREAM N/A D D D LIMITED UNITED KINGDOM

BLITZ 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

BLOPRESID 16/12.5MG TABLETS TABLETS NA TAKEDA ITALIAFARMACEUTICI S.P.A —ITALY

ITALY

BLOPRESS TABLET 4MG TAKEDA ITALIAFARMACEUTICI S.P.A.

ITALY

BLOPRESS TABLET 8MG TAKEDA ITALIAFARMACEUTICI S.P.A.

ITALY

BLOPRESS TABLET 16MG TAKEDA ITALIAFARMACEUTICI S.P.A.

ITALY

BONDIL URETHRAL STICK 125MCG VIVUS UK UNITED KINGDOM

BONDIL URETHRAL STICK 250MCG VIVUS UK UNITED KINGDOM

BONDIL URETHRAL STICK 500MCG VIVUS UK UNITED KINGDOM

BONDIL URETHRAL STICK 1000MCG VIVUS UK UNITED KINGDOM

BONEFOS 400MG CAPSULE 400MG LEIRAS OY FINLAND

BONEFOS 60MG/ML CONC. FOR PARENT.INFUS.

60MG/ML LEIRAS OY FINLAND

BONIDON GEL 10MG/G MEPHA PHARMA AG SWITZERLAND

BONJELA GEL N/A RECKITT & COLMAN PAKISTAN

BONJELA OROMUCOSAL GEL N/A LLOYD'SPHARMACEUTICALSLIMITED T/A RECKITT &COLMAN PRODUCT

UNITED KINGDOM

BOOTS NIROLEX LOZENGES LOZENGE 2.5MG THE BOOTS COMPANYPLC

UNITED KINGDOM

BORADRINE EYE DROPS NA BOURNONVILLEPHARMA

BELGIUM

BOROCAINA LOZENGE N/A ALFA WASSERMANNS.P.A.

ITALY

BOROCAINA GOLA TABLETS 1.5MG ALFA WASSERMANNS.P.A.

ITALY

BOROCAINA GOLA TABLET 1.5MG ALFA WASSERMANNS.P.A.

ITALY

BOROCAINA GOLA TABLET 1.5MG ALFA WASSERMANNS.P.A.

ITALY

EL490 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BOTOX POWDER SOLNINJECTION

100 UNITS ALLERGAN SALES LTD IRELAND

BOTOX POWDER F/SOLN F/INJ 100UNITS/VIAL ALLERGANPHARMACEUTICALS(IRELAND) LIMITED

IRELAND

BOTULISM ANTIOXIN BEHRING SOL. FOR INFUSION ANDINJEC

N/A CHIRON BEHRING GMBH& CO

GERMANY

BOZAKTRAL TABLETS 10MG CHRISPA ALFAFARMAKEYTICI S.A.

GREECE

BRADOSOL PLUS LOZENGE N/A NOVARTIS COMSUMERHEALTH UK LIMITED

UNITED KINGDOM

BRADOSOL SUGAR FREE CHERRYMENTHOL

LOZENGES 0.04% V/W NOVARTIS CONSUMERHEALTH UK LIMITED

UNITED KINGDOM

BRADOSOL SUGAR FREEORIGINAL CITRUS

LOZENGE 0.04% V/W NOVARTIS CONSUMERHEALTH UK LIMITED

UNITED KINGDOM

BRASIVOL FINE CREAM 38% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

BRASIVOL MEDIUM CREAM 52% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

BRAUNOL 2000 SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

BRETYLATE SOLUTION FORINJECTION

100MG/2ML WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

BRETYLIUM INJ MINIJET AQUEOUS SOLUTION 50MG/ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

BRETYLIUM TOSYLATE INJECTIONMINIJET

SOLUTION FORINJECTION

50MG/ML INTERNATIONALMEDICATION SYSTEMS(UK) LTD

UNITED KINGDOM

BRETYLIUM TOSYLATE MINIJET SOLUTION FORINJECTION

50MG/ML INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

BREVIBLOC SOLUTION FOR IVINFUSION

250MG/ML BAXTERPHARMACEUTICLPRODUCTS

UNITED STATES OFAMERICA

BREVIBLOC INJECTION SOLUTION FOR IVINFUSION

10MG/ML BAXTERPHARMACEUTICALPRODUCTS

UNITED STATES OFAMERICA

BREVOXYL CREAM 4% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

BRICANYL TABLETS 2.5MG DRACO LAKEMEDEL AB SWEDEN

BRICANYL TURBUHALER INHALATION POWDER 0.5MG/DOSE DRACO LAKEMEDEL AB SWEDEN

BRINERDIN SUGAR COATEDTABLETS

N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

BRINERDINA FILM COATED TABLETS NA NOVARTIS FARMA SPA ITALY

BROMHEXINE 8 TABLETS 8MG REMEDICA LTD CYPRUS

BROMHEXINE SYRUP ORAL SOLUTION 4MG/5ML CAMDEN INDUSTRIES (M)SDN. BHD.

MALAYSIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 491

Trade Name Dosage Form Dose MA Holder Country

BROMHEXINE SYRUP 4MG/5ML SYRUP 4MG/5ML CAMDEN INDUSTRIES (M)SDN. BHD

MALAYSIA

BROMHEXIN-RATIOPHARM SAFT SOLUTION 4MG/5ML RATIOPHARM GMBH GERMANY

BROMOCRIPTINE TABLETS 2.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

BRONCALENE ADULTS SYRUP N/A LABORATOIRES MARTIN-JOHNSON & JOHNSON-MSD

FRANCE

BRONCALENE CHILDREN SYRUP 0.01G/100ML LABORATOIRES MARTIN FRANCE

BRONCALENE INFANT SYRUP N/A LABORATOIRES MARTIN FRANCE

BRONCATHIOL 2% CHILDRENAND INFANTS

SYRUP 2% W/V LABORATOIRES MARTIN FRANCE

BRONCATHIOL ADULTEXPECTORANT

ORAL SOLUTION 5G/100ML LABORATOIRES MARTIN-JOHNSON & JOHNSON-MSD

FRANCE

BRONCHOPED SYRUP N/A ADCOCK INGRAM LTD SOUTH AFRICA

BRONCHOPRONT CAPSULE WITH SUST.ACTION

75MG HEINRICH MACK NACHF GERMANY

BRONCHOPRONT SYRUP 0.3G/100ML HEINRICH MACK NACHF GERMANY

BRONCHOTUSSINE SYRUP 4MG/5ML ADELCO-CHROMATOURGIAATHINON E.COLOCOTRONIS BROSS.A.

GREECE

BRONCHO-VAXOM ADULTS CAPSULE 40MG OM PHARMA SWITZERLAND

BRONCHO-VAXOM CHILDREN CAPSULE 20MG OM PHARMA SWITZERLAND

BRONCOFLUID ORAL SUSPENSION N/A PHARMARECORD S.R.L. ITALY

BRONCOLIN TABLETS 4MG TABLET 4MG GEOFMANPHARMACEUTICALS

PAKISTAN

BRONQUIMUCIL CAPSULE N/A J.URIACH & CIA., S.A. SPAIN

BRONQUIMUCIL SUSPENSION ORAL SUSPENSION N/A J.URIACH & CIA. S.A. SPAIN

BROT 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

BRUFEN TABLET 400MG KNOLL PAKISTAN

BRULIDINE CREAM 0.15% W/W MANX PHARMA LIMITED UNITED KINGDOM

BRUMETIDINA SOLUTION FOR IMINJECTION

200MG/2ML BRUSCHETTINI SRL ITALY

BRUXICAM DERMATOLOGICALCREAM

1% W/W BRUSCHETTINI SRL ITALY

BRUXICAM CAPSULE 20MG BRUSCHETTINI SRL ITALY

BRUXICAM SUPPOSITORY 20MG BRUSCHETTINI SRL ITALY

BSS 15ML/BSS ALCON INTRAOCULAR IRRIG.SOLN.

N/A S.A. ALCON-COUVREURN.V.

BELGIUM

BSS PLUS INTRAOCULAR IRRIGAT.SOLN

NO ACTIVE ING. ALCON LABORATORIESINC.

UNITED STATES OFAMERICA

EL492 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BSS PLUS 250ML AND 500ML/BSSPLUS ALCON

INTRAOCULAR IRRIG.SOLN.

N/A S.A. ALCON-COUVREURN.V.

BELGIUM

BUCCALIN BERNA TABLETS N/A SWISS SERUM ANDVACCINE INSTITUTE

SWITZERLAND

BUCCASTEM BUCCAL TABLETS 3MG RECKITT BENCKISERHEALTHCARE (UK)LIMITED

UNITED KINGDOM

BUDECORT RESPULES 0.25MG CIPLA LTD. INDIA

BUDECORT 0.5MG RESPULES 0.5MG/2ML CIPLA LIMITED INDIA

BUDECORT RESPULES 0.5MG/ML RESPIRATORSUSPENSION

1MG/2ML CIPLA LIMITED INDIA

BUDECORT-100 INHALER 100MCG CIPLA LIMITED INDIA

BUDECORT-200 INHALER 200MCG CIPLA LIMITED INDIA

BUDECORT-200 INHALER 200MCG/AC M/S CIPLA LIMITED INDIA

BUDENOFALK CAPSULES 3MG DR. FALK PHARMAGMBH

GERMANY

BUDESPRAY — 200 INHALER AEROSOL CANISTER 200 MCG M/S MEDISPRAYLABORATORIES PVT. LTD— GOA

INDIA

BUMETANIDE TABLETS 5MG REMEDICA LTD. CYPRUS

BUMETANIDE TABLETS 1MG REMEDICA LTD. CYPRUS

BUPIVACAINE ADRENALINEMERCK

SOLUTION FORINJECTION

100MG/20ML MERCK GENERICS FRANCE

BUPIVACAINE HCL INJECTION,USP

SOLUTION FORINJECTION

0.25% W/V ABBOTT LABORATORIES UNITED STATES OFAMERICA

BUPIVACAINE HCL INJECTION,USP 0.5%

SOLUTION FORINJECTION

0.5% W/V ABBOTT LABORATORIES UNITED STATES OFAMERICA

BUPIVACAINE MERCK 0.5% SOLUTION FOR INJ. 100MG/20ML MERCK GENERIQUES FRANCE

BURINEX TABLETS 5MG LEO PHARMACEUTICALPRODUCTS

DENMARK

BURINEX TABLETS 1MG LEO PHARMACEUTICALPRODUCTS

DENMARK

BURINEX SOLUTION FORINJECTION

0.5MG/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

BURINEX A TABLETS N/A LEO PHARMACEUTICALPRODUCTS

DENMARK

BURINEX K TABLETS N/A LEO PHARMACEUTICALPRODUCTS

DENMARK

BURINEX-K TABLETS TABLETS NA LEO PAKISTAN

BURNEZE SPRAY 1% W/W MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

BUSCOPAN SUGAR COATEDTABLETS

10MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

BUSCOPAN SUGAR COATED TABLET 10MG BOEHRINGER-INGELHEIM PAKISTAN

BUSCOPAN PLUS TABLETS NA BOEHRINGER INGELHEIM PAKISTAN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 493

Trade Name Dosage Form Dose MA Holder Country

BUSCOPAN TABLETS TABLETS 10MG BOEHRINGER INGELHEIM PAKISTAN

BUSPAR TABLETS 10MG BRISTOL MYERS SQUIBBAUSTRALIA PTY LTD

AUSTRALIA

BUSPAR TABLETS 5MG BRISTOL-MYERS SQUIBBCOMPANY

UNITED STATES OFAMERICA

BUSPAR TABLETS 10MG BRISTOL-MYERS SQUIBBCOMPANY

UNITED STATES OFAMERICA

BUTIRAN SYRUP N/A FARMACEUTICI ECOBIS.A.S

ITALY

BY-VERTIN TABLETS 8MG ERGHA HEALTHCARELIMITED

IRELAND

C1 ESTERASE INHIBITOR TIM 3 POWDER FOR INJECTION 1000PU/20ML OSTERREICHISCHESINSTITUT FURHAEMODERIVATEGES.M.B.H.

AUSTRIA

CA LAC TABLET 300MG RAZA MANUFACTURINGBERHARD

MALAYSIA

CABASER TABLETS 2MG PHARMACIA ITALIAS.P.A.

ITALY

CABASER TABLET 1MG PHARMACIA ITALIAS.P.A.

ITALY

CABASER TABLET 4MG PHARMACIA ITALIA S.P.A ITALY

CABASER TABLETS 1MG PHARMACIA ITALIA SPA ITALY

CABASER TABLETS 2MG PHARMACIA ITALIA SPA ITALY

CAC 1000 EFFERVESCENT TABLET N/A NOVARTIS PAKISTAN

CAC 1000 EFFERVESCENT TABLET NA NOVARTIS PAKISTAN

CA-C 1000 SANDOZ ORANGE EFFERVESCENT TABLETS N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

CAFLAM TABLET 50MG NOVARTIS PAKISTAN

CALADRYL LOTION TOPICAL SUSPENSION N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

CALAMINE LOTION B.P. TOPICAL SUSPENSION N/A WILLIAM RANSOM &SON PLC

UNITED KINGDOM

CALAMINE LOTION BP TOPICAL SUSPENSION N/A BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

CALAMINE LOTION BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM

CALAMINE LOTION BP LOTION N/A PINEWOOD LABS T/APINEWOODHEALTHCARE

IRELAND

CALAMINE LOTION BP TOPICAL SOLUTION N/A LCM UK UNITED KINGDOM

CALC. FLUOR. NEW ERABIOCHEMIC NO.1

TISSUE SALT NO1TABLET

NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

CALC. PHOS. NEW ERA NO.2CALC. PHOS.

TISSUE SALT TABLETSNO.2

NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

CALC. SULPH. 6X NEW ERABIOCHEMIC NO.3

TISSUE SALTS NO.3 NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

EL494 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CALCICARD CR TABLETS 90MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CALCICARD CR TABLETS 120MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CALCICHEW 500MG TABLETS TABLET 500MG SHIREPHARMACEUTICALSLIMITED

UNITED KINGDOM

CALCICHEW D3 FORTE TABLET N/A SHIREPHARMACEUTICALSLIMITED

UNITED KINGDOM

CALCIFEROL OIL FOR INJECTION 35UNITS/1ML EVANS MEDICAL LIMITED UNITED KINGDOM

CALCIFEROL INJECTION BP OIL FOR INJECTION 6(5) UNITS/2ML EVANS MEDICAL LIMITED UNITED KINGDOM

CALCIO 300 TABLET 300MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

CALCIPEN TABLETS 670MG LEO PHARMACEUTICALPRODUCTS

DENMARK

CALCITONIN NOVARTIS SOLUTION FORINJECTION

100IU NOVARTIS PHARMAGMBH

AUSTRIA

CALCIUM — SANDOZ F EFFERVESCENT TABLETS N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

CALCIUM 500 WITH D TABLETS N/A AEGIS LTD. CYPRUS

CALCIUM CHLORIDE INJECTIONMINIJET

SOLUTION FORINJECTION

10%W/V INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

CALCIUM CHLORIDE INJECTIONMINIJET

AQUEOUS INJECTION 10% W/V INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

CALCIUM GLUCONATE INJECTION SOLUTION FORINJECTION

1G/10ML F.H. FAULDING AND CO.LTD (T/A DAVID BULLLABS)

AUSTRALIA

CALCIUM GLUCONATE INJECTIONBP

SOLUTION FORINJECTION

89MG/10ML EVANS MEDICAL LIMITED UNITED KINGDOM

CALCIUM LACTATE TABLETS 300MG PHARMAMED LTD. MALTA

CALCIUM LACTATE 300 TABLETS 300MG REMEDICA LTD CYPRUS

CALCIUM LACTATE BP 300MG TABLET 300MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

CALCIUM LEUCOVORIN TABLETS 15MG CYANAMID OF GREATBRITAIN LTD. T/ALEDERLE LABS.

UNITED KINGDOM

CALCIUM LEUCOVORIN TABLETS 15MG CYANAMID OF GREATBRITAIN LTD

UNITED KINGDOM

CALCIUM RESONIUM ORAL POWDER 99.934%W/W SANOFI WINTHROPLIMITED

UNITED KINGDOM

CALCIUM SANDOZ EFFERVESCENT TABLET N/A SANDOZ PAKISTAN

CALGEL TEETHING GEL GINGIVAL GEL N/A GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 495

Trade Name Dosage Form Dose MA Holder Country

CALIMAL TABLET 4MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

CALLIMON EFFERVESCENT TABLET N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

CALM LIFE COATED TABLETS NA THE HERBAL RESEARCHCOMPANY LIMITED

UNITED KINGDOM

CALMPOSE 5MG TABLETS TABLETS 5MG RANBAXYLABORATORIES LTD.

INDIA

CALMURID CREAM N/A GALDERMA (UK) LIMITED UNITED KINGDOM

CALMURID HC CREAM N/A GALDERMA (UK) LIMITED UNITED KINGDOM

CALPOL 6+ SUSPENSION ORAL SUSPENSION 250MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

CALPOL INFANT SUSPENSION ORAL SUSPENSION 120MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

CALPOL SIX-PLUS SUSPENSION ORAL SUSPENSION 250MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

CALPOL SUGAR FREE INFANTSUSPENSION

ORAL SUSPENSION 120MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

CALPOL SUGAR FREE INFANTSUSPENSION

ORAL SUSPENSION 120MG/5ML GLAXO WELLCOME UKLIMITED

GERMANY

CALSALETTES (SUGAR COATED)TABLETS

COATED TABLET 38MG TORBET LABORATORIESLIMITED

UNITED KINGDOM

CAMCOLIT 250 TABLETS 250MG NORGINE LIMITED UNITED KINGDOM

CAMCOLIT 400 TABLETS 400MG NORGINE LIMITED UNITED KINGDOM

CAMCOLIT 400MG TABLET 400MG BIOPHARMA PAKISTAN

CAMNOVATE CREAM CREAM 0.1% W/W CAMDEN INDUSTRIES (M)SDN.BHD

MALAYSIA

CAMPTO 100MG/5ML CONCENTRATE FORINFUSION

100MG/5ML MAY & BAKER LIMITED UNITED KINGDOM

CAMPTO 40MG/2ML CONCENTRATE FORINFUSION

20MG/ML MAY & BAKER LIMITED UNITED KINGDOM

CANDACORT CREAM N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

CANDACORT CREAM N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

CANDACORT CREAM CREAM N/A HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

CANDAZOLE CREAM 1% W/W HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

CANDAZOLE CREAM 1%W/W HOE PHARMACEUTICALSSDN BHD

MALAYSIA

CANDAZOLE LOTION 1% W/V HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

CANDAZOLE LOTION LOTION 1% W/V HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

CANDIPLAS CREAM 2%W/W MEDOCHEMIE LTD CYPRUS

EL496 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CANESTEN CREAM 1G/100G BAYER VITAL GMBH &CO. KG

GERMANY

CANESTEN VAGINAL TABLET 500MG BAYER PAKISTAN

CANESTEN VAGINAL TABLET 500MG BAYER PAKISTAN

CANESTEN CREAM 0.01G/G BAYER PAKISTAN

CANESTEN CREAM 1% W/W BAYER PAKISTAN

CANESTEN VAGINAL TABLET 100MG BAYER PAKISTAN(PVT)LTD.

PAKISTAN

CANESTEN 1 10% CREAM VAGINAL CREAM 10%W/W BAYER VITAL GMBH GERMANY

CANESTEN 1% SOLUTION 1G/100ML BAYER VITAL GMBH &CO. KG

GERMANY

CANESTEN 10% VC (POM) VAGINAL CREAM 10% W/W BAYER PLC T/ACONSUMER CAREDIVISION

UNITED KINGDOM

CANESTEN COMBI VAGINAL CREAM ANDPESSARY

N/A BAYER PLC T/ACONSUMER CAREDIVISION

UNITED KINGDOM

CANESTEN DERMATOLOGICALSPRAY

TOPICAL SOLUTION 1% W/V BAYER PLC UNITED KINGDOM

CANESTEN HC CREAM 1% CREAM N/A BAYER PLC UNITED KINGDOM

CANESTEN HYDROCORTISONE CREAM N/A BAYER PLC T/ACONSUMER CAREDIVISION

UNITED KINGDOM

CANESTEN OASIS EFFERVESCENT POWDER N/A BAYER PLC UNITED KINGDOM

CANESTEN VAGINAL TABLETS VAGINAL TABLETS 100MG BAYER PAKISTAN

CANUSAL SOLUTION FORINJECTION

100IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

CANUSAL(HEPARIN SODIUM100U/ML)

SOLUTION FORINJECTION

100IU / ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

CAPACE TABLETS 25MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

CAPACE TABLETS 12.5MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

CAPOCARD TABLETS 50MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

CAPOCARD TABLETS 25MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

CAPOTEN TABLETS 12.5MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CAPOTEN TABLETS 25MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CAPOTEN TABLETS 50MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CAPOZIDE TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

CAPRIN ENTERIC COATEDTABLETS

75MG SINCLAIRPHARMACEUTICALSLIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 497

Trade Name Dosage Form Dose MA Holder Country

CAPTIL TABLET25MG(CAPTOPRIL)

TABLET 25MG UNIMEDPHARMACEUTICALS INC.

KOREA REPUBLIC

CAPTIL TABLET 50MG(CAPTOPRIL)

TABLET 50MG UNIMEDPHARMACEUTICALS INC.

KOREA REPUBLIC

CAPTOPRIL TABLETS 50MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

CAPTOPRIL TABLETS 25MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

CAPTOPRIL TABLETS 12.5MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

CAPTOPRIL TABLETS 12.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CAPTOPRIL TABLETS 25MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CAPTOPRIL TABLETS 50MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CAPTOPRIL DENK 25 TABLETS 25MG E. DENK OHG GERMANY

CAPTOPRIL TABLETS 25MG TABLET 25MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

CAPTOPRIL TABLETS 50MG TABLET 50MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

CAPTOPRIL TABLETS BP 25MG TABLET 25MG WAYMADE PLC UNITED KINGDOM

CARBACHOL TABLETS 2MG NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

CARBAMAZEPINE TABLETS 100MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CARBAMAZEPINE TABLETS 200MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CARBAMAZEPINE TABLETS 400MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CARBATOL TABLETS 200MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

CARBATOL TABLETS 200MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

CARBELLON TABLETS TABLET N/A TORBET LABORATORIESLIMITED

UNITED KINGDOM

CARBIMAZOLE TABLET 5MG CAMDEN INDUSTRIES (M)SDN. BHD.

MALAYSIA

CARBIROID TABLET 5MG TABLET 5MG HOVID SDN BHD MALAYSIA

CARBOPLATIN SOLUTION FORINJECTION

150MG/15ML PHARMACIA & UPJOHN(PERTH) PTY LTD.

AUSTRALIA

CARBOPLATIN INJECTIONSOLUTION

SOLUTION FORINJECTION

10MG/ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

CARBOPLATIN INJECTION VIAL SOLUTION FORINJECTION

50MG/5ML F.H. FAULDING & CO.LTD. (T/A DAVID BULLLABS)

AUSTRALIA

EL498 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CARBOPLATIN INJECTION VIAL SOLUTION FORINJECTION

450MG/5ML F.H. FAULDING & CO.LTD (T/A DAVID BULLLABS)

AUSTRALIA

CARBOPLATINO SOLUTION FORINJECTION

150MG/15ML PHARMACIA ITALIA SPA ITALY

CARBOSAN GEL 2% W/W ROWAPHARMACEUTICALS LTD

IRELAND

CARBOSIN SOLUTION FORINJECTION

10MG/ML PHARMACHEMIE BV NETHERLANDS

CARBOTINOL SOLUTION FORINJECTION

150MG KOREA UNITED PHARM.INC.

KOREA REPUBLIC

CARDIFEN-10 CAPSULES 10MG PHARMACARE LIMITED REPUBLIC OF SOUTHAFRICA

CARDILATE MR TABLETS 20MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CARDILATE MR 10MG TABLETS TABLETS 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CARDIOLITE DRY SUBSTANCE FOR IVINF

NA DUPONT PHARMA GMBH GERMANY

CARDIPRIL TABLETS 4.6MG BIALPORT PRODUCTOSFARMACEUTICOS SA

PORTUGAL

CARDIPRIL TABLETS 9.2MG BIALPORT — PRODUTOSFARMACEUTICOS SA

PORTUGAL

CARDURA TABLET 2MG PFIZER LIMITED UNITED KINGDOM

CARDURA TABLET 4MG PFIZER LIMITED UNITED KINGDOM

CARDURA TABLET 1MG PFIZER LIMITED UNITED KINGDOM

CARDURA XL MODIFIED RELEASETABLET

4MG PFIZER LTD. UNITED KINGDOM

CARDURA XL MODIFIED RELEASETABLET

8MG PFIZER LTD. UNITED KINGDOM

CARGOSIL CREAM 5% GENEPHARM S.A. GREECE

CARLOC-6.25 TABLETS 6.25MG CIPLA INDIA

CARTERON 5MG CAPSULE 5MG MEDOCHEMIE LTD CYPRUS

CASACOL LIQUID NA HELSINN BIREXPHARMACEUTICALSLIMITED

IRELAND

CASCADE (FORMELY NATEXNO. 1)TABLETS

COATED TABLET N/A MODERN HEALTHPRODUCTS LTD

UNITED KINGDOM

CASODEX 150MG COATED TABLET 150MG ZENECA LIMITED UNITED KINGDOM

CASODEX TABLETS 50MG COATED TABLET 50MG ZENECA LIMITED UNITED KINGDOM

CASPOFUNGIN MSD POWD F/CONC F/SOLN F/INF

50MG/VIAL MERCK SHARP ANDDOHME LIMITED

EUROPEAN COMMUNITY

CASPOFUNGIN MSD POWD. F/CONC F/SOLNF/INF

70MG/VIAL MERCK SHARP & DOHMELIMITED

UNITED KINGDOM

CASPOFUNGIN MSD POWDER FOR SOLUTIONFOR INFUSION

50MG/VIAL MERCK SHARP & DOHMELIMITED

EUROPEAN COMMUNITY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 499

Trade Name Dosage Form Dose MA Holder Country

CASTOR OIL BP ORAL SOLUTION N/A LCM LTD UNITED KINGDOM

CASTOR OIL BP ORAL SOLUTION 5ML LCM LTD UNITED KINGDOM

CATAFLAM SUGAR COATEDTABLETS

50MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

CATAFLAM TABLET 50MG GEIGY PAKISTAN

CATAFLAM SUGAR COATEDTABLETS

25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

CATAFLAM SUGAR COATEDTABLETS

50MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

CATAFLAM 1.5% DROPS 15MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

CATAFLAM RAPID COATED TABLETS 25MG NOVARTISPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

CATAFLAM RAPID COATED TABLETS 50 MG NOVARTISPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

CATHAY RISING SUN/GERARDGINGER/GINGER

TABLET 180MG CATHAY OFBOURNEMOUTH LTD T/AGERARD HOUSE

UNITED KINGDOM

CAVERIL TABLETS 40MG REMEDICA LTD CYPRUS

CAVERIL 40 TABLETS 40MG REMEDICA LTD CYPRUS

CAVERJECT POWDER FOR INJECTION 20MCG/ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

C-D-CALCIUM CHEWING TABLETS N/A G.STREULI & CO. AG SWITZERLAND

C-D-CALCIUM EFFERVESCENT TABLET N/A G.STREULI & CO. AG SWITZERLAND

CEALB (ALBUMIN 20 %) SOLUTION FORINFUSION

200G/L SANQUIN, CLB,PRODUCTS DIVISION

NETHERLANDS

CEALB (ALBUMIN 20%) SOL. FOR INFUSION 200G/L CLB NETHERLANDS

CEANEL CONCENTRATE TOPICAL SOLUTION N/A QUINODERM LIMITED UNITED KINGDOM

CECENU CAPSULES 40MG MEDAC GMBH GERMANY

CECLOR MODIFIED RELEASETABLET

375MG ELI LILLY ITALIA S.P.A. ITALY

CECLOR MODIFIED RELEASETABLET

500MG ELI LILLY ITALIA S.P.A. ITALY

CECLOR MODIFIED RELEASETABLET

750MG ELI LILLY ITALIA S.P.A. ITALY

CECLOR GRANULES FOR ORALSUSPEN.

125MG/5ML ELI LILLY ITALIA S.P.A. ITALY

CECLOR GRANULES FOR ORALSUSPEN.

5% W/V ELI LILLY ITALIA S.P.A. ITALY

CECLOR CAPSULES 500MG LILLY PAKISTAN

CECLOR MR TABLET 750MG LILLY PAKISTAN

CECLOR MR TABLET 375MG LILLY PAKISTAN

EL500 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CEFACET TABLETS 500MG LABORATOIRESNORGINE PHARMA

FRANCE

CEFACET TABLETS 1G LABORATOIRESNORGINE PHARMA

FRANCE

CEFACET GRANULES IN SACHETS 250MG LABORATOIRESNORGINE PHARMA

FRANCE

CEFALOTINE MERCK 1G POWDER FOR SOL. FORINJ.

1G/VIAL MERCK GENERIQUES FRANCE

CEFAN POWDER FOR INJECTION 1G/VIAL DEMO ABEE GREECE

CEFARIM 750MG POWDER FOR IM/IV 750MG M/S VITAPURECORPORATION

INDIA

CEFIX-200 TABLETS 200MG CIPLA LTD INDIA

CEFRADOX 500 CAPSULES 500MG AEGIS LTD. CYPRUS

CEFTRIAXONE 500MG POWDER FOR INJECTION 500MG MEDOCHEMIE LTD CYPRUS

CEFUROXIM 750MG CURASAN POWDER FOR INJECTION 750MG/VIAL CURASAN PHARMAGMBH

GERMANY

CEFUROXIME AXETILE TABLETS 250MG SHENZHENPHARMACEUTICALFACTORY

CHINA

CEFZIL (PROCEF) TABLETS 250MG BRISTOL MYERS SQUIBBS.P.A

ITALY

CEFZIL (PROCEF) POWDER FOR ORALSUSP.

250MG/5ML BRISTOL MYERS SQUIBBS.P.A

ITALY

CEFZIL (PROCEF) TABLETS 500MG BRISTOL MYERS SQUIBBS.P.A

ITALY

CEGROVIT EFFERVESCENT TABLET 1G DR.GROSSMANN AGPHARMACA

SWITZERLAND

CELANCE 0.05MG TABLETS TABLET 0.05MG ELI LILLY & COMPANYLIMITED

UNITED KINGDOM

CELANCE 0.25MG TABLETS TABLET 0.25MG ELI LILLY & COMPANYLIMITED

UNITED KINGDOM

CELANCE 1MG TABLETS TABLET 1MG ELI LILLY & COMPANYLIMITED

UNITED KINGDOM

CELEBIX -200 CAPSULE 200MG OKASA PHARMA PVTLTD — INDIA

INDIA

CELEBREX HARD CAPSULES 100MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

CELEBREX HARD CAPSULES 200MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

CELEBREX HARD CAPSULES 200MG PHARMACIA LIMITED UNITED KINGDOM

CELEBREX HARD CAPSULES 100MG PHARMACIA LIMITED UNITED KINGDOM

CELESTONE TABLETS 0.5MG SCHERING PLOUGHNV/SA

BELGIUM

CELEVAC TABLETS 500MG MONMOUTHPHARMACEUTICALS LTD.

UNITED KINGDOM

CELLCEPT CAPSULE 250MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 501

Trade Name Dosage Form Dose MA Holder Country

CELLCEPT 500MG TABLET 500MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

CELLIDRIN 100MG TABLET 100MG HENNIG ARZNEIMITTELGMBH & CO. KG

GERMANY

CELLIDRIN 300MG TABLET 300MG HENNIG ARZNEIMITTELGMBH & CO. KG

GERMANY

CELLUVISC EYE DROPS SOLUTION 1% ALLERGANPHARMACEUTICALS(IRELAND) LIMITED

IRELAND

CELLUVISC LUBRICANT EYE DROPS 1% W/V ALLERGAN UNITED STATES OFAMERICA

CEMAQUIN LOZENGES N/A CIMEX AG SWITZERLAND

CENOVIS 1000MG VIT CNATURAL ORANGE FLAV

TABLET 1000MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS 1000MG VITAMIN CNATURAL LEMON

TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS 50 + MULTI CAPSULEBOTTLE

CAPSULE N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS ANTIOXIDANT TABLETBOTTLE

TABLET N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS ANTIOXIDANT TABLETBOTTLE

TABLET N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS ARTHRITIC AID TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS B COMPLEX TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS B GROUP AND CVITAMINS

TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS B GROUP PLUS TABLETBOTTLE

TABLETS N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS CALCIUM 600MG ANDVITAMIN D

TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS CHILDREN'S CALCIUMPLUS

TABLET N/A FAULDING HEALTHCAREPTY

AUSTRALIA

CENOVIS CHILDREN'S COLD ANDFLU

TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS CHILDREN'SMULTIVITAMINS

TABLET N/A FAULDING HEALTHCAREPTY

AUSTRALIA

CENOVIS CHILDREN'S VIT C100MG ORANGE FL

TABLET(CHEWABLE) 100MG FAULDING HEALHCAREPTY LTD

AUSTRALIA

CENOVIS COD LIVER OIL CAPSULES 275MG FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS COLD AND FLU RELIEFLOZENGE

LOZENGE N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS CO-Q10UBIDECARENONE

CAPSULE 30MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS COUGH RELIEF LOZ. W/VIT. C AND ZN

LOZENGES N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

EL502 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CENOVIS CYSTITIS AID WITHCRANBERRY

TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS ECHINACEA COMPLEX TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS EVENING PRIMROSE OIL600MG

CAPSULE 600MG FAULDING HEALTHCAREPTY

AUSTRALIA

CENOVIS EVINING PRIMROSEOIL1000MG

CAPSULE 1000MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS EXECUTIVE B TABLETBOTTLE

TABLET N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS FOLIC ACID PLUSTABLET BOTTLE

TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS GINSENG PANAXGINSENG 500MG

TABLET 500MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS GUARANA 2000MG +GINSENG 500MG

FILM COATED TABLETS N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS HEALTHY HAIR, SKINAND NAILS

CAPSULE N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS IRON PLUS TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS LECITHIN 1.2G CAPSULE 1.2G FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS MAGNESIUM PLUS TABLET N/A FAULDING HEALTHCAREPTY

AUSTRALIA

CENOVIS MALE FORMULA TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS MAXEPA NATURAL FISHOIL CONC.

CAPSULE 1G FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS MEGA E 500MG CAPSULE 500MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS MEGA-MULTI EXTRASTRENGTH MV AND M

CAPSULE N/A FAULDING HEALTHCAREPTY

AUSTRALIA

CENOVIS MEN'S MULTI CAPSULEBOTTLE

CAPSULE N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS MULTIVITAMIN ANDMINERALS

TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS NATURAL E500IU CAPSULE 335MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS ODOURLESS GARLIC CAPSULE 10MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS OSTEO RELIEF TABLETBOTTLE

TABLETS N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS ST JOHN'SWORT(HYPERICUM)

TABLET 340MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS STUDENT STUDYFORMULA

TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS SUGARLESS C500MG(ORANGE)

TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 503

Trade Name Dosage Form Dose MA Holder Country

CENOVIS VALERIAN FORMULA TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS VITAMIN B6 TABLET 50MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS VITAMIN C 1000MGTABLET BOTTLE

TABLET 1000MG FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS VITAMIN C 250MG NAT.ORANGE FLV.

TABLET 250MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS WOMEN'S MULTICAPSULE BOTTLE

CAPSULES N/A FAULDING HEALTHCAREPTY LTD.

AUSTRALIA

CENOVIS YEAST 300MG TABLET 300MG FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CENOVIS ZINC PLUS 25MG TABLET 25MG FAULDING HEALTHCAREPTY

AUSTRALIA

CENVOVIS GINKGO PLUS TABLET N/A FAULDING HEALTHCAREPTY LTD

AUSTRALIA

CEPHADAR CAPSULES 250MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

CEPHADAR GRANULES FOR ORALSUSP.

125MG/5ML DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

CEPHADAR GRANULES FOR ORALSUSP.

125MG/5ML DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

CEPHALEXIN CAPSULES 250MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CEPHALEXIN CAPSULES 500MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CEPHALEXIN TABLETS 250MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CEPHALEXIN TABLETS 500MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CEPHALEXIN ORAL SUSPENSION 125MG/5ML NORTON HEALTHCARELIMITED

UNITED KINGDOM

CEPHALEXIN ORAL SUSPENSION 250MG/5ML NORTON HEALTHCARELIMITED

UNITED KINGDOM

CEPHALEXIN (TENKOREX)125MG/5ML

SUSPENSION 125MG/5ML KENTPHARMACEUTICALS LTD.

UNITED KINGDOM

CEPHALEXIN (TENKOREX)250MG/5ML

SUSPENSION 250MG/5ML KENTPHARMACEUTICALS

UNITED KINGDOM

CEPHALEXIN 250MG CAPSULE 250MG KENTPHARMACEUTICALS LTD.

UNITED KINGDOM

CEPHALEXIN 500MG CAPSULE 500MG KENTPHARMACEUTICALS LTD.

UNITED KINGDOM

CEPHALEXIN-RATIOPHARM 500 FILM COATED TABLET 500MG RATIOPHARM GMBH GERMANY

CEPHOS CAPSULE 500MG LABORATORIOFARMACEUTICOC.T.S.R.L.

ITALY

EL504 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CEPOREX HARD CAPSULES 500MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

CEPOREX HARD CAPSULES 500MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

CEPOREX CAPSULES 250MG CAPSULES 250MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

CEPOREX CAPSULES 500MG CAPSULES 500MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

CEPOREX SYRUP 125MG/5ML SYRUP 125MG/5ML GLAXO WELLCOME UKLTD

UNITED KINGDOM

CEPOREX SYRUP 250/5ML SYRUP 250MG/5ML GLAXO WELLCOME UKLTD

UNITED KINGDOM

CEREPAR TABLETS 75MG MEPHA PHARMA AG SWITZERLAND

CERETEC POWDER FOR INJECTION 0.5MG/VIAL NYCOMED AMERSHAMPLC

UNITED KINGDOM

CEROX TOPICAL SOLUTION N/A SPA ITALIANALABORATORI BOUTY

ITALY

CEROXIM TABLETS 250MG TABLETS 250MG RANBAXYLABORATORIES LTD.

INDIA

CERUMOL EAR DROPS EAR DROPS N/A LABORATORIES FORAPPLIED BIOLOGY LTD

UNITED KINGDOM

CETAVLEX ANTISEPTIC CREAM 0.5% W/W ZENECA LIMITED UNITED KINGDOM

CETAVLEX CREAM CREAM 1.25% V/ W BIOGLANLABORATORIES LTD

UNITED KINGDOM

CETILSAN SUGAR FREE LOZENGES N/A LABORATORIO CHIMICOFARMACEUTICO A.SELLA S.R.L.

ITALY

CETILSAN LOZENGES N/A LABORATORIO CHIMICOFARMACEUTICO A.SELLA S.R.L.

ITALY

CETOMACROGOL CREAM A BP CREAM 9% W/W ADAMS HEALTHCARELIMITED

UNITED KINGDOM

CETOR PWD. FOR SOL. FOR INF. 500U SANQUIN, CLB,PRODUCTS DIVISION

NETHERLANDS

CETRIMIDE ANTISEPTIC FIRST AIDCREAM

CREAM 0.5% W/W ANGLIAN PHARMA PLC UNITED KINGDOM

CETRIMIDE CREAM BP CREAM 0.5% W/W ADAMS HEALTHCARELIMITED

UNITED KINGDOM

CETROTIDE SOLUTION FORINJECTION.

0.25MG/ML ASTA MEDICA GERMANY

CETROTIDE SOLUTION FORINJECTION

3MG/3ML ASTA MEDICA GERMANY

CETROTIDE POWDER AND SOLVENTF/SOLUTION F/INJECTION

3MG/VIAL SERONO EUROPELIMITED

EUROPEAN COMMUNITY

CETROTIDE (X1VIAL) POWDER AND SOLVENTF/SOLUTION F/INJECTION

0.25MG/VIAL SERONO EUROPELIMITED

EUROPEAN COMMUNITY

CETROTIDE (X7VIALS) POWDER AND SOLVENTF/SOLUTION F/INJECTION

0.25MG/VIAL SERONO EUROPELIMITED

EUROPEAN COMMUNITY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 505

Trade Name Dosage Form Dose MA Holder Country

CEZIDIN POWDER FOR INJECTION 1G/VIAL DEMO ABEE GREECE

CHAPSTICK — CHERRY LIP BALM N/A WHITEHALLINTERNATIONAL INC

UNITED STATES OFAMERICA

CHAPSTICK — REGULAR LIP BALM N/A WHITEHALLINTERNATIONAL INC.

UNITED STATES OFAMERICA

CHAPSTICK — SUNBLOCK 15 LIP BALM N/A WHITEHALLINTERNATIONAL INC.

UNITED STATES OFAMERICA

CHARCOALTABLETS 125MG TABLET 125MG G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

CHEMITRIM CAPSULES N/A BIOMEDICA FOSCAMAINDUSTRIA CHIMICOFARMACEUTICA S.P.A.

ITALY

CHEMITRIM «FORTE» TABLET N/A BIOMEDICA FOSCAMAINDUSTRIA CHIMICOFARMACEUTICA S.P.A.

ITALY

CHIBROXIN 0.3% DPS EYE DROPS 0.3% W/V MERCK SHARP & DOHMEB.V.

NETHERLANDS

CHIBROXINE EYE DROPS 0.3%W/W MSD PAKISTAN

CHIBROXINE 0.3 COLLYRE EYE DROPS 3MG/ML MERCK SHARP & DOHMEB.V.

NETHERLANDS

CHILBLAIN CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

CHILDREN'S ADVIL SUSPENSION SUSPENSION NA WHITEHALL — ROBINS CANADA

CHILDREN'S DIMETAPP COLDAND ALLERGY

ELIXIR NA WITEHALLINTERNATIONAL

UNITED STATES OFAMERICA

CHIMAX TABLET 250MG CHIRON BV NETHERLANDS

CHLORAMPHENICAL EYE DROPS EYE DROPS 0.5% W/V SCHERING-PLOUGHLIMITED

UNITED KINGDOM

CHLORAMPHENICOL BP 250MG CAPSULE 250MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

CHLORAMPHENICOL EYEOINTMENT 1% BP

EYE OINTMENT 1% W/W PL 00156/0049 UNITED KINGDOM

CHLORASEPT 2000 ANTISEPTICSOL.

TOPICAL SOLUTION N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

CHLORHEXIDINE GLUCONATENATURAL FLAVOUR

OROMUCOSALSOLUTION

0.2% W/V ADAMS HEALTHCARELIMITED

UNITED KINGDOM

CHLOROQUINE PHOSPHATE TABLETS 100MG PHARMAMED LTD. MALTA

CHLOROQUINE PHOSPHATE TABLETS 250MG PHARMAMED LTD. MALTA

CHLOROQUINE PHOSPHATE SOLUTION FORINJECTION

40MG/ML PHARMAMEDPARENTERALS LTD.

MALTA

CHLOROQUINE PHOSPHATE SOLUTION FORINJECTION

80MG/2ML PHARMAMEDPARENTERALS LTD.

MALTA

CHLOROQUINE PHOSPHATE BP250MG

TABLET 250MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

CHLORPAMIDE BP 250MG TABLET 250MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

EL506 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CHLORPHENIRAMINE BP 4MG TABLET 4MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

CHLORPROMAZINE COATED TABLETS 25MG CLONMEL HEALTHCARELIMITED

IRELAND

CHLORPROMAZINE TABLETS 25MG REMEDICA LTD. CYPRUS

CHLORPROMAZINE BP 25MG TABLETS 25MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

CHLORPROPAMIDE TABLET 250MG MEDOCHEMIE LTD CYPRUS

CHLORPROPAMIDE TABLETS 250MG PHARMAMED LTD. MALTA

CHLORPROPAMIDE BP 100MG TABLET 100MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

CHLORURE DE THALLIUM[(201)TI] CIS BIO

SOLUTION FORINJECTION

37 MBQ/ML CIS BIO INTERNATIONAL FRANCE

CHOLECIS INTRAVENEOUSSOLUTION

NA CIS BIO INTERNATIONAL FRANCE

CHOLERA VACCINE BEHRING SUSPENSION FORINJECTION

N/A CHIRON BEHRING GMBH& CO

GERMANY

CHORAGEN 5000 POW. FOR INJ. ANDSOLVENT

5000 I.E. FERRING GMBH GERMANY

CHYMOL EMOLLIENT BALM OINTMENT NS ANGLIAN PHARMA PLC UNITED KINGDOM

CIBACEN FILM C. TABLETSDIVISIBLE

5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

CIBACEN TABLETS 10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

CICATRIN POWDER N/A WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

CICATRIN CREAM N/A WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

CICATRIN POWDER POWDER NA GLAXOWELLCOME PAKISTAN

CICLOFOSFAMIDA FILAXIS LYOPHILIZED POWDERFOR INJECTION

1G LABORATORIOS FILAXISSA

ARGENTINA

CICLOFOSFAMIDA FILAXIS LYOPHILIZED POWDERFOR INJECTION

200MG LABORATORIOS FILAXISSA

ARGENTINA

CIDOMYCIN EYE/EAR DROPS EYE/EAR DROPS 0.3% W/V ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

CIDOMYCIN INJECTION ADULT —80MG/2ML

SOLUTION FORINJECTION

80MG/2ML ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

CIDOMYCIN PAEDIATRICINJECTABLE 20MG/2ML

SOLUTION FORINJECTION

20MG/2ML ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

CIFEX ORAL SUSPENSION 100MG/5ML AEGIS LTD. CYPRUS

CIFEX 200 TABLETS 200MG AEGIS LTD. CYPRUS

CIFEX 400 TABLETS 400MG AEGIS LTD. CYPRUS

CIFLURON 250MG FILMCOATEDTABLETS

FILM COATED TABLETS NA IL KO ILAC VE KOZMETIKSAN. A.S. — TURKEY

TURKEY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 507

Trade Name Dosage Form Dose MA Holder Country

CIFRAN SOLUTION FORINJECTION

200MG RANBAXYLABORATORIES LTD.

INDIA

CILEST TABLET N/A JANSSEN-CILAG AG SWITZERLAND

CILOPRIN CUM ANAESTHETICO DROPS N/A JANSSEN-CILAG AG SWITZERLAND

CILOXAN OPHTHALMIC SOLUTION 3MG/ML S.A. ALCON-COUVREURN.V.

BELGIUM

CIMEDINE TABLETS 800MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

CIMET (CIMETIDINE TABLETS USP) TABLET 200MG IPCA LABORATORIESLIMITED

INDIA

CIMET-400 (CIMETIDINE TABLETSUSP)

TABLET 400MG IPCA LABORATORIESLIMITED

INDIA

CIMETIDINE TABLETS 200MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CIMETIDINE TABLETS 400MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CIMETIDINE TABLETS 800MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CINAZYN TABLETS 25MG ITALCHIMICI SPA ITALY

CINAZYN CAPSULE 75MG ITALCHIMICI SPA ITALY

CINNARIZINE TABLETS 15MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CIPLIN (COTRIMOXAZOLETABLETS IP)

TABLET N/A CIPLA LTD INDIA

CIPLIN SUSPENSION SUSPENSION N/A CIPLA LTD — INDIA INDIA

CIPLOX SOLUTION FORINJECTION

2MG/ML CIPLA LTD. INDIA

CIPLOX-250 TABLETS TABLETS 250MG CIPLA LTD. INDIA

CIPRAM TABLET 20MG H. LUNDBECK A/S DENMARK

CIPRAM TABLET 20MG LUNDBECK PAKISTAN

CIPRO HC OTIC SUSPENSION N/A ALCON LABORATORIESINC.

UNITED STATES OFAMERICA

CIPRO HC OTIC SUSPENSION EAR DROPS N/A ALCON CUSI S.A. SPAIN

CIPROBAY 100 INFUSION SOLUTION 100MG/50ML BAYER VITAL GMBH &CO. KG

GERMANY

CIPROBAY 200 INFUSION SOLUTION 200MG/100ML BAYER VITAL GMBH &CO. KG

GERMANY

CIPROBAY 250 FILM-COATED TABLET 250MG BAYER VITAL GMBH &CO. KG

GERMANY

CIPROBAY 500 FILM-COATED TABLET 500MG BAYER VITAL GMBH &CO. KG

GERMANY

CIPROBID-250 TABLETS 250MG CADILA HEALTHCARELIMITED

INDIA

EL508 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CIPRODAR FILM-COATED 250MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

CIPRODAR TABLETS 500MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

CIPROFLOXACIN INJECTION USP SOL FOR INJ 2MG/ML VYSALIPHARMACEUTICALSLIMITED

INDIA

CIPROFLOXACIN TABLETS USPCIFROTIL

FILM COATED TABLET 250MG TABLETS (INDIA) LIMITED INDIA

CIPROXIN TABLET 250MG BAYER PAKISTAN

CIPROXIN 100 INFUSION SOLUTION 100MG/50ML BAYER VITAL GMBH &CO. KG

GERMANY

CIPROXIN 200 INFUSION SOLUTION 200MG/100ML BAYER VITAL GMBH &CO. KG

GERMANY

CIPROXIN 250 FILM-COATED TABLET 250MG BAYER VITAL GMBH &CO. KG

GERMANY

CIPROXIN 250 FILM COATED TABLET 250MG BAYER PAKISTAN

CIPROXIN 400 INFUSION SOLUTION 400MG/200ML BAYER VITAL GMBH &CO. KG

GERMANY

CIPROXIN 500 FILM-COATED TABLET 500MG BAYER VITAL GMBH &CO. KG

GERMANY

CIPROXIN 750 FILM-COATED TABLET 750MG BAYER VITAL GMBH &CO. KG

GERMANY

CIROK SOLUTION FORINJECTION

2MG/ML KOREA UNITED PHARM.INC.

KOREA REPUBLIC

CIRRUS CAPSULE N/A U.C.B. S.A. BELGIUM

CISPLATIN 100MG/100ML SOLUTION FORINJECTION

1MG/ML PHARMACIA & UPJOHN(PERTH) PTY LTD.

AUSTRALIA

CISPLATIN 10MG/10ML SOLUTION FORINJECTION

1MG/ML PHARMACIA & UPJOHN(PERTH) PTY LTD.

AUSTRALIA

CISPLATIN 50MG/50ML SOLUTION FORINJECTION

1MG/ML PHARMACIA & UPJOHN(PERTH) PTY LTD.

AUSTRALIA

CISPLATIN INJECTION B.P SOLUTION FORINJECTION

N/A SERUM INSTITUTE OFINDIA LTD.

INDIA

CISPLATIN INJECTION SOLUTION SOLUTION FORINFUSION

1MG/ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

CISPLATINE MERCK 10MG/10ML SOL. TO DILUTE FORPERFUS

10MG/10ML MERCK GENERIQUES FRANCE

CISPLATINE MERCK 50MG/50ML SOL. TO DILUTE FORPERFUS

50MG/50ML MERCK GENERIQUES FRANCE

CISPLATINO SOLUTION FORINJECTION

50MG/50ML PHARMACIA ITALIA SPA ITALY

CISPLATINO SOLUTION FORINJECTION

10MG/10ML PHARMACIA ITALIA SPA ITALY

CITANEST OCTAPRESSIN SOLUTION FORINJECTION

N/A ASTRA LAKEMEDEL AB SWEDEN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 509

Trade Name Dosage Form Dose MA Holder Country

CITOMID RU SOLUTION FORINJECTION

1MG/2ML LEMERY S.A. MEXICO

CITOMID RU SOLUTION FORINJECTION

2MG/2ML LEMERY S.A. MEXICO

CITRAMAG POWDER EFFERVESCENT POWDER N/A BOIGLANLABORATORIES

UNITED KINGDOM

CITRATO ESPRESSO SPELLEGRINO

ORAL POWDER 7.12G / 40G SYNTHELABO S.P.A. ITALY

CITROVENOT TABLET 250MG BROS LTD GREECE

CITROVENOT TABLET 500MG BROS LTD GREECE

CLABAT DRY SYRUP N/A PT INTERBAT INDONESIA

CLABAT 500 FILM COATED CAPLET N/A PT INTERBAT INDONESIA

CLABAT 500 FILM-COATED TABLET N/A PT INTERBAT INDONESIA

CLABAT DRY SYRUP SYRUP N/A PT INTERBAT INDONESIA

CLABAT FORTE DRY SYRUP N/A PT INTERBAT INDONESIA

CLABAT FORTE DRY SYRUP 60 ML DRY SYRUP N/A PT INTERBAT INDONESIA

CLACIN CAPSULES 150MG KOREA UNITED PHARM.INC.

KOREA REPUBLIC

CLAFORAN 0.5G POWDER FOR IV-IMINJECT.

0.5G LABORATOIRES AVENTIS FRANCE

CLAFORAN 1G POWDER FOR IV-IMINJECT.

1G LABORATOIRES AVENTIS FRANCE

CLAFORAN 1G IM POWDER FOR INJECTION 1G LABORATOIRES AVENTIS FRANCE

CLAMIDE TABLET 5MG TABLET 5MG HOVID SDN BHD MALAYSIA

CLARICIDE TABLETS 250MG BILIM ILAC SANAYII VETICARET A.S.

TURKEY

CLARICIDE FILM COATED TABLETS 500MG BILIM ILAC SANAYII VETICARET A.S.

TURKEY

CLARIDAR FILM-COATED TABLETS 250MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

CLARINASE REPETABS N/A SCHERING-PLOUGH S.A. BELGIUM

CLARITHROMYCIN/GENEPHARM TABLETS 500MG GENEPHARM S.A. GREECE

CLARITHROMYCIN/GENEPHARM TABLETS 250MG GENEPHARM S.A. GREECE

CLARITINE TABLETS 10MG SCHERING-PLOUGHNV/SA

BELGIUM

CLARITINE SYRUP 1MG/ML SCHERING-PLOUGH S.A. BELGIUM

CLAVAMOX DT 400 POWDER F/ORAL SUSP. NA LABORATORIOS BIAL PORTUGAL

CLENASMA TABLET 0.02MG BIOMEDICA FOSCAMAINDUSTRIA CHIMICOFARMACEUTICA S.P.A.

ITALY

CLENASMA SYRUP 0.1MG/100ML BIOMEDICA FOSCAMAINDUSTRIA CHIMICOFARMACEUTICA S.P.A.

ITALY

EL510 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CLEXANE SOLUTION FORINJECTION

20MG/0.2ML LABORATOIRES AVENTIS FRANCE

CLEXANE SOLUTION FORINJECTION

40MG/0.4ML LABORATOIRES AVENTIS FRANCE

CLEXANE SOLUTION FORINJECTION

60MG/0.6ML BELLON, RHONE-POULENC RORER

FRANCE

CLEXANE SOLUTION FORINJECTION

80MG/0.8ML BELLON, RHONE-POULENC RORER

FRANCE

CLEXANE SOLUTION FORINJECTION

100MG/1ML BELLON, RHONE-POULENC RORER

FRANCE

CLEXANE 100MG/ML (FOR SCUSE)

INJECTABLE SOLN. IN PFS 100MG/ML BELLON, RHONE-POULENC RORER

FRANCE

CLEXANE 20MG/0.2ML INJECTABLE SOLN. IN PFS 20MG/0.2ML BELLON, RHONE-POULENC RORER

FRANCE

CLEXANE 40MG/0.4ML INJECTABLE SOLN. IN PFS 40MG/0.4ML BELLON, RHONE-POULENC RORER

FRANCE

CLEXANE 60MG/0.6ML (FOR SCUSE)

INJECTABLE SOLN. IN PFS 60MG/0.6ML BELLON, RHONE-POULENC RORER

FRANCE

CLEXANE 80MG/0.8ML (FOR SCUSE)

INJECTABLE SOLN. IN PFS 80MG/0.8ML BELLON, RHONE-POULENC RORER

FRANCE

CLINDAZYN INJECTABLE SOLUTION 300MG/2ML LEMERY, S.A. DE C.V. MEXICO

CLINOMEL N4-550 SOLUTION FORINFUSION

NA BAXTER HEALTHCARELIMITED

UNITED KINGDOM

CLINOMEL N5-800 SOLUTION FORINFUSION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

CLINOMEL N5-800 SOLUTION FORINFUSION

NA BAXTER HEALTHCARELIMITED

UNITED KINGDOM

CLINOMEL N6-900 SOLUTION FORINFUSION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

CLINOMEL N6-900 SOLUTION FORINFUSION

NA BAXTER HEALTHCARELIMITED

UNITED KINGDOM

CLINOMEL N7-1000 EMULSION FORINFUSION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

CLINOMEL N7-1000 SOLUTION FORINFUSION

NA BAXTER HEALTHCARELIMITED

UNITED KINGDOM

CLINT 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS

CLISMA LAX RECTAL SOLUTION N/A SOFAR SPA ITALY

CLOBAZAM 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS

CLOBEDERM-E CREAM 0.05G/100G ATCO LABORATORIES(PVT) LTD

PAKISTAN

CLOBETASOL PROPIONATETOPICAL SOLUTION

TOPICAL SOLUTION 0.5MG/G TAROPHARMACEUTICALS USA

UNITED STATES OFAMERICA

CLOCIP 1% W/W/ CREAM CREAM 1% CIPLA LTD. INDIA

CLOFENAC-25 ENTERIC COATEDTABLETS

25MG HOVID SDN.BHD. MALAYSIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 511

Trade Name Dosage Form Dose MA Holder Country

CLOFENAC-25 ENTERIC COATEDTABLET

25MG HOVID SDN. BHD(FORMERLY HO YANHOR SDN.BHD)

MALAYSIA

CLOMFRANIL 10MG TABLET 10MG NOVARTIS PAKISTAN

CLOMFRANIL 25MG TABLETS 25MG NOVARTIS PAKISTAN

CLOMID 50MG TABLET 50MG LABORATOIRES MARIONMERRELL DOW

FRANCE

CLOMID TABLETS 50 MG TABLETS 50 MG AVENTIS PHARMALIMITED

UNITED KINGDOM

CLOMIFENE TABLETS BP 50MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

CLOMIPHENE CITRATE(SEROPHENE) 50MG

TABLET 50MG TEVA PHARMACEUTICALINDUSTRIES LIMITED

ISRAEL

CLOMIPRAMINE CAPSULES 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CLOMIPRAMINE CAPSULES 25MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CLOMIPRAMINE CAPSULES 50MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CLOMIPRAMINE CAPSULE 10 MG APPROVEDPRESCRIPTION SERVICESLIMITED

UNITED KINGDOM

CLOMIPRAMINE BP CAPSULES 25MG APPROVEDPRESCRIPTION SERVICESLIMITED

UNITED KINGDOM

CLOMIPRAN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

CLOMIPRAN 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

CLONEA CREAM 10MG/G ALPHAPHARM PTYLIMITED

AUSTRALIA

CLONIL TABLETS 25MG INTASPHARMACEUTICALS LTD.

INDIA

CLONIL-10 TABLETS 10MG INTASPHARMACEUTICALS LTD.

INDIA

CLOPERAN 10MG TABLETS REMEDICA LTD. CYPRUS

CLOPIXOL TABLET 25MG H. LUNDBECK A/S DENMARK

CLOPIXOL TABLET 10MG H. LUNDBECK A/S DENMARK

CLOPIXOL TABLET 2MG H. LUNDBECK A/S DENMARK

CLOPIXOL DROPS 20MG/ML H. LUNDBECK A/S DENMARK

CLOPIXOL DEPOT INJECTION200MG/ML

SOLUTION FORINJECTION

200MG/ML H. LUNDBECK A/S DENMARK

CLOPIXOL-ACUPHASE INJECTION50MG/ML

SOLUTION FORINJECTION

50MG/ML H. LUNDBECK A/S DENMARK

CLOTAM (CLOTAN) CAPSULE 200MG GEA FARMACEUTISKFABRIK

DENMARK

CLOTRI-DENK 1% CREAM CREAM 10MG/G E. DENK OHG GERMANY

EL512 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CLOTRI-DENK 100 VAGINAL VAGINAL TABLET 100MG E. DENK OHG GERMANY

CLOTRIMADERM CREAM 1% W/W CREAM 1% W/W TAROPHARMACEUTICALS INC.

CANADA

CLOVE OIL BP DENTAL SOLUTION 100%V/V LCM LTD UNITED KINGDOM

CLOXACILLIN 250 CAPSULES 250MG REMEDICA LTD CYPRUS

CLOXACILLIN 250 CAPSULES 250MG AEGIS LTD. CYPRUS

CLOXACILLIN 500 CAPSULES 500MG AEGIS LTD. CYPRUS

CLOZAPINE TABLETS 25MG MYLANPHARMACEUTICALS INC

UNITED STATES OFAMERICA

CLOZAPINE TABLETS 100MG MYLANPHARMACEUTICALS INC

UNITED STATES OFAMERICA

CLOZOLE CREAM 1% W/W CREAM 1% W/W SM PHARMACEUTICALSSDN BHD

MALAYSIA

CO-AMILOFRUSE TABLETS NA CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

CO-AMILOZIDE TABLETS N/A CP PHARMACEUTICALSLTD.

UNITED KINGDOM

CO-AMILOZIDE TABLETS N/A CP PHARMACEUTICALSLTD.

UNITED KINGDOM

COAPROVEL 150/12.5MGTABLETS

TABLET N/A SANOFI PHARMABRISTOL-MYERS SQUIBBSNC

EUROPEAN COMMUNITY

COAPROVEL 300/12.5MG TABLET N/A SANOFI PHARMABRISTOL-MYERS SQUIBBSNC

EUROPEAN COMMUNITY

CO-CODAMOL TABLETS N/A CP PHARMACEUTICALSLTD.

UNITED KINGDOM

CO-CODAMOL TABLETS N/A HN NORTON & CO LTD UNITED KINGDOM

CO-CODAMOL TABLETS 8/500MG M & A PHARMACHEMLIMITED

UNITED KINGDOM

COCOIS OINTMENT N/A BIOGLANLABORATORIES LTD

UNITED KINGDOM

CO-DANTHRAMER SUSPENSION SUSPENSION N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

CODEINE LINCTUS BP ORAL SOLUTION 15MG/5ML WILLIAM RANSOM &SON PLC

UNITED KINGDOM

CODEINE LINCTUS BP ORAL SOLUTION N/A LCM LTD UNITED KINGDOM

CODEINE PHOSPHATE TABLETSBP

TABLETS 15MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

CODEINE PHOSPHATE TABLETSBP

TABLETS 30MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

CODEINE PHOSPHATE TABLETSBP

TABLETS 60MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

CODEINE PHOSPHATE TABLETSBP 30MG

TABLET 30MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 513

Trade Name Dosage Form Dose MA Holder Country

CO-DIOVAN FILM-COATED TABLETS N/A NOVARTISFARMACEYTICA S.A. -SPAIN

SPAIN

CO-DIOVAN 80/12.5MG FILM COATED TABLETS N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

CODIPRONT CAPSULES WITH SUSTACTION

N/A HEINRICH MACK NACHF GERMANY

CODIPRONT SYRUP N/A HEINRICH MACK NACHF GERMANY

CODIPRONT CUM EXPECTORANS CAPSULES N/A PFIZER AG SWITZERLAND

CODIPRONT CUM EXPECTORANS SYRUP N/A PFIZER AG SWITZERLAND

CODIPRONT CUM EXPECTORANS ORAL SUSPENSION NA PFIZER AG SWITZERLAND

CODIPRONT CUM EXPECTORANS CAPSULES NA PFIZER AG SWITZERLAND

CODIS TABLETS TABLET N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

CO-DYDRAMOL TABLETS N/A NORTON HEALTHCARELIMITED

UNITED KINGDOM

COFLOX-500 TABLETS 500MG MACLEODSPHARMACEUTICALS LTD

INDIA

COFSED LINCTUS ORAL SOLUTION N/A GALEN LIMITED UNITED KINGDOM

COFSED PAEDIATRIC LINCTUS ORAL SOLUTION N/A GALEN LIMITED UNITED KINGDOM

COLCHICINE TABLETS BP TABLETS 500MCG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

COLCHICINE TABLETS BP 500MICROGRAMS

TABLET 500MCG CP PHARMACEUTICALSLTD

UNITED KINGDOM

COLD CREAM SALICYLE CREAM N/A LABORATOIRES LAROCHE-POSAY

FRANCE

COLESTID GRANULES 5G PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

COLIRCUSI PILOCARPINA 2% EYEDROPS

EYE DROPS 2% ALCON CUSI SA SPAIN

COLLOMACK SOLUTION N/A HEINRICH MACK NACHF.GMBH & CO. KG

GERMANY

COLLU-HEXTRIL 0.2% SPRAY SOLUTION 0.2% W/V PARKE DAVIS FRANCE

COLOFAC SUGAR COATED TABLET 135MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

COLOFAC RETARD CAPSULE 200MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

COLOMYCIN TABLETS 1.5MU PHARMAX LIMITED UNITED KINGDOM

COLOMYCIN SYRUP 250,000 U/5ML PHARMAX LIMITED UNITED KINGDOM

COLOMYCIN INJECTION POWDER FORRECONSTITUTION

0.5MU PHARMAX LIMITED UNITED KINGDOM

COLOMYCIN INJECTION POWDER FORRECONSTITUTION

1MU PHARMAX LIMITED UNITED KINGDOM

COLOMYCIN STERILE POWDER STERILE POWDER 1G PHARMAX LIMITED UNITED KINGDOM

EL514 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

COLOSPASMIN FORTE TABLETS 135MG EGYPTIANINTERNATIONALPHARMACEUTICALINDUSTRIES CO (EIPICO)

EGYPT

COLPOCINT-T SOLUTION FORINJECTION

500MG/1000ML DEMO ABEE GREECE

COLPOSEPTINE GYNAECOLOGICALTABLETS

N/A LABORATOIRETHERAMEX

FRANCE

COLPOTROPHINE VAGINAL CAPSULE 0.01G LABORATOIRETHERAMEX

MONACO

COLPOTROPHINE 1% CREAM 1G/100G LABORATOIRETHERAMEX

MONACO

COLSOR CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

COLSOR LOTION TOPICAL SOLUTION N/A J PICKLES & SONS UNITED KINGDOM

COLTRAMYL 4MG TABLET 4MG LABORATOIRESROUSSEL

FRANCE

COLTRAMYL 4MG/2ML SOLUTION FOR IMINJECTION

4MG/2ML LABORATOIRESROUSSEL

FRANCE

COLYTE POWDER FOR ORALSOLUTION

N/A SCHWARZ PHARMA INC. UNITED STATES OFAMERICA

COMAZOL CREAM 1% W/W CREAM 1% W/W CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

COMBACID N GEL N/A G.STREULI & CO. AG SWITZERLAND

COMBINATION Q-BIOCHEMIC TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

COMBIVENT UDVS INHALATION SOLUTION N/A BOEHRINGER INGELHEIMLTD

UNITED KINGDOM

COMPOUND BENZOIN TINCTUREBP

CONC. FOR INHALATIONSOLN

N/A WILLIAM RANSOM &SON PLC

UNITED KINGDOM

COMPOUND SOD.LACTATE WITH5%W/V GLUCOSE

INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

COMPOUND SODIUM LACTATE IVINFUSION

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

COMPOUND SODIUM LACTATEIVI BP -HARTMANN

INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

COMPOUND THYMOL GLYCERINBP

OROMUCOSALSOLUTION

N/A WILLIAM RANSOM &SON PLC

UNITED KINGDOM

COMTAN FILM COATED TABLETS 200MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

COMTAN FILM COATED TABLETS 200MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

COMTAN FILM-COATED TABLETS 200MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

CONCAVIT SOFT GELATINECAPSULES

N/A WALLACEMANUFACTURINGCHEMISTS LIMITED

UNITED KINGDOM

CONCAVIT DROPS N/A WALLACEMANUFACTURINGCHEMISTS LIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 515

Trade Name Dosage Form Dose MA Holder Country

CONDYLINE SOLUTION 5MG/ML YAMANOUCHI PHARMAB.V.

NETHERLANDS

CONOTRANE CREAM N/A YAMANOUCHI PHARMALIMITED

UNITED KINGDOM

CONTAC 12 CAPSULE 50MG MENLEY & JAMESLIMITED

UNITED KINGDOM

CONTAC 400 CAPSULES GASTRO-RESISTANTGRANULES

N/A MENLEY & JAMES LTDT/A SMITHKLINEBEECHAM CONSUMERHEALTHCAR

UNITED KINGDOM

CONTACT ADMINISTRATOR XXX XXX GERMANY

CONTRACIDE ORAL SUSPENSION N/A LABORATOIRESNORGINE PHARMA

FRANCE

CONTRACIDE ORAL SUSPENSION N/A LABORATOIRESNORGINE PHARMA

FRANCE

CONTRATUBEX GEL N/A MERZ+CO. GMBH & CO. GERMANY

COOL MINT LISTERINE SOLUTION N/A WARNER-LAMBERT S.A.(PTY) LTD

SOUTH AFRICA

CO-PROXAMOL TABLETS COATED TABLET N/A SANOFI WINTHROP LTD UNITED KINGDOM

CO-PROXAMOL TABLETS BP TABLET N/A M & A PHARMACHEMLIMITED

UNITED KINGDOM

CORACTEN RETARD CAPSULE 20MG SMITHKLINE BEECHAMPHARMA GMBH

GERMANY

CORADAY MR 20MG TABLET TABLET 20MG GENERICS (UK) LIMITED UNITED KINGDOM

CORDARONE 150MG/3ML IV INJECTABLESOLUTION

150MG/3ML SANOFI WINTHROP FRANCE

CORDARONE 200MG SCORED TABLET 200MG SANOFI WINTHROP FRANCE

CORDARONE X/AMIODARONEHCL 100MG TABLETS

TABLET 100MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

CORDICANT CAPSULES 5MG MUNDIPHARMA GMBH GERMANY

CORDICANT CAPSULE 10MG MUNDIPHARMA GMBH GERMANY

CORDICANT RETARD TABLETS 20MG MUNDIPHARMA GMBH GERMANY

CORDICANT RETARD PROLONGED RELEASETABLETS

20MG MUNDIPHARMA GMBH GERMANY

CORDILOX SR TABLETS 240MG NORTON HEALTHCARELTD

UNITED KINGDOM

CORDIMEDIL FILM COATED TABLETS 300MG KLEVA LIMITED GREECE

CORGARD TABLETS 40MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CORGARD TABLETS 80MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CORGARETIC 40MG/5MG TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

CORGARETIC 80MG/5MG TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

CORICIDIN-D EXTRA STRENGTH TABLETS N/A S-P CANADA CANADA

CORITUSSAL CAPSULES N/A HEINRICH MACK NACHF GERMANY

EL516 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CORITUSSAL SYRUP SUSPENSION N/A HEINRICH MACK NACHF GERMANY

CORN REMOVAL PLASTERS PLASTER 40%W/W SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

CORN REMOVAPADS PLASTER 40%W/W SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

CORPRILOR TABLETS 20MG LABORATORIOS RUBIOS.A

SPAIN

CORSODYL DENTAL GEL 1% W/W DENTAL GEL 1% W/W BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

CORSODYL MINT MOUTHWASH0.2% W/V

DENTAL SOLUTION 0.2% W/V BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

CORSODYL MOUTHWASH 0.2%W/V

DENTAL SOLUTION 0.2% W/V BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

CORTEF TABLETS 10MG PHARMACIA & UPJOHNCOMPANY

UNITED STATES OFAMERICA

CORTEF HYDROCORTISONETABLETS

TABLETS 20MG PHARMACIA ANDUPJOHN COMPANY

UNITED STATES OFAMERICA

CORTIFOAM RECTAL FOAM N/A SCHWARZ PHARMA INC. UNITED STATES OFAMERICA

CORTISONE ACETATE TABLET 25MG REKAHPHARMACEUTICALINDUSTRY LTD

ISRAEL

CORTODERM ONT 1% W/W OINTMENT 1% W/W TAROPHARMACEUTICALS INC.

CANADA

CORTOPIN HYDROCORTISONECREAM

CREAM 1% W/W PINEWOODLABORATORIES LIMITED

UNITED KINGDOM

CORTOPIN HYDROCORTISONECREAM

CREAM 1% W/W PINEWOODLABORATORIES LTD T/APINEWOODHEALTHCARE

UNITED KINGDOM

CORTOPIN HYDROCORTISONEOINTMENT

OINTMENT 1% W/W PINEWOODLABORATORIES LTD T/APINEWOODHEALTHCARE

UNITED KINGDOM

CORVASAL 2MG TABLET 2MG LABORATOIRESHOECHST

FRANCE

CORVASAL 4MG TABLET 4MG LABORATOIRESHOECHST

FRANCE

COSOPT EYEDROPS N/A MERCK SHARP ANDDOHME LIMITED

UNITED KINGDOM

COSTI 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

CO-TENIDONE TABLETS 100MG/25MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CO-TENIDONE TABLETS 50MG/12.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 517

Trade Name Dosage Form Dose MA Holder Country

COTRIM SUSPENSION N/A MEDOCHEMIE LTD CYPRUS

COTRIM 480MG TABLET N/A MEDOCHEMIE LTD CYPRUS

COTRIM D.S. TABLET N/A MEDOCHEMIE LTD CYPRUS

COTRIMHEXAL FORTE TABLET N/A HEXAL AG GERMANY

CO-TRIMOXAZOLE TABLETS 960MG PHARMAMED LTD. MALTA

CO-TRIMOXAZOLE TABLETS 960MG PHARMAMED LTD. MALTA

CO-TRIMOXAZOLE TABLETS N/A MACLEODS INDIA

CO-TRIMOXAZOLE BP 400/80MG TABLET N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

COTRIMOXAZOLE TABLETSB.P.480MG

UNCOATED TABLET N/A MEDICORPTECHNOLOGIES INDIALTD.,

INDIA

COUMADIN TABLETS 1MG DUPONT PHARMA UNITED STATES OFAMERICA

COUMADIN TABLETS 2.5MG DUPONT PHARMA UNITED STATES OFAMERICA

COUMADIN TABLETS 5MG DUPONT PHARMA UNITED STATES OFAMERICA

COUMADIN TABLETS 2MG DUPONTPHARMACEUTICALSCOMPANY (DUPONTPHARMA)

UNITED STATES OFAMERICA

COUMADIN TABLETS 3MG DUPONTPHARMACEUTICALSCOMPANY

UNITED STATES OFAMERICA

COUMADIN TABLETS 6MG DUPONTPHARMACEUTICALSCOMPANY

UNITED STATES OFAMERICA

COUMADIN TABLETS 4MG DUPONTPHARMACEUTICALSCOMPANY

UNITED STATES OFAMERICA

COUMADIN TABLETS 7.5MG DUPONTPHARMACEUTICALSCOMPANY

UNITED STATES OFAMERICA

COUMADIN TABLETS 10MG DUPONTPHARMACEUTICALSCOMPANY

UNITED STATES OFAMERICA

COVERSYL TABLET 4MG SERVIER PAKISTAN

COVERSYL TABLETS 4MG LES LABORATOIRESSERVIER

FRANCE

COVERSYL 2MG TABLET 2MG LES LABORATOIRESSERVIER

FRANCE

COVONIA BRONCHIAL BALSAM ORAL SOLUTION N/A THORNTON & ROSS LTD UNITED KINGDOM

COVONIA MENTHOLATEDCOUGH MIXTURE

ORAL SOLUTION N/A LCM LTD UNITED KINGDOM

COVONIA NIGHT TIME FORMULA ORAL SOLUTION N/A THORNTON & ROSS UNITED KINGDOM

EL518 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

COXERIN CAPSULES 250MG MACLEODSPHARMACEUTICALS LTD

INDIA

COZAAR TABLET 100MG MERCK SHARP ANDDOHME LIMITED

UNITED KINGDOM

COZAAR 50MG TABLET 50MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

COZAAR TABLETS TABLETS 50MG MSD PAKISTAN

CRAMPEX TABLETS TABLET N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

CREON 10 000 CAPSULE 150MG SOLVAY ARZNEIMITTELGMBH

GERMANY

CREON 25 000 CAPSULE 300MG SOLVAY ARZNEIMITTELGMBH

GERMANY

CRIXIVAN HARD CAPSULE 400MG MERCK SHARP & DOHME UNITED KINGDOM

CROMABAK EYEDROPS 2% N/A LABORATOIRES THEA FRANCE

CROMAL EYE DROPS 2%W/V CIPLA LTD INDIA

CROMAL-5 INHALER N/A CIPLA LIMITED INDIA

CROMOGEN INHALER 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CROMOGEN EASI BREATHEINHALER

INHALER 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

CROMOGEN STERI-NEB SOLUTION FORNEBULISATION

20MG/2ML STERIPAK LIMITED UNITED KINGDOM

CRYSTACIDE CREAM 1% CREAM 1% W/ W BIOGLANLABORATORIES LTD

UNITED KINGDOM

CUATRODERM CREAM N/A SCHERING PLOUGH S.A. SPAIN

CUPAL HONEY AND LEMONMELTUS COUGH LINCTUS

ORAL SOLUTION 50MG/5ML CUPAL LTD UNITED KINGDOM

CUPROFEN COATED TABLETS 400 MG CUPAL LIMITED UNITED KINGDOM

CUPROFEN IBUPROFEN COATED TABLETS 200 MG CUPAL LIMITED UNITED KINGDOM

CURAM TABLET N/A BIOCHEMIE GMBH AUSTRIA

CURZON TABLETS TABLET N/A CATHAY OFBOURNEMOUTH LTD T/AGERARD HOUSE

UNITED KINGDOM

CUSIMOLOL 0.25% EYE DROPS 0.25% W/V ALCON CUSI, S.A. SPAIN

CUSIMOLOL 0.5% EYE DROPS 0.5% W/V ALCON CUSI, S.A. SPAIN

CUSIMOLOL 0.5% EYE DROPS 0.5% W/V LABORATORIOS CUSIS.A.

SPAIN

CUTIVATE CREAM CREAM 0.05%W/W GLAXO WELLCOME UKLIMITED T/A GLAXOLABORATORIES

UNITED KINGDOM

CUTIVATE CREAM 0.05% CREAM 0.05% W/W GLAXO WELLCOME UKLTD

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 519

Trade Name Dosage Form Dose MA Holder Country

CUTIVATE OINTMENT OINTMENT 0.05%W/W GLAXO WELLCOME UKLIMITED T/A GLAXOLABORATORIES

UNITED KINGDOM

CUTIVATE OINTMENT 0.005% OINTMENT 0.005% GLAXO WELLCOME UKLTD

UNITED KINGDOM

CYCLIMORPH 10 SOLUTION FORINJECTION

N/A WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

CYCLIMORPH 15 SOLUTION FORINJECTION

N/A WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

CYCLOGYL 0.5% OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVREURN.V.

BELGIUM

CYCLOSPORINE (IMUSPORIN-100) CAPSULES 100MG CIPLA LIMITED INDIA

CYCLOSPORINE (IMUSPORIN-25) SOFT GELATIN CAPSULES 25MG CIPLA LIMITED INDIA

CYCLOSPORINE (IMUSPORIN-50) SOFT GELATIN CAPSULE 50MG CIPLA LIMITED INDIA

CYKLOKAPRON SOLUTION FORINJECTION

100MG/ML PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

CYKLOKAPRON TABLETS 500MG PHARMACIA & UPJOHNSVERIGE SA

ITALY

CYKLOKAPRON SOLUTION FORINJECTION

100MG/ML PHARMACIA & UPJOHNN.V./S.A.

BELGIUM

CYKLOKAPRON SOLUTION F/PARENTERAL USE

100MG/ML PHARMACIA NV/SA BELGIUM

CYKLOKAPRON SOL. FOR PARENTERALUSE

100MG/ML PHARMACIA NV/SA BELGIUM

CYKLOKAPRON SOL. FOR PARENTERALUSE

100MG/ML PHARMACIA NV/SA BELGIUM

CYMALON GRANULES FOR ORALSOLN.

N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

CYMALON GRANULES FOR ORALSUSPE.

N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

CYMEX CREAM CREAM N/A PL 00083/0026 UNITED KINGDOM

CYNT 0.2 FILM-COATED TABLET 0.2MG BEIERSDORF-LILLY GMBH GERMANY

CYNT 0.3 FILM-COATED TABLET 0.3MG BEIERSDORF-LILLY GMBH GERMANY

CYNT 0.4 FILM-COATED TABLET 0.4MG BEIERSDORF-LILLY GMBH GERMANY

CYPROCUR TABLETS 50 MG CIPLA LTD — INDIA INDIA

CYPROTERONE ACETATE TABLETS 50 MG GENERICS (UK) LIMITED— UK

UNITED KINGDOM

CYPROTERONE ACETATE TABLETS 50MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

CYSTOCALM GRANULES FOR ORALSOL.

4G GALPHARMHEALTHCARE LIMITED

UNITED KINGDOM

CYSTOFEM CYSTITIS RELIEFGRANULES

GRANULES N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

CYSTRIN 5MG TABLET 5MG LEIRAS OY FINLAND

EL520 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CYTARABINE INJECTION VIAL SOLUTION FORINJECTION

100MG/5ML F.H. FAULDING & CO.LTD (T/A DAVID BULLLABS)

UNITED KINGDOM

CYTOBLASTIN AQUEOUS SOLUTION FORINJECTION

10MG/ML CIPLA LIMITED INDIA

CYTOCRISTIN AQUEOUS SOLUTION FORINJECTION

1MG/1ML CIPLA LIMITED INDIA

CYTODROX CAPSULES 500MG CIPLA LTD INDIA

CYTOPLATIN-10 AQUEOUS SOLUTION FORINJECTION

10MG/20ML CIPLA LIMITED INDIA

CYTOPLATIN-50 AQUEOUS SOLUTION FORINJECTION

50MG/50ML CIPLA LIMITED INDIA

CYTOSAR POWDER FOR INJECTION 100MG/VIAL PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

CYTOSAR POWDER FOR INJECTION 500MG PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

CYTOTAM-20 TABLETS 20MG CIPLA LTD INDIA

CYTOTEC TABLETS 200MCG MONSANTO PLC UNITED KINGDOM

CYTOTEC TABLETS 200MCG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

CYTOTEC TABLETS 200MCG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

CYTOTEC 200 MCG TABLETS TABLETS 200 MCG PHARMACIA LIMITED UNITED KINGDOM

CYTOTREX TABLETS 2.5MG CIPLA LTD. INDIA

CZARTAN TABLET 25MG MACLEODSPHARMACEUTICALS LTD

INDIA

D.D.D. MEDICATED LOTION TOPICAL SOLUTION N/A D D D LIMITED UNITED KINGDOM

D.T. COQ INJECTABLE SUSPENSION N/A (IN PFS) PASTEUR MERIEUX FRANCE

D.T. POLIO VACCINE VACCINE N/A PASTEUR MERIEUX FRANCE

D.T. VAX INJECTABLEPREPARATION

N/A PASTEUR MERIEUX FRANCE

DACARBAZINE FOR INJECTION POWDER FOR INJECTION 20MG/ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

DADCROME EYE DROPS 220MG/10ML DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

DAFLON TABLET 150MG SERVIER PAKISTAN

DAFLON 500MG TABLET LES LABORATOIRESSERVIER

FRANCE

DAFLON 375MG COATED TABLET 375MG LES LABORATOIRESSERVIER

FRANCE

DAFLON 500MG COATED TABLET 500MG LABORATOIRES SERVIER FRANCE

DAIVONEX CREAM 50MCG/G LEO PHARMACEUTICALPRODUCTS LIMITED

DENMARK

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 521

Trade Name Dosage Form Dose MA Holder Country

DAIVONEX SCALP SOLUTION 50MCG/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

DAIVONEX OINTMENT 50MCG/G LEO PHARMACEUTICALPRODUCTS

DENMARK

DAKTACORT CREAM N/A JANSSEN-CILAG N.V. BELGIUM

DAKTACORT CREAM N/A JANSSEN PAKISTAN

DAKTARIN CREAM 20MG/G JANSSEN-CILAG N.V. BELGIUM

DAKTARIN LOTION 20MG/G JANSSEN-CILAG N.V. BELGIUM

DAKTARIN LOTION 20MG/G JANSSEN FARMACEUTICAPORTUGAL

PORTUGAL

DAKTARIN CUTANEOUS SOLUTION 20MG/ML JANSSEN FARMACEUTICAPORTUGAL

PORTUGAL

DAKTARIN 2% ORAL GEL 2% W/W JANSSEN-CILAG N.V. BELGIUM

DAKTARIN 2% TINCTURE 2% W/V JANSSEN-CILAG N.V. BELGIUM

DAKTARIN 2% POWDER 20MG/G JANSSEN-CILAG N.V. BELGIUM

DALACIN TOPICAL SOLUTION 10MG/ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

DALACIN VAGINAL CREAM 2%W/W PHARMACIA LIMITED UNITED KINGDOM

DALACIN C CAPSULE 150MG UPJOHN PAKISTAN

DALACIN C SOLUTION FORINJECTION

300MG/2ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

DALACIN C SOLUTION FORINJECTION

600MG/4ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

DALACIN C ORAL CAPSULES 150MG PHARMACIA NV/AS BELGIUM

DALACIN C 150MG ORAL CAPSULES 150MG PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

DALACIN C 75MG ORAL CAPSULES 75MG PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

DALACIN C 75MG/5ML SYRUP 75MG/5ML PHARMACIA & UPJOHNN.V./ S.A

BELGIUM

DALACIN T LOTION N/A UPJOHN PAKISTAN

DALACIN T TOPICAL SOLUTION 10MG/1ML PHARMACIA NV/AS BELGIUM

DALACIN VAGINAL OVULES VAGINAL OVULES 100MG PHARMACIA & UPJOHNCOMPANY

UNITED STATES OFAMERICA

DALIVIT DROPS ORAL EMULSION N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

DALMANE CAPSULES CAPSULES 15MG ICN PHARMACEUTICALSLIMITED

UNITED KINGDOM

DALMANE CAPSULES CAPSULES 30MG ICN PHARMACEUTICALSLIMITED

UNITED KINGDOM

DANATROL 200MG CAPSULE 200MG SANOFI WINTHROP FRANCE

DANOGEN-200 CAPSULES 200MG CIPLA LTD. INDIA

EL522 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DANOL 200MG CAPSULES CAPSULE 200MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

DAONIL TABLET 5MG HOECHST PAKISTAN

DAONIL TABLET 5MG HOECHST MARIONROUSSEL

PAKISTAN

DAONIL 5MG TABLET 5MG LABORATOIRESHOECHST

FRANCE

DAONIL FAIBLE 1.25MG TABLET 1.25MG LABORATOIRESHOECHST

FRANCE

DAPA-TABS TABLETS 2.5MG ALPHAPHARM PTYLIMITED

AUSTRALIA

DAPRIL 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

DAPRIL 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS

DAPRIL 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

DARAPRIM TABLETS 25MG WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

DARAZIO TABLETS NA DELTA HF ICELAND

DAREN TABLETS 2.5MG DELTA HF ICELAND

DAREN TABLETS 5MG DELTA HF ICELAND

DAREN TABLETS 10MG DELTA HF ICELAND

DAREN TABLETS 20MG DELTA HF ICELAND

DAUNOBLASTINA POWDER FOR INJECTION 20MG/VIAL PHARMACIA & UPJOHNS.P.A.

ITALY

DAUNOBLASTINA POWDER FOR SOLN FORINJECTION

20MG/10ML PHARMACIA ITALIA S.P.A ITALY

DAY NURSE ORAL SOLUTION NA BEECHAM GROUP PLCT/A GLAXOSMITHKLINECONSUMERHEALTHCARE

UNITED KINGDOM

DAY NURSE HARD CAPSULES NA BEECHAM GROUP PLCT/A GLAXOSMITHKLINECONSUMERHEALTHCARE

UNITED KINGDOM

DAY NURSE CAPSULES CAPSULE N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

DAY NURSE CAPSULES CAPSULE N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

DAYTIME COLD AND FLU LIQUIDCAPSULES

CAPSULE N/A STANLEYPHARMACEUTICALS LTD

CANADA

DAZIL 30 TABLETS 30MG AEGIS LTD. CYPRUS

DAZIL 60 TABLETS 60MG AEGIS LTD. CYPRUS

DAZIL 90 TABLETS 90MG AEGIS LTD CYPRUS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 523

Trade Name Dosage Form Dose MA Holder Country

DBL CARBOPLATIN INJECTIONVIAL

SOLUTION FORINJECTION

150MG/15ML F.H. FAULDING & CO LTD(T/A DAVID BULL LABS)

AUSTRALIA

DBL CISPLATIN INJECTION VIAL SOLUTION FORINJECTION

50MG/50ML F.H. FAULDING & CO LTD(T/A DAVID BULL LABS)

AUSTRALIA

DBL DAUNORUBICIN 20MG/4ML SOLUTION FORINJECTION

20MG/4ML F.H. FAULDING & CO LTD AUSTRALIA

DBL HYOSCINE HYDROBROMIDE SOLUTION FORINJECTION

400MCG F.H FAULDING & CO.LIMITED T/A DAVIDBULL LABORATORIES

AUSTRALIA

DBL METHOTREXATE INJECTIONVIAL

SOLUTION FORINJECTION

50MG/2ML F.H. FAULDING & CO LTD(T/A DAVID BULL LABS)

AUSTRALIA

DBL MORPHINE SULPHATE SOLUTION FORINJECTION

10MG/ML F.H. FAULDING & CO LTD AUSTRALIA

DBL MORPHINE SULPHATE SOLUTION FORINJECTION

15MG/1ML F.H. FAULDING & CO LTD AUSTRALIA

DBL PETHIDINE HYDROCHLORIDE SOLUTION FORINJECTION

50MG/ML F.H. FAULDING & CO LTD AUSTRALIA

DDAVP INTRANASAL SOL. NASAL DROPS 0.01% FERRINGPHARMACEUTICALSLIMITED

UNITED KINGDOM

DDAVP TABLETS TABLET 0.1MG FERRINGPHARMACEUTICALS LTD

UNITED KINGDOM

DDD MEDICATED LOTION TOPICAL SOLUTION NA DDD LIMITED UNITED KINGDOM

DE WITTS ANTACID TABLETS TABLET N/A E C DE WITT & CO LTD UNITED KINGDOM

DE WITTS THROAT LOZENGES LOZENGE N/A E C DE WITT & CO LTD UNITED KINGDOM

DEANXIT SUGAR-COATED TABLET N/A LUNDBECKARZNEIMITTELGESELLSCHAFT M.B.H.

AUSTRIA

DECADRON 4MG/ML INJECTION FLUID 4MG/ML MERCK SHARP & DOHMEB.V.

NETHERLANDS

DECADRON EAR + NEOMYCIN0.1% DPS

EAR DROPS N/A MERCK SHARP & DOHMEB.V.

NETHERLANDS

DECADRON EYE + NEOMYCIN0.1% DPS

EYE DROPS N/A MERCK SHARP & DOHMEB.V.

NETHERLANDS

DECA-DURABOLIN SOLUTION FORINJECTION

25MG/ML ORGANONLABORATORIES

UNITED KINGDOM

DECA-DURABOLIN 25MG/ML SOLUTION FORINJECTION

25MG/ML ORGANONLABORATORIES LIMITED

UNITED KINGDOM

DECA-DURABOLIN 50MG/MLINJECTION

SOLUTION FORINJECTION

50MG/ML ORGANONLABORATORIES LIMITED

UNITED KINGDOM

DECAPEPTYL 0.1MG POWDER FOR INJEC.SUSPEN.

0.1MG LABORATOIRES IPSENBIOTECH

FRANCE

DECAVIT CAPSULE N/A ROWAPHARMACEUTICALS LTD

IRELAND

DECLOVIR CREAM 5% W/W HOE PHARMACEUTICALSSDN.BHD.

MALAYSIA

DECLOVIR CREAM CREAM 5% W/W HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

EL524 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DECOCORT CREAM N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

DECOCORT CREAM N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

DECOCORT CREAM CREAM N/A HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

DECONGESTANT NASAL SPRAY0.1% W/V

AEROSOL 0.1% W/V STANLEYPHARMACEUTICALS LTD

CANADA

DECOZOL CREAM N/A HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

DECOZOL CREAM 2% W/W HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

DECUTAN SOFT GELATIN CAPSULES 10MG DELTA LIMITED ICELAND

DECUTAN SOFT GELATIN CAPSULES 20MG DELTA LIMITED ICELAND

DEEP FREEZE AEROSOL SPRAY TOPICAL SPRAY N/A THE MENTHOLATUMCOMPANY LIMITED

UNITED KINGDOM

DEEP HEAT MAXIMUM STRENGTHCREAM

CREAM N/A THE MENTHOLATUMCOMPANY LIMITED

UNITED KINGDOM

DEEP RELIEF GEL N/A THE MENTHOLATUMCOMPANY LIMITED

UNITED KINGDOM

DEFAROL TABLET 10MG PROEL S.A. CORONIS E.G. GREECE

DEFFERINE GEL 0.1% W/W LABORATOIREGALDERMA

FRANCE

DEHYDRATED ALCOHOL BP FORINJECTION

SOLUTION FORINJECTION

100%V/V MACARTHYSLABORATORIES LTD

UNITED KINGDOM

DEHYDROBENZPERIDOL AMPOULE 2.5MG/ML JANSSEN-CILAG N.V. BELGIUM

DELIMON GEL FOR EXTERNAL USE 11.6MG/1G PHARMATHEN LTD. GREECE

DELTACOTRIL ENTERIC COATEDTABLET

2.5MG PFIZER LIMITED UNITED KINGDOM

DEMOCINETIC CREAM N/A GEYMONAT SPA ITALY

DENAVIR 1% (VECTAVIR) CREAM 1% W/W LABORATOIRESSMITHKLINE BEECHAM

FRANCE

DENEREL 0.2MG/ML SYRUP 0.2MG/ML MEDOCHEMIE LTD CYPRUS

DENEREL 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

DENEX TABLET 100MG MEDOCHEMIE LTD CYPRUS

DE-NOL TABLETS 120MG YAMANOUCHI PHARMAB.V.

NETHERLANDS

DENTINOX CRADLE CAPTREATMENT SHAMPOO

SHAMPOO N/A D D D LIMITED UNITED KINGDOM

DENTINOX INFANT COLIC DROPS ORAL SUSPENSION N/A D D D LIMITED UNITED KINGDOM

DENTINOX TEETHING GEL DENTAL GEL N/A D D D LIMITED UNITED KINGDOM

DEPACON SOLUTION FORINJECTION

500MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 525

Trade Name Dosage Form Dose MA Holder Country

DEPAKINE 400MG/4ML FREEZE-DRIED POWDER 400MG/4ML SANOFI-SYNTHELABOFRANCE

FRANCE

DEPAKOTE DELAYED RELEASETABLETS

500MG ABBOTT LABORATORIES UNITED STATES OFAMERICA

DEPO-MEDROL STERILE AQ. SUSP. FORINJ

40MG/ML PHARMACIA & UPJOHNN.V./ S.A

BELGIUM

DEPO-MEDROL STERILE AQ. SUSP. FORINJ

80MG/2ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

DEPO-PROVERA STERILE AQ. SUSP. FORINJ

500MG/VIAL PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

DEPO-PROVERA STERILE AQ. SUSP. FORINJ

1000MG/VIAL PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

DEPO-PROVERA STERILE AQUEOUSSUSPENS.

150MG/ML PHARMACIA N.V./S.A. BELGIUM

DEPRIM TABLETS N/A REMEDICA LTD CYPRUS

DEQUACAINE LOZENGE N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

DEQUADIN LOZENGE 0.25MG CROOKES HEALTHCARELIMITED

UNITED KINGDOM

DERM-AID CREAM 5MG/G EGO PHARMACEUTICALS AUSTRALIA

DERMAID SOFT 0.5% CREAM CREAM 0.5% EGO PHARMACEUTICALSPTY LTD.

AUSTRALIA

DERMAID SOFT 1% CREAM CREAM 1% EGO PHARMACEUTICALSPTY LTD.

AUSTRALIA

DERMATIN SHAMPOO 20MG/ML DELTA HF ICELAND

DERMESONE CREAM N/A DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

DERMESONE SKIN OINTMENT 1MG/G DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

DERMIDEX DERMATOLOGICALCREAM

CREAM N/A PHARMALAB LTD UNITED KINGDOM

DERMOBACTER SOLN FOR CUTANEOUSAPPLIC

N/A INNOTECHINTERNATIONAL

FRANCE

DERMOCINETIC CREAM N/A GEYMONAT SPA ITALY

DERMOVATE CREAM CREAM 0.053% W/W GLAXO WELLCOME UKLTD T/A GLAXO LABSS

UNITED KINGDOM

DERMOVATE CREAM CREAM 0.05%W/W GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

DERMOVATE OINTMENT OINTMENT 0.05% W/W GLAXO WELLCOME UKLTD

UNITED KINGDOM

DERMOVATE OINTMENT OINTMENT 0.05%W/W GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

DERMOVATE SCALPAPPLICATION

SOLUTION FOR TOPICALUSE

0.5MG/G GLAXO WELLCOMEGMBH & CO

GERMANY

DERMOVATE SCALPAPPLICATION

TOPICAL SOLUTION 0.05%W/W GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

EL526 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DERMOVATE SCALPAPPLICATION 0.05%

SOLTN. FOR SCALP APPL. 0.05% W/W GLAXO WELLCOMEGMBH & CO

GERMANY

DESAL 40MG 50 TABLET TABLET 40MG BIOFARMA ILAC SAN. VETIC.A.S.

TURKEY

DESFERAL SUBSTANCE FORINJECTION

500MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

DESFERAL DRY SUBSTANCE FORINJ.

500MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

DESFERAL SOLUTION FORINJECTION

500MG NOVARTIS PHARMAGMBH

GERMANY

DE-SPASM 135MG FILM COATEDTABLETS

FILM COATED TABLETS 135MG ELSAAD PHARMA —SYRIA

SYRIA

DETACORTIL ENTERIC COATEDTABLET

5MG PFIZER LIMITED UNITED KINGDOM

DETADERM NM CREAM NA ATCO LABORATORIES(PVT) LTD

PAKISTAN

DETIMEDAC POWDER F/SOLN FOR IVINJ

200MG/VIAL GESELLSCHAFT FURKLINISCHESPEZIALPREPARATE MBH

GERMANY

DETRUSITOL FILM COATED TABLET 1MG PHARMACIA & UPJOHNS.P.A.

ITALY

DETRUSITOL FILM COATED TABLET 2MG PHARMACIA & UPJOHNS.P.A.

ITALY

DETRUSITOL FILM-COATED TABLETS 1MG PHARMACIA ITALIA SPA ITALY

DETRUSITOL FILM-COATED TABLETS 2MG PHARMACIA ITALIA SPA ITALY

DETTOL ANTISEPTIC CREAM CREAM N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

DEXA RHINASPRAY N NASAL SPRAY SOLUTION N/A BOEHRINGER INGELHEIMELLAS A.E

GREECE

DEXA-GENTAMICIN EYE OINTMENT N/A URSAPHARMARZNEIMITTEL GMBH

GERMANY

DEXA-GENTAMICIN EYE DROPS N/A URSAPHARMARZNEIMITTEL GMBH

GERMANY

DEXAMED 0.5MG TABLET 0.5MG MEDOCHEMIE LTD CYPRUS

DEXAMED 1.5MG TABLET 1.5MG MEDOCHEMIE LTD CYPRUS

DEXAMED 8MG/2ML LIQUID FOR INJECTION 8MG/2ML MEDOCHEMIE LTD CYPRUS

DEXAMETHASONE PHOSPHATEINJECTION

SOLUTION FORINJECTION

8MG/2ML F.H. FAULDING & CO.LTD (T/A DAVID BULLLABS)

UNITED KINGDOM

DEXAMETHASONE SODIUMPHOSPHATE

SOL. FOR INJ. 8MG/2ML EGYPTIANINTERNATIONALPHARMACEUTICALINDUSTRIES CO.

EGYPT

DEXAMETHASONE SODIUMPHOSPHATE

SOLUTION FORINJECTION

4MG/ML CIPLA LTD INDIA

DEXAMETHASONE/GAP INJECTABLE SOLUTION 8MG/2ML GAP S.A. GREECE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 527

Trade Name Dosage Form Dose MA Holder Country

DEXAMYTREX EYE DROPS EYE DROPS N/A DR.GERHARD MANN,CHEM.-PHARM. FABRIKGMBH

GERMANY

DEXAMYTREX EYE OINTMENT EYE OINTMENT N/A DR. GERHARD MANN,CHEM.-PHARM. FABRIKGMBH

GERMANY

DEXA-RHINOSPRAY PUMP SPRAY N/A BOEHRINGER INGELHEIMPHARMA KG

GERMANY

DEXTRAN 40 10% W/V INDEXTROSE 5% W/V

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTRAN 40 10% W/V IN NACL0.9% W/V

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTRAN 40 IV INFUSION INSODIUM CHLOR.

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

DEXTRAN 70 6% W/V INDEXTROSE 5% W/V

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTRAN 70 6%W/V IN NACL0.9%W/V

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE SOLUTION FORINJECTION

10% W/V BP GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

DEXTROSE 10% W/V SOL. FOR INJ./INF. 10% W/V PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE 20% W/V SOL. FOR INJ./INF. 20%W/V PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE 3.33% W/V IN NACL0.3% W/V

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE 30% W/V SOL. FOR INJ./INF. 30%W/V PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE 4% W/V IN NACL0.18% W/V

SOL. FOR INJ./INF N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE 5% (W/V) SOL. FOR INJ./INFUSION 5%W/V PARACELCIA INDUSTRIAFARMACEUTICA SA

PORTUGAL

DEXTROSE 5% W/V IN NACL 0.3%W/V

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE 5% W/V IN NACL 0.9%W/V

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE 5%W/V IN NACL0.15%W/V

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE 5%W/V IN NACL 0.45%W/V

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

DEXTROSE 50% SOLUTION FORINJECTION

25G/50ML PHARMAMEDPARENTERALS LTD.

MALTA

DEXTROSE 50% HYPERTONICAGUETTANT

INJECTABLE SOLUTION 50% LABORATOIREAGUETTANT

FRANCE

DEXTROSE DEMO 20% SOLUTION FOR IVINFUSION

20% W/V DEMO SA GREECE

DEXTROSE INFUSIONSOLUTION/DEMO 5%

SOLUTION FORINFUSION

N/A DEMO ABEE GREECE

EL528 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DEXTROSE SOLN F/INFUSIONDEMO

SOLUTION FORINFUSION

5% DEMO SA GREECE

DEXTROSE SOLUTION FORINFUSION DEMO 10%

SOLUTIONFOR INFUSION 10% DEMO SA GREECE

DEXTROSE/DEMO 35% SOLUTION FORINJECTION

N/A DEMO SA GREECE

DEZOR CREAM N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

DEZOR SHAMPOO 2% W/V HOE PHARMACEUTICALSSDN BHD

MALAYSIA

DEZOR CREAM N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

DEZOR SHAMPOO LIQUID N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

DEZOR SHAMPOO SHAMPOO 2% W/V HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

DHC CONTINUS TABLETS 120MG MODIFIED RELEASETABLET

120MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

DHC CONTINUS TABLETS 90 MG MODIFIED RELEASETABLET

90MG NAPP LABORATORIIESLIMITED

UNITED KINGDOM

DHC-CONTINUS TABLETS 60MG MODIFIED RELEASETABLETS

60MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

DIA COLON SYRUP 66.7G/100ML VECCHI & C PIAMS.A.P.A.

ITALY

DIABENESE TABLET 250MG PFIZER UNITED KINGDOM

DIABINESE TABLETS 100MG PFIZER LIMITED UNITED KINGDOM

DIABITOL TABLET 5MG TABLET 5MG SM PHARMACEUTICALSSDN BHD

MALAYSIA

DIAGLIC TABLET 80MG OKAS PHARMA PVT LTD— INDIA

INDIA

DIAMICRON TABLETS 80MG SERVIER PAKISTAN

DIAMICRON TABLETS 80MG SERVIER EGYPTINDUSTRIES LTD

EGYPT

DIAMICRON 80MG SCORED TABLET 80MG LES LABORATOIRESSERVIER

FRANCE

DIAMICRON 80MG TABLET 80MG LABORATORIOSSERVIER, S.A.

SPAIN

DIAMICRON MR MODIFIED RELEASETABLET

30MG LES LABORATOIRESSERVIER

FRANCE

DIAMICRON TABLET TABLET 80MG SERVIER PAKISTAN

DIAMORPHINE HYDROCHLORIDEBP

POWDER FORRECONSTITUTION

500MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM

DIAMORPHINE HYDROCHLORIDEBP

POWDER FORRECONSTITUTION

30MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM

DIAMORPHINE HYDROCHLORIDEBP

POWDER FORRECONSTITUTION

10MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 529

Trade Name Dosage Form Dose MA Holder Country

DIAMORPHINE HYDROCHLORIDEBP

POWDER FORRECONSTITUTION

5MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM

DIAMORPHINE HYDROCLORIDEBP

POWDER FORRECONSTITUTION

100MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM

DIAMOX TABLET 250MG LEDERLE PAKISTAN

DIAMOX TABLET 250MG WYETH-LEDERLE PAKISTAN

DIAMOX TABLET 250MG CYANAMID OF GREATBRITAIN LTD

UNITED KINGDOM

DIAMOX SODIUM PARENTERAL POWDER FOR INJECTION 500MG/VIAL CYANAMID OF GREATBRITAIN LTD

UNITED KINGDOM

DIANE 35 TABLET NA SCHERING PAKISTAN

DIANE-35 COATED TABLET N/A SCHERING AG GERMANY

DIANEAL PD1 1,36% SOLUTION FORINJECTION

NA SALUS SLOVENIA

DIANEAL PD1 GLUCOSE 1.36% SOLUTION FORINJECTIONS

13.6MG/1ML BAXTER HEALTHCARELIMITED

UNITED KINGDOM

DIANEAL PD1 GLUCOSE2.27%W/V

SOLUTION FORINJECTION

22.7MG/1ML BAXTER HEALTHCARELIMITED

UNITED KINGDOM

DIANEAL PD1 GLUCOSE3.86%W/V

SOLUTION FORINJECTION

38.6MG/ML BAXTER HEALTHCARELIMITED

UNITED KINGDOM

DIANEAL PD4 PERIT. DIALYSISSOL. 1.36

SOL. F/INTRAPERITONEAL AD

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

DIANEAL PD4 PERIT. DIALYSISSOL. 2.27

SOL. F/INTRAPERITONEAL AD

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

DIANEAL PD4 PERIT. DIALYSISSOL. 3.86

SOL. F/INTRAPERITONEAL AD

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

DIARREST SYRUP ORAL SOLUTION N/A GALEN LIMITED UNITED KINGDOM

DIAZEM 60MG TABLET 60MG MEDOCHEMIE LTD CYPRUS

DIAZEPAM TABLET 5MG RANBAXY IRELANDLIMITED

IRELAND

DIAZEPAM TABLETS 50MG PHARMAMED LTD. MALTA

DIAZEPAM BP 10MG TABLET 10MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

DIAZEPAM BP 2MG TABLET 2MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

DIAZEPAM BP 5MG TABLET 5MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

DIAZEPAM DESITIN RECTAL SOLUTION 5MG DESITIN ARZNEIMITTELGMBH

GERMANY

DIAZEPAM INJECTION BP SOLUTION FORINJECTION

5MG/ML CP PHARMACEUTICALSLTD.)

UNITED KINGDOM

DIAZEPAM INJECTION BP SOLUTION FORINJECTION

0.5% W/V PHOENIXPHARMACEUTICALS LTD

UNITED KINGDOM

EL530 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DIAZEPAM INJECTION BP 5MG/ML SOLUTION FORINJECTION

5MG/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

DIAZEPAM RECTAL TUBES 10MG RECTAL SOLUTION 4MG/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

DIAZEPAM RECTAL TUBES 10MG RECTAL SOLUTION 10MG / TUBE CP PHARMACEUTICALSLTD

UNITED KINGDOM

DIAZEPAM RECTAL TUBES 2.5MG RECTAL SOLUTION 2MG/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

DIAZEPAM RECTAL TUBES 5MG RECTAL SOLUTION 2MG/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

DIAZEPAM RECTAL TUBES 5MG RECTAL SOLUTION 5MG / TUBE CP PHARMACEUTICALSLTD

UNITED KINGDOM

DIAZOL SUSPENSION 320MG/5ML ATCO LABORATORIES(PVT) LTD

PAKISTAN

DIAZOL TABLETS 200MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

DIAZOL TABLETS 400MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

DIBENYLINE CAPSULES 10MG CAPSULE 10MG FORLEY LIMITED UNITED KINGDOM

DICALCI SOFT CAPSULES 1MCG KOREA UNITED PHARM.INC.

KOREA REPUBLIC

DICETEL 100MG FILM-COATED TABLET 100MG LABORATOIRES SOLVAYPHARMA

FRANCE

DICETEL 50MG FILM-COATED TABLET 50MG LABORATOIRES SOLVAYPHARMA

FRANCE

DICLAC 50 ENTERIC-COATEDTABLET

50MG HEXAL AG GERMANY

DICLO 25 TABLET ENTERIC-COATEDTABLET

25MG CAMDEN INDUSTRIES (M)SDN. BHD.

MALAYSIA

DICLO-DENK 100 RECTAL SUPPOSITORIES 100MG E. DENK OHG GERMANY

DICLO-DENK 100 RETARD TABLETS 100MG E. DENK OHG GERMANY

DICLO-DENK 50 ENTERIC COATEDTABLET

50MG E. DENK OHG GERMANY

DICLOFENAC SUPPOSITORIES 50MG GLAXO WELLCOMEPOZNAN S.A.

POLAND

DICLOFENAC SUPPOSITORIES 100MG GLAXO WELLCOMEPOZNAN S.A.

POLAND

DICLOFENAC GASTRO-RESISTANTTABLETS

TABLETS 25MG PHARMAMED LTD. MALTA

DICLOFENACRETARD-RATIOPHARM

PROLONGED RELEASECAPSULE

100MG RATIOPHARM GMBH GERMANY

DICLOFENAC SODIUM OPHTHALMIC SOLUTION 0.1% W/V ALCON LABORATORIESINC.

UNITED STATES OFAMERICA

DICLOFENAC SODIUM ENTERIC COATEDTABLETS

25MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

DICLOFENAC SODIUM ENTERIC COATEDTABLETS

50MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 531

Trade Name Dosage Form Dose MA Holder Country

DICLOFENAC SODIUM TABLET 25MG DEXCEL-PHARMALIMITED

UNITED KINGDOM

DICLOFENAC SODIUM SOLUTION FORINJECTION

75MG/3ML PHARMAMEDPARENTERALS LTD.

MALTA

DICLOFENAC SODIUM ECTABLETS 25MG

GASTRO-RESISTANTTABLET

25MG GENERICS (UK) LIMITED UNITED KINGDOM

DICLOFENAC SODIUM ECTABLETS 25MG

GASTRO-RESISTANTTABLET

25MG GENERICS (UK) LIMITED UNITED KINGDOM

DICLOFENAC SODIUM TABLETS25MG

GASTRO-RESISTANTTABLET

25MG SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

DICLOFENAC SODIUM TABLETS50MG

TABLET 50MG SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

DICLOFENAC SR 100MG MODIFIED RELEASETABLET

100MG SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

DICLOFENAC SR 75MG MODIFIED RELEASETABLET

75MG SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

DICLOFENAC STADA 100RETARD

SUSTAINED RELEASETABLETS

100MG STADAPHARM GMBH GERMANY

DICLOFENAC STADA 100RETARD

SUSTAINED RELEASETABLETS

100MG STADAPHARM GMBH GERMANY

DICLOFENAC STADA 50 FILM COATED TABLETS 50MG STADAPHARM GMBH GERMANY

DICLOFENAC STADA N INJECTABLE SOLUTION 75MG STADAPHARM GMBH GERMANY

DICLOFENAC-RATIOPHARM 100ZAPFCHEN

SUPPOSITORY 100MG RATIOPHARM GMBH GERMANY

DICLOFENAC-RATIOPHARM 25TABLETTEN

GASTRO-RESISTANTTABLET

25MG RATIOPHARM GMBH GERMANY

DICLOFENAC-RATIOPHARM 50TABLETTEN

GASTRO-RESISTANTTABLET

50MG RATIOPHARM GMBH GERMANY

DICLOFENAC-RATIOPHARM UNO SUSTAINED RELEASETABLET

150MG RATIOPHARM GMBH GERMANY

DICLOGESIC SUPPOSITORES 50MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

DICLOGESIC EYE DROPS 5MG/5ML DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

DICLOGESIC 100 SUPPOSITORIES SUPPOSITORIES 100MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

DICLOGESIC 12.5 SUPPOSITORIES SUPPOSITORIES 12.5MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

DICLOGESIC 25 ENTERIC COATEDTABLETS

25MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

DICLOMELAN FILM COATED TABLETS 50MG LANNACHER HEILMITTELGES.M.B.H.

AUSTRIA

EL532 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DICLOMELAN SUPPOSITORY 100MG LANNACHER HEILMITTELGMBH

AUSTRIA

DICLOMELAN RETARD FILM COATED TABLETS 100MG LANNACHER HEILMITTELGES.M.B.H.

AUSTRIA

DICLORAN SR FILM COATED TABLET 100MG LEKAR PHARMA LIMITED INDIA

DICLORENGEL GEL 1%W/W TRIMA ISRAELPHARMACEUTICALPRODUCTS LIMITED

ISRAEL

DICLOXIL 250 CAPSULES 250MG AEGIS LTD CYPRUS

DICLOXIL 500 CAPSULES 500MG AEGIS LTD CYPRUS

DICORTEN CREAM 0.05%W/W TRIMA ISRAELPHARMACEUTICALPRODUCTS LIMITED

ISRAEL

DICTON COUGH SYRUP SYRUP 220MG/100ML DOLORGIET GMBH & COKG

GERMANY

DICTON COUGH CAPSULES RETARD CAPSULE 30MG DOLORGIET GMBH & CO.KG

GERMANY

DICTON COUGH RETARDCAPSULES

RETARD CAPSULES 30MG DOLORGIET GMBH & COKG

GERMANY

DICTON COUGH SYRUP SOLUTION 220MG/100ML DOLORGIET GMBH & CO.KG

GERMANY

DICYNONE 250 TABLET 250MG OM PHARMA SA SWITZERLAND

DICYNONE 500 TABLET 500MG OM PHARMA SA SWITZERLAND

DIDRALIN TABLET 50MG MEDOCHEMIE LTD CYPRUS

DIESPOR POWDER FOR INJECTION 1000MG BIOMEDICA FOSCAMAINDUSTRIA CHIMICOFARMACEUTICA S.P.A

ITALY

DIFENAC TABLETS 25MG TABLET 25MG DRUG HOUSES OFAUSTRALIA(ASIA) PTELTD

SINGAPORE

DIFFERIN CREAM 0.1% GALDERMA(UK) LIMITED UNITED KINGDOM

DIFFLAM COUGH LOZENGES N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DIFFLAM ANTI-INFLAMMATORYLOZENGES

LOZENGES N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DIFFLAM 5% GEL GEL 5% W/W 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DIFFLAM ANTI-INFLAMMATORYLOZENGES

LOZENGE N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DIFFLAM BLACKCURRANT S.F.COUGH LOZENGES

LOZENGES N/A 3M PHARMACEUTICALSPTY LTD.

AUSTRALIA

DIFFLAM CREAM CREAM 3% W/W 3M HEALTH CARELIMITED

UNITED KINGDOM

DIFFLAM HONEY AND LEMONSUGAR FRE

LOZENGES NA 3M PHARMACEUTICALSLIMITED

AUSTRALIA

DIFFLAM LOZENGES RASBERRYSUGAR FREE

LOZENGES N/A 3M PHARMACEUTICALSLIMITED

AUSTRALIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 533

Trade Name Dosage Form Dose MA Holder Country

DIFFLAM MOUTH GEL GEL N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DIFFLAM ORAL RINSE GARGLE 0.15% W/V 3M HEALTH CARELIMITED

UNITED KINGDOM

DIFFLAM ORANGE SUGAR FREE LOZENGES NA 3M PHARMACEUTICALSLIMITED

AUSTRALIA

DIFFLAM SPRAY 0.15%W/V OROMUCOSAL SPRAY 0.15% W/V 3M HEALTH CARELIMITED

UNITED KINGDOM

DIFFLAM-C ANTI-INFLAMMATORYANTISEPTIC

SOLUTION N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DIFFLAM-C ANTI-INFLAMMATORYANTISEPTIC

SOLUTION N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DIFLERIX 2.5MG CAPSULE 2.5MG MEDOCHEMIE LTD CYPRUS

DIFLUCAN CAPSULE 150MG PFIZER UNITED KINGDOM

DIFLUCAN CAPSULE 200MG PFIZER LIMITED UNITED KINGDOM

DIFLUCAN CAPSULE 50MG PFIZER LIMITED UNITED KINGDOM

DIFLUCAN INTAVENOUS SOLUTION N/A PFIZER LIMITED UNITED KINGDOM

DIFLUCAN INTAVENOUS SOLUTION N/A PFIZER LIMITED UNITED KINGDOM

DIFLUCAN POWDER FOR ORALSUSPENS.

50MG/5ML PFIZER LIMITED UNITED KINGDOM

DIFLUCAN POWDER FOR ORALSUSPEN.

N/A PFIZER LIMITED UNITED KINGDOM

DIGESTIVO ANTONETTO TABLETS N/A MARCO ANTONETTOSPA

ITALY

DIGESTIVO ANTONETTO TABLET N/A MARCO ANTONETTOSPA

ITALY

DIGIBIND DIGOXIN ANTIBODY(F(AB))

POWDER FOR INJECTION 38MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

DIGOXIN SOLUTION FORINJECTION

0.5MG/2ML PHARMAMEDPARENTERALS LTD.

MALTA

DIGOXIN INJECTION USP SOLUTION FORINJECTION

0.25MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

DIGOXIN TABLETS B.P. 0.25MG UNCOATED TABLET 0.25MG MEDICORPTECHNOLOGIES INDIALTD

INDIA

DIHYDERGOT NASAL SPRAY 4MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

DIHYDROCODEINE TABLETS 30MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

DIHYDROCODEINE 30MG TABLET 30MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

DIHYDROCODEINE TABLETS30MG

TABLETS 30MG GENERICS (UK) LIMITED UNITED KINGDOM

DIHYDROCODEINE TABLETS BP30MG

TABLETS 30MG CP PHARMACEUTICALS UNITED KINGDOM

EL534 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DIHYDROCODEINE TABLETS BP30MG

TABLET 30MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

DILAPAN CAPSULES 150MG REMEDICA LTD CYPRUS

DILAPROST 5MG 30 FILMCOATED TABLET

FILM-COATED TABLET 5MG BIOFARMA ILAC SAN.VETIC. A.S.

TURKEY

DILATREND TABLETS 12.5MG ROCHE DIAGNOSTICSGMBH

GERMANY

DILATREND 25MG TABLET 25MG HOFFMANN-LA ROCHEAG

GERMANY

DILATREND 6.25MG TABLET 6.25MG HOFFMANN-LA ROCHEAG

GERMANY

DILGARD TABLET 60MG CIPLA LTD. INDIA

DILTIAZEM HCL MODIFIEDRELEASE

TABLETS 60MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

DILTIAZEM HYDROCHLORIDETABLETS 60MG

MODIFIED RELEASETABLET

60MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

DILTIAZEM HYDROCHLORIDETABLETS BP 60MG

TABLETS 60MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

DILTIZEM TABLET 30 MG MUSTAFA NEVZAT ILACSANAYII A.S.

TURKEY

DILTIZEM TABLET 60MG MUSTAFA NEVZAT ILACSANAYII A.S.

TURKEY

DILZACARD 60 MG TABLETS TABLETS 60MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

DIMA 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

DINDEVAN TABLET 50MG GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

DINEX-100 TABLET 100MG CIPLA LIMITED INDIA

DINIKET SOLUTION FORINFUSION

10MG SCHWARZ PHARMAS.P.A.

ITALY

DIOCALM TABLETS N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

DIOCIMEX TABLETS 100MG CIMEX AG SWITZERLAND

DIORALYTE (BLACKCURRANT)POWDER

POWDER FOR ORALSOLUTION

N/A RORERPHARMACEUTICALSLIMITED T/A RPR FAMILYHEALTH DIVISION

UNITED KINGDOM

DIORALYTE NATURAL POWDER FOR ORALSOLUTION

N/A RORERPHARMACEUTICALSLIMITED

UNITED KINGDOM

DIORALYTE RELIEF POWDER FOR ORALSOLUTION

N/A MAY & BAKER LIMITED(T/A RHONE-POULENCRORER)

UNITED KINGDOM

DIORALYTE SACHETS FORSOLUTION (CITRUS)

POWDER FOR ORALSOLUTION

N/A RORERPHARMACEUTICALS LTD.T/A RPR FAMILY HEALTHDIVISION

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 535

Trade Name Dosage Form Dose MA Holder Country

DIOSPER FILM COATED TABLETS NA KLEVA LIMITED GREECE

DIOVAN CAPSULES 80MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

DIOVAN CAPSULES 160MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

DIOVAN FILM COATED TAB 80MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

DIOVAN FILM COATED TABLET 160MG NOVARTIS PHARMASCHWIEZ AG

SWITZERLAND

DIOVAN FILM-COATED TABLETS 160 MG NOVARTISFARMACEUTICA S.A. —SPAIN

SPAIN

DIOVAN FILM-COATED TABLETS 80MG NOVARTISFARMACEUTICA S.A. —SPAIN

SPAIN

DIOVENOR FILM-COATED TABLETS 600MG LABORATOIRESINNOTHERA

FRANCE

DIPALAN 150 CAPSULES 150MG REMEDICA LTD CYPRUS

DIPENTUM CAPSULES 250MG PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

DIPENTUM TABLET 500 MG TABLET 500MG PHARMACIA SVERIGE AB SWEDEN

DIPHENHYDRAMINE CO COUGHLINCT. 14MG/5ML

ORAL SOLUTION N/A ROSEMONTPHARMACEUTICALSLIMITED

UNITED KINGDOM

DIPHENHYDRAMINE CO COUGHLINCTUS

ORAL SOLUTION 14MG/5ML ROSEMONTPHARMACEUTICALS LTD.

UNITED KINGDOM

DIPHTERIA AND TETANUSVACCINE (ADSORBED)

SOLUTION FORINJECTION

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

DIPHTERIA AND TETANUSVACCINE ADSORBED

SOLUTION FORINJECTION

0.5ML/DOSE SERUM INSTITUTE OFINDIA LTD

INDIA

DIPHTERIA AND TETANUSVACCINE PEDIATRIC

SOLUTION FORINJECTION

N/A M/S SERUM INSTITUTEOF INDIA

INDIA

DIPHTERIA-TETANUS-PERTUSSISVACCINE ADS.

SOLUTION FORINJECTION

N/A M/S SERUM INSTITUTEOF INDIA LIMITED

INDIA

DIPHTHERIA-TETANUS-PERTUSSISVACCINE

SOLUTION FORINJECTION

NA SERUM INSTITUTE OFINDIA LTD

INDIA

DIPHTHERIA AND TETANUSVACCINE ADSORBED

SOLUTION FORINJECTION

N/A SERUM INSTITUTE OFINDIA LTD

INDIA

DIPHTHERIA VACCINE(ADSORBED)

SOLUTION FORINJECTION

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

DIPRIVAN EMULSION FORINJECTION

1% W/V ZENECA LIMITED UNITED KINGDOM

DIPRIVAN EMULSION FORINJECTION

20MG/ML ZENECA LIMITED UNITED KINGDOM

DIPRIVAN 2% EMULSION FORINJECTION

20MG / ML ZENECA LIMITED UNITED KINGDOM

DIPROPHOS/DIPROFOS SOLUTION FORINJECTION

N/A SCHERING-PLOUGH S.A. BELGIUM

EL536 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DIPROSALIC OINTMENT N/A SCHERING-PLOUGHNV/SA

BELGIUM

DIPROSALIC LOTION N/A SCHERING-PLOUGH S.A. BELGIUM

DIPROSONE CREAM 0.64MG/G SCHERING-PLOUGHNV/SA

BELGIUM

DIPROSONE OINTMENT 0.64MG/G SCHERING-PLOUGHNV/SA

BELGIUM

DIPROSONE LOTION 0.64MG/G SCHERING-PLOUGHNV/SA

BELGIUM

DIPYRIDAMOLE TABLETS 25MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

DIPYRIDAMOLE TABLETS 100MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

DIPYRIDAMOLE COATED TABLET 100MG GENERICS(UK) LIMITED UNITED KINGDOM

DISFLATYL DROPS ORAL EMULSION 40MG/ML SOLCO BASLE LTD. SWITZERLAND

DISFLATYL TABLETS CHEWABLE TABLETS 40MG SOLCO BASLE LTD. SWITZERLAND

DISIPAL TABLETS 50MG YAMANOUCHI PHARMAB.V.

NETHERLANDS

DISOPHROL SUSTAINED-ACTIONTABLETS

N/A SCHERING-PLOUGHCORPORATION

UNITED STATES OFAMERICA

DISOPYRAMIDE PHOSPHATECAPSULES BP 100MG

CAPSULE 100MG GENERICS[UK] LIMITED UNITED KINGDOM

D-ISO-RATIOPHARM SACHET N/A RATIOPHARM GMBH GERMANY

DISPERSIBLE ASPIRIN TABLET 75MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

DISPRIN TABLETS TABLET 300MG RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

DISPROL PARACETAMOLSUSPENSION

SUSPENSION 120MG/5ML RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

DISPROL SOLUBLEPARACETAMOL TABLETS

TABLET 120MG RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

DISTALGESIC TABLETS COATED TABLET N/A ELI LILLY & COMPANYLIMITED

UNITED KINGDOM

DISTILLED WITCH HAZEL BPC1973

TOPICAL SOLUTION 100% V/V BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

DITROPAN SCORED TABLET 5MG LABORATOIRESSYNTHELABO

FRANCE

DITROPAN ELIXIR 2.5MG/5ML SYRUP 2.5MG/5ML LOREX SYNTHELABO UK& IRELAND LIMITED

UNITED KINGDOM

DITROPAN XL MODIFIED RELEASETABLETS

15MG SANOFI WINTHROP LTDT/A SANOFISYNTHELABO

UNITED KINGDOM

DITROPAN XL MODIFIED RELEASETABLETS

5MG SANOFI WINTHROPLIMITED T/A SANOFISYNTHELABO

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 537

Trade Name Dosage Form Dose MA Holder Country

DITROPAN XL MODIFIED RELEASETABLETS

10MG SANOFI WINTHROP LTDT/A SANOFISYNTHELABO

UNITED KINGDOM

DIUMIDE-K CONTINUS TABLETS MODIFIED RELEASETABLETS

N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

DIUREMID 20MG INJECTION SOLUTION FORINJECTION

20MG HOVID SDN BHD MALAYSIA

DIVIDOL TABLETS 10MG REMEDICA LTD. CYPRUS

DIVIR-100 TABLETS 100MG CIPLA LIMITED INDIA

DNCG STADA AUGENTROPFEN SOLUTION 20MG/ML STADAPHARM GMBH GERMANY

DOBUJECT 50MG/ML CONC. FOR PARENT.INFUS.

50MG/ML LEIRAS OY FINLAND

DOBUTAMINE INJECTION SOLUTION FORINJECTION

12.5MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

DOBUTREX LIQUID CONC FORINF

CONC. FOR INF. 250MG/VIAL LILLY DEUTSCHLANDGMBH

GERMANY

DOBUTREX SOLUTION CONCENTRATE FORINFUSION

250MG/20ML LILLY DEUTSCHLANDGMBH

GERMANY

DOCUSATE CALCIUM CAP 240MG CAPSULE 240MG TAROPHARMACEUTICALS INC.

CANADA

DOCUSATE SOD CAP 100MG CAPSULE 100MG TAROPHARMACEUTICALS INC.

CANADA

DOGMATIL 200MG TABLET 200MG LABORATOIRESSYNTHELABO

FRANCE

DOGMATIL 50MG CAPSULE 50MG LABORATOIRESSYNTHELABO

FRANCE

DOLAL LINIMENT N/A LABORATOIRESBIOCODEX

FRANCE

DOLGIT 600 SUGAR COATEDTABLETS

600MG DOLORGIET GMBH & CO.KG

GERMANY

DOLGIT CREAM CREAM 5G/100G DOLORGIET GMBH & CO.KG

GERMANY

DOLGIT CREAM CREAM 5G/100G DOLORGEIT GMBH &COKG

GERMANY

DOLOBENE GEL N/A MEPHA PHARMA AG SWITZERLAND

DOLOBID 250MG TABLET 250MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

DOLOFEN-500 LACTAB 500MG MEPHA PHARMA AG SWITZERLAND

DOLO-GESIC FILM COATED TABLET 50MG ALFARESPHARMACEUTICALS

SYRIA

DOLO-GESIC, FILM-COATEDTABLET

FILM-COATED TABLET 50MG ALFARESPHARMACEUTICALS

SYRIA

DOLVAN TABLETS TABLETS N/A NORMA CHEMICALSLIITED

UNITED KINGDOM

DOMAR CAPSULE 5MG POLIPHARM CO. LTD. THAILAND

DONA CAPSULE 250MG ROTTAPHARM S.R.L. ITALY

EL538 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DONORMYL 15MG SCORED FILM-COATEDTABLET

15MG LABORATOIRES OBERLIN FRANCE

DONORMYL 15MG SCORED EFF. TABLETS 15MG LABORATOIRES OBERLIN FRANCE

DOPAMET 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

DOPAMINE 200 PIERRE FABRE200MG/5ML

INJ. SOL. FOR INFUSION 200MG/5ML PIERRE FABREMEDICAMENT

FRANCE

DOPAMINE 50 PIERRE FABRE50MG/10ML

INJECT. SOL. FORINFUSION

50MG/10ML PIERRE FABREMEDICAMENT

FRANCE

DOPAMINE CONC. SELECTAJET SOLUTION FORINJECTION

40MG/ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

DOPATAB M250 TABLET 250MG HOVID SDN BHD MALAYSIA

DOPEGYT TABLETS 250MG EGIS PHARMACEUTICALSLTD

HUNGARY

DOPERGIN TABLET 0.2MG LABORATOIRESCHERING

FRANCE

DOPERGIN TABLETS 0.2MG SCHERING PAKISTAN

DORMICUM FILM-COATED TABLET 7.5MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

DORMICUM AMPOULE 5MG/5ML ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

DORMONOCT TABLET 1MG HOECHST MARIONROUSSEL LIMITED

UNITED KINGDOM

DORYX 100 CAPSULE 100MG FAULDINGPHARMACEUTICALS

AUSTRALIA

DORYX 50 CAPSULE 50MG FAULDINGPHARMACEUTICALS

AUSTRALIA

DOSTINEX TABLETS 0.5MG PHARMACIA & UPJOHNS.P.A

ITALY

DOSTINEX TABLETS 0.5MG PHARMACIA & UPJOHNS.P.A

ITALY

DOTHIEPIN CAPSULES 25MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

DOTHIEPIN TABLETS 75MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

DOXAT 100 TABLETS F.C. 100MG AEGIS LTD CYPRUS

DOXAT 100 CAPSULE 100MG AEGIS LTD CYPRUS

DOXAT 50 TABLETS F.C. 50MG AEGIS LTD. CYPRUS

DOXEPIN HDROCHLORIDE CAPSULES 25MG DANBURY PHARMACALINC.

UNITED STATES OFAMERICA

DOXIBIOTIC CAPSULES 100MG CTS CHEMICALINDUSTRIES LTD

ISRAEL

DOXIBIOTIC CAPSULES 100MG CTS CHEMICALINDUSTRIES

ISRAEL

DOXIPROCT OINTMENT N/A LABORATOIRES OM S.A. SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 539

Trade Name Dosage Form Dose MA Holder Country

DOXIPROCT SUPPOSITORY N/A LABORATOIRES OM S.A. SWITZERLAND

DOXIPROCT PLUS OINMENT N/A LABORATOIRES OM S.A. SWITZERLAND

DOXIPROCT PLUS SUPPOSITORY N/A LABORATOIRES OM S.A. SWITZERLAND

DOXIUM TABLET 250MG LABORATOIRES OM S.A. SWITZERLAND

DOXIUM 500 CAPSULE 500MG LABORATOIRES OM S.A. SWITZERLAND

DOXIVENIL GEL N/A LABORATOIRES OM S.A. SWITZERLAND

DOXOLEM (WITHOUTMETHYLPARABEN)

POWDER FOR INJECTION 50MG/10ML LEMERY, S.A. DE C.V. MEXICO

DOXORUBICIN HCL FOR INJ. USPLYOPHILISED

LYOPHILISED CAKE FORINJ

10MG M/S SERUM INSTITUTEOF INDIA LIMITED

INDIA

DOXORUBICIN HYDROCHLORIDEINJ. VIAL

SOLUTION FORINJECTION

10MG/5ML F.H. FAULDING & CO.LTD. (T/A DAVID BULLLABS)

AUSTRALIA

DOXORUBICIN HYDROCHLORIDEINJECTION VIAL

SOLUTION FORINJECTION

50MG/25ML F.H. FAULDING & CO.LTD. (T/A DAVID BULLLABS)

AUSTRALIA

DOXORUBICIN HYDROCLORIDEINJ LYOPHILISED

LYOPHILISED CAKE FORINJ

50MG M/S SERUM INSTITUTEOF INDIA LIMITED

INDIA

DOXYCYCLIN STADA 100 FILM COATED TABLETS 100MG STADAPHARM GMBH GERMANY

DOXYCYCLINE CAPSULES 50MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

DOXYCYCLINE CAPSULES 100MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

DOXYCYCLINE TABLETS 100MG PHARMAMED LTD. MALTA

DOXYDAR 100 CAPSULES 100MG DAR AL SAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

DOXYHEXAL CAPSULE 100MG HEXAL AG GERMANY

DOXYHEXAL 200 CAPSULE 200MG HEXAL AG GERMANY

DOXYHEXAL TABS TABLET 100MG HEXAL AG GERMANY

DOXYLIN TABLET 50MG ALPHAPHARM PTYLIMITED

AUSTRALIA

DOXYLIN 100 TABLET 100MG ALPHAPHARM PTYLIMITED

AUSTRALIA

DOXYN CAPSULES 100MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

DRAMAMINE TABLETS 50MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

DRAPOLENE CREAM N/A GLAXO WELLCOMEGROUP

POLAND

DRAPOLENE CREAM CREAM N/A GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

DRICLOR TOPICAL SOLUTION 20% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

EL540 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DRIED FACTOR VIII FRACTION,TYPE 8Y,

POWDER FOR INJECTION N/A BPL, BIO PRODUCTSLABORATORY

UNITED KINGDOM

DRIN TABLETS N/A ALFA WASSERMANNS.P.A.

ITALY

DRIPTANE 5MG SCORED TABLET 5MG LABORATOIRES DEBAT FRANCE

DRISTAN NASALSPRAY 0.05% W / W WHITEHALLLABORATORIES LTD

UNITED KINGDOM

DRISTAN DECONGESTANT TABLETS N/A WHITEHALLLABORATORIES LTD

UNITED KINGDOM

DROPSTAR TG EYE DROPS NA FARMIGEA S.P.A. ITALY

DROPTIMOL OPHTHALMIC DROPS 0.5% W/V FARMIGEA SPA ITALY

DROPTIMOL OPHTHALMIC DROPS 0.25% W/V FARMIGEA SPA ITALY

D-STOP-RATIOPHARM FILM COATED TABLET 2MG RATIOPHARM GMBH GERMANY

DUAL LAX EXTRA STRONGTABLETS

COATED TABLETS N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

DUAL LAX NORMAL TABLETS COATED TABLET N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

DUBAM CREAM CREAM N/A NORMA CHEMICALSLIMITED

UNITED KINGDOM

DUBAM SPRAY AEROSOL SPRAY N/A NORMA CHEMICALSLIMITED

UNITED KINGDOM

DUINUM 50MG TABLET 50MG MEDOCHEMIE LTD CYPRUS

DUKORAL ORAL LIQ & EFF.GRANULES

NA SBL VACCIN AB SWEDEN

DULCOLAX S.C. TABLETS 5MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

DULCOLAX SUPPOSITORY 5MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

DULCOLAX SUPPOSITORY 10MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

DULCOLAX TABLET 5MG BOEHRINGER INGELHEIM PAKISTAN

DULCOLAX ENTERIC COATEDTABLET

5MG BOEHRINGER-INGELHEIM PAKISTAN

DUOFILM TOPICAL SOLUTION N/A STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

DUOGAS EFFERVESCENTGRANULES

N/A BRACCO S.P.A ITALY

DUPHALAC SYRUP 667G/L SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

DUPHALAC DRY POWDER >=95% W/W SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

DUPHASTON TABLET 10MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

DUPHASTON FILM-COATED TABLET 10MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 541

Trade Name Dosage Form Dose MA Holder Country

DURACEF SUSPENSION 5% W / V BRISTOL-MYERS SQUIBBS.P.A

ITALY

DURACEF CAPSULES 500MG BRISTOL-MYERS SQUIBBHOLDINGS LTD

ITALY

DURACEF POWDER FOR ORALSUSP.

500MG/5ML (10%) BRISTOL MYERS SQUIBBS.P.A.

ITALY

DURACEF SUSPENSION 5%(250MG/5ML) BRISTOL MYERS SQUIBBS.P.A.

ITALY

DURACEF SUSPENSION250MG/5ML

POWDER FOR ORALSUSPENSIO

250MG/5ML BRISTOL-MYERS SQUIBBHOLDINGS LTD

UNITED KINGDOM

DURAKINASE INJECTION POWDER FOR INJECTION 750000 UI DONG KOOK PHARM.CO. LTD

KOREA REPUBLIC

DURAKINASE INJECTION POWDER FOR INJECTION 1500000 IU DONG KOOK PHARM.CO. LTD

KOREA REPUBLIC

DUR-ELIX PLUS ORAL LIQUID NA 3M PHARMACEUTICALSLIMITED

AUSTRALIA

DUROAMINE CAPSULES 30MG MODIFIED RELEASECAPSULES

30MG 3M HEALTH CARELIMITED

UNITED KINGDOM

DUROGESIC 25MCG/H PATCH 25MCG/H JANSSEN-CILAG N.V. BELGIUM

DUROGESIC TTS 100MCG/H PATCH 100MCG/H JANSSEN-CILAG N.V. BELGIUM

DUROGESIC TTS 50MCG/H PATCH 50MCG/H JANSSEN-CILAG N.V. BELGIUM

DUROGESIC TTS 75MCG/H PATCH 75MCG/H JANSSEN-CILAG N.V. BELGIUM

DURO-TUSS COUGH LOZENGES LOZENGE N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DURO-TUSS COUGH LOZENGES LOZENGES N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DURO-TUSS DECONGESTANT ORAL LIQUID N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DURO-TUSS EXPECTORANT ORAL LIQUID N/A 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DURO-TUSS FORTE ORAL LIQUID 3MG/ML 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DURO-TUSS MUCOLYTIC COUGHLIQUID

ORAL LIQUID 0.8MG/ML 3M PHARMACEUTICALSLIMITED

AUSTRALIA

DURO-TUSS REGULAR ORAL LIQUID 1MG/ML 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

DURO-TUSS SINUS ORAL LIQUID N/A AUST R 54130 AUSTRALIA

DUSPATALIN LIQUID SUSPENSION 10MG/ML SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

DUXIL COATED TABLET N/A LES LABORATOIRESSERVIER

FRANCE

DUXIL ORAL SUSPENSION N/A LES LABORATOIRESSERVIER

FRANCE

DUXIMA IM VIAL 1G ECOBI FARMACEUTICIS.A.S

ITALY

DYAZIDE TABLETS TABLET N/A SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

EL542 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DYCLOMAX 100MG DELAYED RELEASETABLET

100MG SMITHKLINE BEECHAMPHARMA GMBH

GERMANY

DYCLOMAX 100MG SUPPOSITORY 100MG SMITHKLINE BEECHAMPHARMA GMBH

GERMANY

DYCLOMAX 50MG ENTERIC COATEDTABLET

50MG SMITHKLINE BEECHAMPHARMA GMBH

GERMANY

DYCLOMAX 75MG/3ML SOLUTION FORINJECTION

75MG/3ML SMITHKLINE BEECHAMPHARMA GMBH

GERMANY

DYNASTAT POWDER FOR SOLUTIONFOR INJECTION

20MG PHARMACIA EUROPEEEIG

EUROPEAN COMMUNITY

DYNASTAT POWDER FOR SOLUTIONFOR INJECTION

40MG PHARMACIA EUROPEEEIG

EUROPEAN COMMUNITY

DYSPAMET SUSPENSION ORAL SUSPENSION 4%W/V GOLDSHIELDPHARMACEUTICALSLIMITED

UNITED KINGDOM

DYSPAMET SUSPENSION200MG/5ML

ORAL SUSPENSION 200MG/5ML SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

DYSPORT INJECTION POWDER FOR INJECTION 500 UNITS IPSEN LIMITED UNITED KINGDOM

E45 CREAM CREAM N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

E45 ITCH RELIEF CREAM CREAM N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

EAREX EAR DROPS EAR DROPS N/A PHARMALAB LTD UNITED KINGDOM

EAU PRECIEUSE TOPICAL SOLUTION N/A PARKE-DAVIS FRANCE

EBRILON TABLETS 250MG MEDOCHEMIE LTD CYPRUS

ECHINACEA TABLETS COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

ECOCAIN SOLUZIONE INIETTABILE 20MG/ML MOLTENI DENTAL SRL ITALY

ECOCAIN 8704 FLAC. NEBULIZZATORE NS MOLTENI DENTAL SRL ITALY

ECOCAIN A50 SOLUTION FORINJECTION

N/A MOLTENI DENTAL S.R.L. ITALY

ECOCAIN A80 SOLUTION FORINJECTION

N/A MOLTENI DENTAL S.R.L. ITALY

ECOCAIN CON ADRENALINA1:100,000

SOLUZIONE INIETTABILE 20MG/ML MOLTENI DENTAL SRL ITALY

ECOCAIN CON ADRENALINA1:80,000

SOLUZIONE INIETTABILE 20MG/ML MOLTENI DENTAL SRL ITALY

ECOCILLIN CAPSULE MOLLIVAGINALI

NA PROGE FARM S.R.L. ITALY

ECOCILLIN, CAPSULE MOLLIVAGINALI

CAPSULE MOLLIVAGINALI

100000000 UFF PROGE FARM S.R.L ITALY

ECOCORT CREAM N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

ECOCORT CREAM CREAM N/A HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

ECODERGIN VAGINAL CREAM 1% W/W FARMIGEA SPA ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 543

Trade Name Dosage Form Dose MA Holder Country

ECODERGIN VAGINAL OVULE 150MG FARMIGEA SPA ITALY

ECODERGIN CREAM NA FARMIGEA SPA ITALY

ECOMI' VAGINAL OVULES 150MG GEYMONAT SPA ITALY

ECOMI' TOPICAL SOLUTION N/A GEYMONAT SPA ITALY

ECOMI' CREAM N/A GEYMONAT SPA ITALY

ECONEX-400 TABLETS N/A MACLEODSPHARMACEUTICALS LTD

INDIA

ECONEX-800 TABLET N/A MACLEODSPHARMACEUTICALS LTD

INDIA

ECOX-800 TABLET 800MG MACLEODS INDIA

EDRONAX TABLETS 4MG PHARMACIA & UPJOHNS.P.A

ITALY

EDRONAX TABLETS 4MG PHARMACIA ITALIA S.P.A ITALY

EFEXOR TABLETS 37.5MG LEDERLE PAKISTAN

EFEXOR — TAB 50 MG TABLETS 50MG WYETH-AYERSTCANADA INC.

CANADA

EFEXOR — TAB 75 MG TABLET 75MG WYETH-AYERSTCANADA INC.

CANADA

EFEXOR TAB 37.5 MG TABLETS 37.5MG WYETH-AYERSTCANADA INC.

CANADA

EFEXOR TAB 50MG TABLETS 50MG WYETH-AYERSTCANADA INC.

CANADA

EFEXOR TAB 75MG TABLETS 75MG WYETH-AYERSTCANADA INC

CANADA

EFEXOR TABLETS TABLET 37.5MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES— UK

UNITED KINGDOM

EFEXOR TABLETS TABLETS 75MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIESUK

UNITED KINGDOM

EFEXOR XL CAPSULE 75MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES— UK

UNITED KINGDOM

EFEXOR XL 150MG CAPSULES 150MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES

UNITED KINGDOM

EFEXOR XL CAPSULES CAPSULES 75MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES

IRELAND

EFEXOR XR CAPSULE SUSTAINED RELEASECAPSULE

75MG WYETH-AYERSTCANADA INC.

CANADA

EFEXOR XR CAPSULES SUSTAINED RELEASECAPSULE

150MG WYETH-AYERSTCANADA INC.

CANADA

EL544 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

EFEXORXL 150 MG MODIFIEDRELEASECAPSULE

CAPSULE 150MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES-UK

UNITED KINGDOM

EFFACNE 5 TOPICAL GEL 5G/100G LABORATOIRES LAROCHE-POSAY

FRANCE

EFFERALGAN PAEDIATRIC 3% ORAL SOLUTION 3% W / V LABORATOIRES UPSA FRANCE

EFFERALGAN VITAMIN C SCORED EFF. TABLETS N/A LABORATOIRES UPSA FRANCE

EFFERCITRATE TABLETS EFFERVESCENT TABLET N/A TYPHARM LIMITED UNITED KINGDOM

EFFEXOR TAB 37.5MG TABLET 37.5MG WERTH-AYERSTCANADA INC.

CANADA

EFFICO TONIC ORAL SOLUTION 0.18MG/5ML PHARMAX LIMITED UNITED KINGDOM

EFFORTIL DROPS SOLUTION 0.75G/100G BOEHRINGER INGELHEIMPHARMA KG

GERMANY

EFLORAN SOLUTION FORINFUSION

500MG/100ML KRKA, D.D., NOVOMESTO

SLOVENIA

EFUDIX CREAM 5% W/W ICN PHARMACEUTICALSLTD

UNITED KINGDOM

EGOCORT CREAM 10MG/G EGO PHARMACEUTICALS AUSTRALIA

ELBAT TABLET 250MG GENEPHARM S.A. GREECE

ELDOPAQUE FORTE CREAM 4 % ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

ELDOPAQUE FORTE 4% CREAM 4% W/W ICN PHARMACEUTICALS,INC.

UNITED STATES OFAMERICA

ELDOQUIN FORTE 4% CREAM ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

ELDOQUIN FORTE 4% CREAM 4% W/W ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

ELECTROLADE BANANA POWDER FOR ORALSOLUTION

N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

ELECTROLADE BANANA POWDER FOR ORALSOLUTION

N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

ELECTROLADE BLACKCURRANT POWDER FOR ORALSOLUTION

N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

ELECTROLADE BLACKCURRANT POWDER FOR ORALSOLUTION

N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

ELECTROLADE LEMON AND LIME POWDER FOR ORALSOLUTION

N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

ELECTROLADE MELON POWDER FOR ORALSOLUTION

N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

ELECTROLADE ORANGE POWDER FOR ORALSOLUTION

N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 545

Trade Name Dosage Form Dose MA Holder Country

ELECTROLADE ORANGE POWDER FOR ORALSOLUTION

N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

ELIDIL CREAM 1% NOVARTIS HEALTHCAREA/S

DENMARK

ELINAP TABLETS 100MG KLEVA LIMITED GREECE

ELITAN TABLET 10MG MEDOCHEMIE LTD CYPRUS

ELITAN 10MG SUPPOSITORY 10MG MEDOCHEMIE LTD CYPRUS

ELITAN 10MG/2ML LIQUID FOR INJECTION 10MG/2ML MEDOCHEMIE LTD CYPRUS

ELITAN 20MG SUPPOSITORY 20MG MEDOCHEMIE LTD CYPRUS

ELMETIN 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS

ELMETIN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

ELOCOM CREAM 0.1% W/W S-P CANADA CANADA

ELOCOM OINTMENT 0.1% W/W S-P CANADA CANADA

ELOCOM LOTION 1MG/G S-P CANADA CANADA

ELOQUINE 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

ELOXATIN 5MG/ML POWDER FORSOL FOR INF.

POWDER FOR SOL. FORINF.

5MG/ML SANOFI WINTHROPLIMITED

FRANCE

ELPEGON ORAL SUSPENSION 5MG/5ML ELPEN PHARM CO. INC. GREECE

ELPEGON TABLET 5MG ELPEN S.A. GREECE

ELPEGON TABLET 10MG ELPEN S.A. GREECE

ELTROXIN TABLETS 100MCG GOLSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

ELTROXIN TABLET 50MCG GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

ELTROXIN TABLETS 100MCG TABLET 100MCG GOLDSHIELDPHARMACEUTICALS LTD

UNITED KINGDOM

ELTROXIN TABLETS 50 MCG TABLET 50MCG GOLDSHIELDPHARMACEUTICALS LTD

UNITED KINGDOM

ELUMATIC III SOLUTION FORINJECTION

NA CIS BIO INTERNATIONAL FRANCE

EMADINE EYE DROPS, SOLUTION 0.5MG/ML ALCON LABORATORIES(UK) LTD

UNITED KINGDOM

EMESET SOLUTION FORINJECTION

2MG/4ML CIPLA LTD INDIA

EMESET INJECTION SOLUTION FORINJECTION

2ML CIPLA INDIA

EMESET-4 TABLETS 4MG CIPLA LTD INDIA

EMLA CREAM N/A ASTRA LAKEMEDEL AB SWEDEN

EMOCLOT D.I. SOLUTION FORINJECTION

1000I.U. KEDRION S.P.A. ITALY

EL546 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

EMOCLOT D.I. SOLUTION FORINJECTION

1000I.U. KEDRION S.P.A. ITALY

EMTHEXATE TABLETS 2.5MG PHARMACHEMIE B.V. NETHERLANDS

EMULSIFYING OINTMENT BP OINTMENT N/A ADAMS HEALTHCARELIMITED

UNITED KINGDOM

E-MYCIN POWDER FOR ORALLIQUID

200MG/5ML ALPHAPHARM PTYLIMITED

AUSTRALIA

E-MYCIN TABLET 400MG ALPHAPHARM PTYLIMITED

AUSTRALIA

ENACE TABLETS 10MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

ENACE TABLETS 5MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

ENALAPRIL MALEATE TABLET 20MG RANBAXYLABORATORIES LTD.

INDIA

ENALAPRIL MALEATE TABLETS 20MG VYSALIPHARMACEUTICALSLIMITED

INDIA

ENALAPRIL MALEATE TABLETS 20MG NORTON HEALTHCARELTD

UNITED KINGDOM

ENALAPRIL MALEATE TABLETS5MG

TABLET 5MG SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

ENANTONE POWDER FOR IM/SCINJECT.

3.75MG TAKEDA ITALIAFARMACEUTICI S.P.A.

ITALY

ENANTONE POWDER FOR IM/SCINJECT.

11.25MG TAKEDA ITALIAFARMACEUTICI S.P.A.

ITALY

ENAP TABLET 5MG KRKA, D.D., NOVOMESTO

SLOVENIA

ENATEC 10 TABLETS 10MG MEPHA PHARMA AG SWITZERLAND

ENATEC 20 TABELTS 20MG MEPHA PHARMA AG SWITZERLAND

ENATEC 5 TABLETS 5MG MEPHA PHARMA AG SWITZERLAND

ENBREL SOLUTION FORINJECTION

25MG WYETH EUROPA LTD UNITED KINGDOM

ENBREL POWDER FOR INJECTION 25MG IMMUNEXCORPORATION

UNITED STATES OFAMERICA

ENDEKAY FLOUTABS 2-4 YEARS TABLET 1.1MG MANX PHARMA LIMITED UNITED KINGDOM

ENDEKAY FLUORINSE DENTAL SOLUTION 2% W/V MANX PHARMA LIMITED UNITED KINGDOM

ENDEKAY FLUOTABS 4+ YEARS TABLET 2.2MG MANX PHARMA LIMITED UNITED KINGDOM

ENDOBULIN S/D 500MG POWDER FOR INJECTION NS BAXTER AG AUSTRIA

ENDOXAN SUGAR-COATEDTABLETS

50MG ASTA MEDICA GERMANY

ENDOXAN POWDER FOR INJECTION 200MG ASTA MEDICA GERMANY

ENDOXAN POWDER FOR INJECTION 500MG ASTA MEDICA GERMANY

ENDOXAN POWDER FOR INJECTION 1G ASTA MEDICA GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 547

Trade Name Dosage Form Dose MA Holder Country

ENELFA 125 SUPPOSITORIES 125MG DOLORGEIT GMBH & COKG

GERMANY

ENELFA 125MG SUPPOSITORY 125MG DOLORGIET GMBH & CO.KG

GERMANY

ENELFA 250 SUPPOSITORIES SUPPOSITORIES 250MG DOLORGEIT GMBH & COKG

GERMANY

ENELFA 250MG SUPPOSITORY 250MG DOLORGIET GMBH & CO,KG

GERMANY

ENELFA 500 SUPPOSITORY 500MG DOLORGIET GMBH & CO.KG

GERMANY

ENELFA SYRUP SOLUTION 2G/100ML DOLORGIET GMBH & CO.KG

GERMANY

ENELFA SYRUP SOLUTION SYRUP 100ML DOLORGEIT GMBH & COKG

GERMANY

ENGERIX B SUSPENSION FORINJECTION

10MCG/0.5ML SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

ENGERIX B SUSPENSION FORINJECTION

20MCG/ML SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

ENGERIX B SUSPENSION FORINJECTION

NA SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

ENGERIX B JUNIOR SUSPENSION FORINJECTION

NA GLAXOSMITHKLINEBIOLOGICALS SA

BELGIUM

ENO POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

ENPRIN GASTRO-RESISTANTTABLET

75MG HEALTHY IDEAS LIMITED UNITED KINGDOM

ENPRIN GASTRO-RESISTANTTABLET

75MG HEALTHY IDEAS LIMITED UNITED KINGDOM

ENTOCORT SOLUBLET AND SOL FORENEMA

0.02MG/ML TIKA LAKEMEDEL AB SWEDEN

ENTOCORT PROLONGED RELEASECAPSULE

3MG TIKA LAKEMEDEL AB SWEDEN

ENTOX-P TABLET 500MG CYNAMID (PAKISTAN)LIMITED

PAKISTAN

ENTROCALM LOPERAMIDE CAPSULES 2MG GALPHARMHEALTHCARE LIMITED

UNITED KINGDOM

ENTROCALM REPLACE GRANULES FOR ORALSOLN.

N/A HEALTHY IDEAS LIMITED UNITED KINGDOM

ENTROCALM REPLACE GRANULES FOR ORALSOL.

N/A HEALTHY IDEAS LIMITED UNITED KINGDOM

ENZIFLUR TABLET 5MG BROS LTD GREECE

EOLARIX POWDER FOR INJECTION N/A SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

EPADOREN SOLUTION FORINECTION

N/A DEMO ABEE SA GREECE

EPADOREN COATED TABLET 150MG DEMO ABEE GREECE

EL548 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

EPADOREN SYRUP 75MG/5ML DEMO ABEE GREECE

EPANUTIN CAPSULE 100MG PARKE-DAVIS GMBH GERMANY

EPANUTIN CAPSULES 25MG CAPSULE 25MG WARNER LAMBERT (UK)LIMITED

UNITED KINGDOM

EPANUTIN CAPSULES 300MG CAPSULE 300MG WARNER LAMBERT (UK)LIMITED

UNITED KINGDOM

EPANUTIN CAPSULES 50MG CAPSULE 50MG WARNER LAMBERT (UK)LIMITED

UNITED KINGDOM

EPANUTIN PARENTERAL SOLUTION FORINJECTION

250MG/5ML PARKE-DAVIS GMBH GERMANY

EPANUTIN SUSPENSION ORAL SUSPENSION 30MG/5ML WARNER LAMBERT (UK)LIMITED

UNITED KINGDOM

EPAXAL BERNA SOLUTION FORINJECTION

N/A ISTITUTOSIEROTERAPICO BERNAS.R.L.

ITALY

EPHEDRINE AGUETTANT 3% INJECTABLE SOLUTION 3% W/V LABORATOIREAGUETTANT

FRANCE

EPHEDRINE HYDROCHLORIDE BP30MG

TABLET 30MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

EPHEDRINE HYDROCHLORIDE BP30MG/ML

SOLUTION FORINJECTION

3%W/V MACARTHYS LABORAT.LTD. T/A MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

EPHEDRINE HYDROCHLORIDETABLETS BP 15MG

TABLETS 15MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

EPHEDRINE HYDROCHLORIDETABLETS BP 30MG

TABLETS 30MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

EPHEDRINE SULFATE INJECTIONUSP

SOLUTION FORINJECTION

50MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

EPIFOAM TOPICAL AEROSOL N/A SCHWART PHARMA INC UNITED STATES OFAMERICA

EPILAT SOFT GELATIN CAPSULES 10MG EGYPTIANINTERNATIONALPHARMACEUTICALINDUSTRIES CO (EIPICO)

EGYPT

EPILIM 100MG CRUSHABLE TABLET 100MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

EPILIM 200MG ENTERIC COATEDTABLET

200MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

EPILIM 500MG ENTERIC COATEDTABLET

500MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

EPILIM CHRONO 300MG MODIFIED RELEASETABLET

300MG SANOFI SYNTHELABOLIMITED

UNITED KINGDOM

EPILIM INTRAVENOUS POWDERFOR INJECTION

POWDER FOR INJECTION 400MG/VIAL SANOFI WINTHROPLIMITED

UNITED KINGDOM

EPILIM/SODIUM VALPROATE200MG/5ML LIQUID

ORAL SOLUTION 200MG/5ML SANOFI WINTHROPLIMITED

UNITED KINGDOM

EPINEPHRINE (ADRENALINE) INJMINIJET

AQUEOUS SOLUTION 1MG/10ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 549

Trade Name Dosage Form Dose MA Holder Country

EPINEPHRINE (ADRENALINE) INJ.MINIJET

SOLUTION FORINJECTION

1:10,000 INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

EPIRAZOLE CAPSULE 20MG EGYPTIANINTERNATIONALPHARMACEUTICALINDUSTRIES CO (EIPICO)

EGYPT

EPIVIR ORAL SOLUTION 10MG/ML GLAXO GROUP LTD. UNITED KINGDOM

EPIVIR COATED TABLETS 150MG GLAXO GROUP LTD. UNITED KINGDOM

EPOKELAN SCALP LOTION 2% W/W MEDOCHEMIE LTD CYPRUS

EPPY EYE DROPS 1% W/V CHAUVINPHARMACEUTICALSLIMITED

UNITED KINGDOM

EPREX INJECTION SOLUTION SEE REMARKS JANSSEN-CILAG AG SWITZERLAND

EPREX 10000U/ML INJECTIONSOLUTION

PREFILLED SYRINGE 10000 IU/ML JANSSEN-CILAG AG SWITZERLAND

EPREX 10000U/ML INJECTIONSOLUTION

VIAL 10000 IU/ML JANSSEN-CILAG AG SWITZERLAND

EPREX 1000U/0.5ML INJECTIONSOLUTION

PREFILLED SYRINGE 1000 IU/0.5ML JANSSEN-CILAG AG SWITZERLAND

EPREX 2000U/0.5ML INJECTIONSOLUTION

PREFILLED SYRINGE 2000 IU/0.5ML JANSSEN-CILAG AG SWITZERLAND

EPREX 2000U/ML INJECTIONSOLUTION

VIAL 2000 IU/ML JANSSEN-CILAG AG SWITZERLAND

EPREX 3000U/0.3ML INJECTIONSOLUTION

PREFILLED SYRINGE 3000 IU/0.3ML JANSSEN-CILAG AG SWITZERLAND

EPREX 4000U/0.4ML INJECTIONSOLUTION

PREFILLED SYRINGE 4000 IU/0.4ML JANSSEN-CILAG AG SWITZERLAND

EPREX 4000U/ML INJECTIONSOLUTION

VIAL 4000 IU/ML JANSSEN-CILAG AG SWITZERLAND

EPSOM SALTS BP ORAL POWDER 100%W/W LCM LTD UNITED KINGDOM

ERCEFURYL 200MG CAPSULE 200MG LABORATOIRESSYNTHELABO

FRANCE

ERCEFURYL 4% ORAL SUSPENSION 4% W/W LABORATOIRESSYNTHELABO

FRANCE

ERIOS SUSPENSION 200MG/5ML MEPHA PHARMA AG SWITZERLAND

ERIOS-250 LACTAB 250MG MEPHA PHARMA AG SWITZERLAND

ERIOS-500 LACTAB 500MG MEPHA PHARMA AG SWITZERLAND

ERITROPIU TABLETS 80MG FARMA UNO SRL ITALY

ERMYCED 125 ORAL SUSPENSION 125MG/5ML REMEDICA LTD CYPRUS

ERVEVAX POWDER FOR INJECTION >=10(3) TCID50 SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

ERYACNE 4 GEL 4% W/W GALDERMA (UK) LIMITED UNITED KINGDOM

ERYC CAPSULE 250MG FAULDINGPHARMACEUTICALS

AUSTRALIA

EL550 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ERYCYTOL DEPOT SOLUTION FORINJECTION

N/A LANNACHER HEILMITTELGMBH.

AUSTRIA

ERYHEXAL 500 FILM-COATED TABLET 500MG HEXAL AG GERMANY

ERYHEXAL FORTE SAFT GRANULES FORSUSPENSION

400MG /5ML HEXAL AG GERMANY

ERYHEXAL SAFT GRANULES FORSUSPENSION

235MG/5ML HEXAL AG GERMANY

ERYTHRO 125 GRANULES GRANULES FORSUSPENSION

125MG/5ML CAMDEN INDUSTRIES (M)SDN. BHD

MALAYSIA

ERYTHRO 125 GRANULES GRANULES F/ORAL SUSP. 125MG/5ML CAMDEN INDUSTRIES (M)SDN. BHD.

MALAYSIA

ERYTHRO-250 TABLET TABLET 250MG CAMDEN INDUSTRIES (M)SDN.BHD

MALAYSIA

ERYTHROCIN LYOPHILIZED POWDER F/INJ.

1G ABBOTT FRANCE FRANCE

ERYTHROCIN 250MG TABLETS COATED TABLETS 250MG ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

ERYTHROCIN LACTOBIONATE 1GVIAL

POWDER FOR IVINFUSION

1G ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

ERYTHROMYCIN(ERYTHRO-TEVA) TABLETS

TABLET 250MG TEVA PHARMACEUTICALINDUSTRIES LTD

ISRAEL

ERYTHROMYCIN INJECTION VIAL POWDER FOR INJECTION 1G/VIAL F.H. FAULDING & CO.LTD. (T/A DAVID BULLLABS)

UNITED KINGDOM

ERYTHROMYCIN STEARATE TABLET 250MG PHARMAMED LTD. MALTA

ERYTHROMYCIN STEARATE TABSESTYMICIN

FILM COATED TABLET 250MG TABLETS (INDIA) LIMITED INDIA

ERYTHROPED PI 125MG/5ML GRANULES FOR ORALSOL.

125MG/5ML ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

ESELAN ENTERIC CAPSULE 20MG ANFARM HELLAS S.A. GREECE

ESKORNADE SPANSULE CAPSULES MODIFIED RELEASECAPSULE

N/A SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

ESKORNADE SYRUP ORAL SOLUTION N/A SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

ESMERON 100MG=10ML SOLUTION FORINJECTION

10MG/ML ORGANON TEKNIKA B.V.(PART OF AKZO NOBEL)

NETHERLANDS

ESMERON 250MG=25ML SOLUTION FORINJECTION

10MG/ML ORGANON TEKNIKA B.V.(PART OF AKZO NOBEL)

NETHERLANDS

ESMERON 50MG=5ML SOLUTION FORINJECTION

10MG/ML ORGANON TEKNIKA B.V.(PART OF AKZO NOBEL)

NETHERLANDS

ESONIDE CREAM 0.025%W/W KLEVA LIMITED GREECE

ESONIDE METER DOSE NASALSPRAY

50MCG/DOSE KLEVA LIMITED GREECE

ESONIDE METER DOSE NASALSPRAY

100MCG/DOSE KLEVA LIMITED GREECE

ESTRACOMB TTS TRANSDERMAL PATCH N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 551

Trade Name Dosage Form Dose MA Holder Country

ESTRACOMB TTS TRANSDERMAL PATCHES N/A NOVARTISFARMACEUTICA S.A.SPAIN

SPAIN

ESTRADERM TTS TRANSDERMAL PATCH 2MG NOVARTIS PHARMAS.P.A.

ITALY

ESTRADERM TTS TRANSDERMAL PATCHES 4MG NOVARTIS PHARMAS.P.A.

ITALY

ESTRADERM TTS 100 TRANSDERMAL PATCH 8MG/20CM(2) NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ESTRADERM TTS 25 TRANSDERMAL PATCH 2MG/5CM(2) NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ESTRADERM TTS 50 TRANSDERMAL PATCH 4MG/10CM(2) NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ESTREVA TRANSDERMAL GEL 0.1G/100G LABORATOIRETHERMAX

FRANCE

ESTROFEM — 28 TABLETS TABLET 2MG NOVO NORDISK A/S DENMARK

ESTROFEM FORTE 28 -TABLETS TABLET 4MG NOVO NORDISK DENMARK

ETHAMBUTOL TABLETS 400MG PHARMAMED LTD. MALTA

ETHAMBUTOL HCL TABLET 400MG MACLEODS INDIA

ETHANOLAMINE OLEATE BP SOLUTION FORINJECTION

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

ETHOMID TABLET 250MG MACLEODS INDIA

ETHRANE SOLN F/INHALATION 99G/100ML ABBOTT S.P.A ITALY

ETHYL CHLORIDE «DR. HENNING» SPRAY LIQUID N/A DR. GEORG FRIEDRICHHENNING

GERMANY

ETILTOX TABLETS 200MG A.F.O.M. MEDICAL SPA ITALY

ETINILESTRADIOLO AMSA TABLETS 0.01MG A.M.S.A. S.R.L. ITALY

ETOMIDATE LIPURO EMULSION FOR IVINJECTION

20MG/10ML B.BRAUN MELSUNGENAG

GERMANY

ETOPOS INJECTABLE SOLUTION SEE REMARKS LEMERY S.A. DE C.V. MEXICO

ETOPOSIDE INJECTION VIAL SOLUTION FORINJECTION

100MG/5ML PHARMACIA (PERTH) PTYLIMITED

AUSTRALIA

ETOPOSIDE MERCK 20MG/ML SOLUTION FORPERFUSION

20MG/ML MERCK GENERIQUES FRANCE

ETOPOSIDE PHARMACIA CONCENTRATE FORSOLUTION FORINFUSION

20MG/ML PHARMACIA OY FINLAND

ETOPOSIDE PIERRE FABRE100MG/5ML

INJ. SOL. FOR I.V. INF. 100MG/5ML PIERRE FABREMEDICAMENT

FRANCE

ETOPUL SOLUTION FORINJECTION

100MG KOREA UNITED PHARM.INC.

KOREA REPUBLIC

ETOSID CAPSULES 50MG CIPLA LTD INDIA

ETOSID CAPSULE 50 MG CIPLA LTD INDIA

EUCARBON TABLETS N/A F.TRENKA CHEM-PHARMFABRIK G.M.B.H

AUSTRIA

EL552 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

EUCYCLINE SYRUP 1MG/5ML DEMO ABEE GREECE

EUGLUCON TABLET 5MG ROCHE PAKISTAN

EUGLUCON TABLET 5MG BOEHRINGER-INGELHEIM PAKISTAN

EUGLUCON 5MG TABLET 5MG HOFFMANN-LA ROCHEAG

GERMANY

EULEXIN TABLETS TABLETS 250MG SCHERING-PLOUGHNV/SA

BELGIUM

EUMOVATE CREAM CREAM 0.05% W/W GLAXO WELLCOME UKLTD

UNITED KINGDOM

EUMOVATE CREAM CREAM 0.05%W/W GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

EUMOVATE ECZEMA ANDDERMATITIS CREAM

CREAM 0.005% GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

EUMOVATE OINTMENT OINTMENT 0.05% W/W GLAXO WELLCOME UKLTD

UNITED KINGDOM

EUPEN CAPSULE 500MG J.URIACH & CIA. S.A. SPAIN

EUPEN BRONQUIAL CAPSULE N/A J.URIACH & CIA. S.A. SPAIN

EUPEN DROPS ORAL SUSPENSION 100MG/ML J.URIACH & CIA. S.A. SPAIN

EUPEN SACHETS 250MG GRANULES 250MG J.URIACH & CIA. S.A. SPAIN

EURAX CREAM 100MG/G NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

EURAX LOTION 100MG/G NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

EUROCEFIX CAPSULES 500MG FARMA UNO SRL ITALY

EUROCEFIX ORAL SUSPENSION 250MG/5ML FARMA UNO SRL ITALY

EVISTA FILM COATED TABLETS 60MG ELI LILLY NEDERLANDB.V.

NETHERLANDS

EVOREL 100 TRANSDERMAL PATCH 100MCG/24 JANSSEN-CILAG LIMITED SWITZERLAND

EVOREL 50 TRANSDERMAL PATCH 50MCG/24 JANSSEN-CILAG LIMITED SWITZERLAND

EVOREL 75 TRANSDERMAL PATCH 75MCG/24 JANSSEN-CILAG LIMITED SWITZERLAND

EXACYL 0.5MG/5ML SOLUTION FORINJECTION

0.5MG/5ML SANOFI WINTHROP FRANCE

EXELON ORAL SOLUTION 2MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EXELON ORAL SOLUTION 2MG/ML NOVARTISEUROPHARMA LIMITED

UNITED KINGDOM

EXELON HARD GELATIN CAPSULE NA NOVARTIS PHARMASCHWIEZ AG

SWITZERLAND

EXELON HARD CAPSULES 1.5MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

EXELON HARD CAPSULES 3MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

EXELON HARD CAPSULES 4.5MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 553

Trade Name Dosage Form Dose MA Holder Country

EXELON HARD CAPSULES 6MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

EXELON 0.5MG CAPSULES 0.5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EXELON 1.5MG CAPSULES 1.5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EXELON 1MG CAPSULES 1MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EXELON 3MG CAPSULES 3MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EXELON 4.5MG CAPSULES 4.5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EXELON 6MG CAPSULES 6MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EXOLIT 4MG/5ML ELIXIR 4MG/5ML MEDOCHEMIE LTD CYPRUS

EXOLIT 8MG TABLET 8MG MEDOCHEMIE LTD CYPRUS

EXOSURF NEONATAL POWDER FOR INJECTION 108MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

EXPECTORAN SYRUP N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

EXPECTORAN WITH CODEIN SYRUP N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

EXPULIN CHILDREN'S COUGHLINCTUS

ORAL SOLUTION (SUGARFREE

N/A MONMOUTHPHARMACEUTICALSLIMITED

UNITED KINGDOM

EXPULIN COUGH LINCTUS SUGARFREE

ORAL SOLUTION N/A MONMOUTHPHARMACEUTICALS LTD.

UNITED KINGDOM

EXPULIN DECONGESTANT-BABIES AND CHILDREN

ORAL SOLUTION N/A MONMOUTHPHARMACEUTICALS LTD.

UNITED KINGDOM

EXPUTEX ORAL LIQUID 250MG/5ML MONMOUTHPHARMACEUTICALS LTD.

UNITED KINGDOM

EXTRA STRENGTH COLD MEDNIGHTTIME RELIEF

TABLET N/A STANLEYPHARMACEUTICALS LTD

CANADA

EXTRA STRENGTH COLD MEDI.DAYTIME RELIEF

TABLET N/A STANLEYPHARMACEUTICALS LTD

CANADA

EXTRAFER ORAL SOLUTION 113.5MG/10ML SO.SE.PHARM S.R.L. SOC.DI SERVIZ. PER L'INDUS.FARM. ED AFF

ITALY

EXTRANEAL (ICODEXTRIN 7.5%) SOL F/INTRAPERITONEALADM

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

EZIPOL ENTERIC COATEDCAPSULES

20MG KLEVA LIMITED GREECE

FADOL POWDER FOR INJ.SOLUTION

100MG/250MG/500 LEMERY S.A. DE C.V. MEXICO

FALICARD I.V. INJECTION SOLUTION 5MG/2ML ARZNEIMITTELWERKDRESDEN GMBH

GERMANY

FAM-LAX PHENOLPHTHALEIN TABLETS N/A TORBET LABORATORIESLIMITED

UNITED KINGDOM

EL554 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FAM-LAX SENNA LAXATIVE TABLETS N/A MODERN HEALTHPRODUCTS LIMITED

UNITED KINGDOM

FAMO FILM COATED TABLETS 40MG CTS CHEMICALINDUSTRIES LTD.

ISRAEL

FAMO 40 FILM COATED TABLET 40MG CTS CHEMICALINDUSTRIES LTD

ISRAEL

FAMODAR TABLET 40MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

FAMVIR TABLETS 125MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

FAMVIR TABLETS 250MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

FAMVIR TABLETS 125MG NOVARTISFARMACEUTICA S.A

SPAIN

FAMVIR TABLETS 250MG NOVARTISFARMACEUTICA S.A

SPAIN

FAMVIR 125MG TABLET COATED TABLET 125MG SMITHKLINE BEECHAMPLC

UNITED KINGDOM

FAMVIR TABLETS 125 MG FILM-COATED TABLETS 125 MG NOVARTISPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

FAMVIR TABLETS 250 MG FILM-COATED TABLETS 250 MG NOVARTISPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

FAMVIR TABLETS 250MG COATED TABLET 250MG SMITHKLINE BEECHAMPLC

UNITED KINGDOM

FARMORUBICINA POWDER FOR INJECTION 10MG/VIAL PHARMACIA & UPJOHNS.P.A.

ITALY

FARMORUBICINA POWDER FOR INJECTION 50MG/VIAL PHARMACIA & UPJOHNS.P.A.

ITALY

FARMORUBICINA POWDER AND SOLVENTF/SOLN F/INJ.

N/A PHARMACIA ITALIA S.P.A ITALY

FARMORUBICINA SOLUTION FOR IVINFUSION

10MG/5ML PHARMACIA ITALIA S.P.A ITALY

FARMORUBICINA SOLUTION FOR IVINFUSION

50MG/25ML PHARMACIA ITALIA S.P.A ITALY

FARMORUBICINA POWDER FOR SOLUTIONFOR INJECTION

50MG PHARMACIA ITALIA SPA ITALY

FARVIRAN VAGINAL DOUCHE,SOLUTION

3.3G/100ML FARMIGEA SPA ITALY

FASIGYN TABLET 500MG PFIZER LIMITED UNITED KINGDOM

FAST POWDER N/A MEDOCHEMIE LTD CYPRUS

FASTUM GEL 2.5G/100G A.MENARINI INDUSTRIEFARMACEUTICHERIUNITE S.R.L.

ITALY

FASTUM, TUBO CON DISPENSER GEL 2.5% A. MENARINI INDUSTRIEFARMACEUTICHERIUNITE S.R.L.

ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 555

Trade Name Dosage Form Dose MA Holder Country

FAVE DI FUCA TABLETS N/A ROCHE S.P.A. ITALY

FAVERIN 100 TABLET 100MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

FAVERIN 50 TABLET 50MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

FEFOL SPANSULE SUSTAINED RELEASECAPSULE

N/A SMITH KLINE &BEECHAM

PAKISTAN

FEFOL SPANSULE CAPSULE MODIFIED RELEASECAPSULE

N/A SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

FEFOL Z SPANSULE CAPSULES MODIFIED RELEASECAPSULE

N/A SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

FEIBA S-TIM 4 FAKTOR VIIIINHIBITOR

DRY SUBS IN VIAL +SOLV.

500U/20ML BAXTER AG AUSTRIA

FELDENE CAPSULE 20MG PFIZER LIMITED UNITED KINGDOM

FELDENE CAPSULES 10MG PFIZER LIMITED UNITED KINGDOM

FELDENE TOPICAL GEL N/A PFIZER LIMITED UNITED KINGDOM

FELDENE TABLETS 20MG PFIZER LIMITED UNITED KINGDOM

FELDENE TABLETS 20MG PFIZER LIMITED UNITED KINGDOM

FELDENE CAPSULE 20MG PFIZER PAKISTAN

FELDENE GEL 5MG/G PFIZER PAKISTAN

FELDENE 0.5% GEL GEL N/A PFIZER SA BELGIUM

FELDENE 20MG DISPERSIBLE TABLET 20MG PFIZER PAKISTAN

FEMARA TABLETS 2.5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

FEMARA COATED TABLET 2.5 MG NOVARTISPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

FEMINAX TABLET SEE REMARKS ROCHE PRODUCTSLIMITED

UNITED KINGDOM

FEMOSTON 1/10 TABLET N/A SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

FEMOSTON 2/10 TABLET N/A SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

FEMOSTON 2/20 TABLET N/A SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

FEMOSTON CONTI TABLET N/A SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

FEMULEN TABLETS 0.5MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

FEMULEN TABLETS 0.5MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

FENADOL SOLUTION FORINJECTION

75MG/3ML PROGE FARM S.R.L. ITALY

FENADOL SUPPOSITORY 100MG PROGE FARM S.R.L. ITALY

EL556 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FENADOL «RETARD» COMPRESSE 100MG PROGE FARM S.R.L ITALY

FENADOL 5 FIALE 75MG/3ML FIALE 75MG / 3ML PFOGE FARM S.R.L ITALY

FENADOL RETARD SLOW RELEASE TABLET 100MG PROGE FARM S.R.L. ITALY

FENAMIDE TABLETS 50MG FARMIGEA SPA ITALY

FENAMON 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS

FENAMON 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

FENAMON S.R. 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS

FENAZIL CREAM 2% LABORATORIO CHIMICOFARMACEUTICO A.SELLA S.R.L

ITALY

FENBID GEL 5% W/W GOLDSHIELD GROUP PLS UNITED KINGDOM

FENBID SPANSULE MODIFIED RELEASECAPSULE

300MG GOLDSHIELD GROUP PLC UNITED KINGDOM

FENBID SPANSULE CAPSULES MODIFIED RELEASECAPSULE

300MG MENLEY & JAMESLIMITED

UNITED KINGDOM

FENBUFEN CAPSULES 300MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

FENBUFEN TABLETS 300MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

FENBUFEN TABLETS 450MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

FENBUFEN 450MG TABLETS COATED TABLET 450MG SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

FENBUFEN TABLETS 300MG TABLET 300MG SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

FENESTIL PROLONGED RELEASECAPSULE

4MG NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

FENISTIL GEL 1MG/G NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

FENISTIL DROPS 1MG/ML NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

FENISTIL SYRUP 0.5MG/5ML NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

FENNINGS CHILDREN'S COOLINGPOWDER

ORAL POWDER 50MG ANGLIAN PHARMA PLC UNITED KINGDOM

FENTANYL CITRATE SOLUTION FORINJECTION

0.05MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

FENTANYL CITRATE SOLUTION FORINJECTION

100MG//PER 2ML ANITGENPHARMACEUTICALS LTD

IRELAND

FENTANYL CITRATE SOLUTION FORINJECTION

500MC/10ML ANTIGENPHARMACEUTICALS

IRELAND

FENTANYL CITRATE INJECTION SOLUTION FORINJECTIONS

100MCG/2ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 557

Trade Name Dosage Form Dose MA Holder Country

FENTANYL CITRATE INJECTION SOLUTION FORINJECTION

500MCG/10ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

FENTANYL-JANSSEN 0.05MG/ML10ML AMP

AMPOULE 0.05MG/ML JANSSEN-CILAG N.V. BELGIUM

FENTANYL-JANSSEN 0.05MG/ML2ML AMP

AMPOULE 0.05MG/ML JANSSEN-CILAG N.V BELGIUM

FENULIN TABLETS TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

FERR. PHOS. 6X NEW ERABIOCHEMIC NO.4

TISSUE SALTS TABLETSNO.4

NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

FERROGRAD MODIFIED RELEASETABLETS

325MG ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

FERROGRAD FOLIC MODIFIED RELEASETABLETS

N/A ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

FERROGRADUMET MODIFIED RELEASETABLETS

325MG ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

FERROGYN 80MG EFFERVESCENT TABLETS 80MG SOCIETA' DI SERVIZIOPER L'INDUSTRIAFARMACEUTICA

ITALY

FERRONAL TABLETS 300MG CTS CHEMICALINDUSTRIES

ISRAEL

FERRONAL TABLETS TABLET 300MG CTS CHEMICALINDUSTRIES LTD

ISRAEL

FERROUS FUMARATE 200 TABLETS 200MG REMEDICA LTD CYPRUS

FERROUS GLUCONATE 30MG TABLET 300MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

FERROUS SULPHATE TABLETS BP200MG

COATED TABLET 200MG RANBAXY IRELANDLIMITED

IRELAND

FIBERCON CAPLETS 500MG LEDERLEPHARMACEUTICALDIVISION OF AMERICACYANAMID CO.

UNITED STATES OFAMERICA

FIBER-CON CAPLETS CAPLETS NS WYETH CONSUMERHEALTHCARE

UNITED STATES OFAMERICA

FIBRA 3 PWD FOR ORALRECONSTITUTI

N/A BIODES, S.L. SPAIN

FIERY JACK CREAM CREAM N/A RUDGE ROBERTSLIMITED

UNITED KINGDOM

FILAIR 100 INHALER AEROSOL 100MCG/ACTUAT. 3M HEALTH CARELIMITED

UNITED KINGDOM

FILAIR 50 INHALER AEROSOL 50MCG/ACTUAT. 3M HEALTH CARELIMITED

UNITED KINGDOM

FILAIR FORTE INHALER AEROSOL 250MCG/ACTUAT. 3M HEALTH CARELIMITED

UNITED KINGDOM

FILICINE TABLET 5MG ADELCO-CHROMATOURGIAATHINONE.COLOCOTRONIS BROSS.A.

GREECE

EL558 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FINCAR TABLETS 5MG CIPLA LTD INDIA

FLAGENTYL 500MG TABLETS 500MG SPECIA LABORATORIES FRANCE

FLAGYL TABLET 400MG RHONE POULENC RORER PAKISTAN

FLAGYL TABLET 200MG RHONE POULENC RORER PAKISTAN

FLAGYL FILM COATED TABLET 200MG RHONE-POULENC-RORER PAKISTAN

FLAGYL FILM COATED TABLET 400MG RHONE-POULENC-RORER PAKISTAN

FLAGYL SUPPOSITORIES 500MG HAWGREEN LIMITED UNITED KINGDOM

FLAGYL INJECTION 0.5% W/V(100ML)

SOLUTION FORINJECTION

0.5% W/V MAY & BAKER LIMITED UNITED KINGDOM

FLAGYL S SUSPENSION N/A HAWGREENLIMITED(IRELAND)

UNITED KINGDOM

FLAGYL S SUSPENSION ORAL SUSPENSION 200MG/5ML HAWGREEN LIMITED IRELAND

FLAGYL TABLETS 200MG FILM COATED TABLET 200MG HAWGREEN LIMITED IRELAND

FLAGYL TABLETS 400MG TABLET 400MG HAWGREEN LIMITED IRELAND

FLAMAZINE 1% CREAM 1%W/W SMITH & NEPHEWPHARMACEUTICALSLIMITED

UNITED KINGDOM

FLAREX OPHTHALMIC SOLUTION 1MG/ML S.A. ALCON-COUVREURN.V.

BELGIUM

FLEET ADULT GLYCERINSUPPOSITORIES

SUPPOSITORIES 2G/SUPPOSITORY C.B. FLEET COMPANY UNITED STATES OFAMERICA

FLEET BABYLAX LIQ. GLYCERINSUPP.

LIQUID GLYCERIN SUPP. 2.3G/2.3ML C.B. FLEET COMPANY UNITED STATES OFAMERICA

FLEET CHILD GLYCERINSUPPOSITORIES

SUPPOSITORIES 1G/SUPPOSITORY C.B. FLEET COMPANY UNITED STATES OFAMERICA

FLEET PHOSPHO-SODA ORALSOLUTION

ORAL SOLUTION N/A E C DE WITT & CO LTD UNITED KINGDOM

FLEET READY TO USE ENEMA RECTAL SOLUTION N/A E C DE WITT & CO LTD UNITED KINGDOM

FLEET READY-TO-USE ENAMAF/CHILDREN

ENEMA N/A C.B. FLEET COMPANY UNITED STATES OFAMERICA

FLEET READY-TO-USE ENEMA ENEMA N/A C.B. FLEET COMPANY UNITED STATES OFAMERICA

FLEMOXIN DROPS POWDER FORSUSPENSION

100MG/ML YAMANOUCHI PHARMAB.V.

NETHERLANDS

FLEMOXIN SOLUTAB 250 TABLETS 250MG YAMANOUCHI PHARMAB.V.

NETHERLANDS

FLEMOXIN SOLUTAB 500 TABLETS 500MG YAMANOUCHI PHARMAB.V.

NETHERLANDS

FLEMOXIN SUSPENSION POWDER FORSUSPENSION

125MG/5ML YAMANOUCHI PHARMAB.V.

NETHERLANDS

FLEMOXIN SUSPENSION FORTE POWDER FORSUSPENSION

250MG/5ML YAMANOUCHI PHARMAB.V.

NETHERLANDS

FLETCHERS' ARACHIS OILRETENTION ENEMA

LIQUID EVACUATIONENEMA

130ML PHARMAX LIMITED UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 559

Trade Name Dosage Form Dose MA Holder Country

FLETCHERS' ENEMETTE LIQUID ENEMA SINGLEDOSE

N/A PHARMAX LIMITED UNITED KINGDOM

FLETCHERS' PHOSPHATE ENEMA LIQUID EVACUATIONENEMA

N/A PHARMAX LIMITED UNITED KINGDOM

FLEXIN-25 CONTINUS TABLETS MODIFIED RELEASETABLET

25MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

FLEXIN-50 CONTINUS TABLETS MODIFIED RELEASETABLET

50MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

FLEXIN-75 CONTINUS TABLETS MODIFIED RELEASETABLETS

75MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

FLIXONASE AQUEOUS NASAL SPRAY N/A ALLEN & HANDBURY'SLIMITED UK

IRELAND

FLIXONASE NASULE DROPS NASAL DROPS 400MCG GLAXO WELLCOMEAUSTRALIA LTD

AUSTRALIA

FLIXONASE AQUEOUS NASALSPRAY

NASAL SPRAY 0.05% W/W GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

FLIXONASE AQUEOUS NASALSPRAY

NASAL SPRAY 0.05%W/W GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

FLIXONASE AQUEOUS NASALSPRAY

NASAL SPRAYSUSPENSION

50MCG GLAXO WELLCOME S.A.-SPAIN

SPAIN

FLIXONASE NASULE DROPS NASAL DROPS 1MG/ML GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

FLIXOTIDE ACCUHALER INHALATION POWDER 50MCG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

FLIXOTIDE ACCUHALER INHALATION POWDER 100MCG/DOSE GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

FLIXOTIDE ACCUHALER 250MCG INHALATION POWDER 250MCG/BLISTER GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

FLIXOTIDE ACCUHALER 50MCG INHALATION POWDER 50MCG/BLISTER GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

FLIXOTIDE DISKUS INHALATION POWDER 100MCG GLAXO WELLCOME UKLTD T/A ALLEN &HANDBURYS

FRANCE

FLIXOTIDE DISKUS POWDER F/ORALINHALATION

50UG/DOSE LABORATOIRE GLAXOWELLCOME

FRANCE

FLIXOTIDE DISKUS POWDER F/ORALINHALATION

100UG/DOSE LABORATOIRE GLAXOWELLCOME

FRANCE

FLIXOTIDE DISKUS POWDER F/ORALINHALATION

250UG/DOSE LABORATOIRES GLAXOWELLCOME

FRANCE

FLIXOTIDE DISKUS INHALATION POWDER 250MCG GLAXO WELLCOME UKLIMITED

FRANCE

FLIXOTIDE DISKUS INHALTION POWDER 100MCG ALLEN AND HANBURY'SLTD -UK

UNITED KINGDOM

FLIXOTIDE DISKUS INHALTION POWDER 250 MCG ALLEN AND HANBURY'SLTD — UK

UNITED KINGDOM

FLIXOTIDE DISKUS 250MCG INHALATION POWDER 250MCG GLAXO WELLCOME UKLTD

UNITED KINGDOM

EL560 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FLIXOTIDE DISKUS 50MCG INHALATION POWDER 50MCG GLAXO WELLCOME UKLTD

UNITED KINGDOM

FLIXOTIDE DISKUS 50MCG INHALATION POWDER 50MCG GLAXO WELLCOME UKLIMITED

FRANCE

FLIXOTIDE EVOHALER AEROSOL 125UG/AC GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

FLIXOTIDE EVOHALER AEROSOL 250UG/AC GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

FLIXOTIDE EVOHALER AEROSOL 50MCG/AC GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

FLIXOTIDE EVOHALER PRESSURISEDINHALATIONSUSPENSION

250MCG/AC ALLEN & HANDBURY'SLIMITED

IRELAND

FLIXOTIDE EVOHALER 50MCG AEROSOL 50MCG/AC GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

FLIXOTIDE INHALER AEROSOL 125MCG/AC GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

FLIXOTIDE INHALER AEROSOL 250MCG/AC GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

FLIXOTIDE INHALER 125MICROGRAMS

AEROSOL 125MCG/AC GLAXO WELLCOME UKLTD

UNITED KINGDOM

FLIXOTIDE INHALER 250MICROGRAMS

AEROSOL 250MCG/AC GLAXO WELLCOME UKLTD

UNITED KINGDOM

FLIXOTIDE INHALER 50 AEROSOL 50MCG/AC GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

FLIXOTIDE INHALER 50MICROGRAMS

AEROSOL 50MCG/AC GLAXO WELLCOME UKLTD

UNITED KINGDOM

FLIXOTIDE INHALER 50MCG AEROSOL 50MCG/AC GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

FLIXOTIDE NEBULES SUSPENSION FORINHALATION

0.5MG/2ML GLAXO WELLCOMEAUSTRALIA LTD

AUSTRALIA

FLIXOTIDE NEBULES SUSPENSION FORINHALATION

2MG/2ML GLAXO WELLCOMEAUSTRALIA LTD

AUSTRALIA

FLIXOTIDE NEBULES INHALATIONSUSPENSION

0.5MG/2ML GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

FLIXOTIDE NEBULES INHALATIONSUSPENSION

2MG/2ML GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

FLIXOTIDE NEBULES 0.5MG/2ML INHALATIONSUSPENSION

0.5MG/2ML GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

FLIXOTIDE NEBULES 2MG/2ML INHALATIONSUSPENSION

2MG/2ML GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 561

Trade Name Dosage Form Dose MA Holder Country

FLODOL CAPSULES 20MG FARMA UNO SRL ITALY

FLODOL 1% GEL 1%W/W FARMA UNO SRL ITALY

FLOGOFENAC GEL 1%W/W ECOBI FARMACEUTICIS.A.S

ITALY

FLOGOFENAC SUPPOSITORIES 100MG FARMACEUTICI ECOBIS.A.S

ITALY

FLOGOFENAC SOLUTION FORINJECTION

75MG/3ML FARMACEUTICI ECOBISAS

ITALY

FLOGOFENAC RETARD CAPSULE 100MG FARMACEUTICI ECOBISAS

ITALY

FLOGOPROFEN GEL 5G/100G CHIESI WASSERMANNS.A.

SPAIN

FLOGOPROFEN SOLUTION 5G/100ML CHIESI WASSERMANNS.A.

SPAIN

FLOGOPROFEN SOLUTION 5G/100ML CHIESI ESPANA S.A. SPAIN

FLOGOPROFEN GEL GEL 5G/100G CHIESI ESPANA S.A. SPAIN

FLOLAN SOLUTION FORINJECTION

0.5MG/2ML THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

FLOLAN POW AND SOL F/IV INF. 0.5MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

FLOMIST SPRAY N/A CIPLA LTD INDIA

FLONITAL CAPSULE 20MG ANFARM HELLAS S.A. GREECE

FLORINEF TABLETS 0.1MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

FLOXAPEN CAPSULES 250MG CAPSULE 250MG BEECHAM GROUP PLC UNITED KINGDOM

FLOXAPEN CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC UNITED KINGDOM

FLOXAPEN SYRUP POWDER FOR ORALSOLUTION

250MG/5ML BEECHAM GROUP PLC UNITED KINGDOM

FLOXAPEN SYRUP POWDER F/SOL F/INJECTIONI

125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM

FLOXAPEN SYRUP 125MG/5ML POWDER FOR ORALSOLUTION

125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM

FLOXAPEN VIALS FOR INJECTION250MG

POWDER FOR INJECTION 250MG BEECHAM GROUP PLC UNITED KINGDOM

FLU RELIEF CAPSULES WITHDECONGESTANT

CAPSULE N/A GALPHARMHEALTHCARE LIMITED

UNITED KINGDOM

FLUANXOL TABLET 0.5MG H. LUNDBECK A/S DENMARK

FLUANXOL DEPOT INJECTION100MG/ML

SOLUTION FORINJECTION

100MG/ML H. LUNDBECK A/S DENMARK

FLUANXOL DEPOT INJECTION20MG/ML

SOLUTION FORINJECTION

20MG/ML H. LUNDBECK A/S DENMARK

FLUARIX (INFLUENZA SPLITVACCINE)

SUSP. FOR IM/SCINJECTION

N/A SACHSISCHESSERUMWERK DRESDEN(SMITHKLINE BEECHAMPHARMA)

GERMANY

EL562 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FLUARIX INFLUENZA SPLITVACCINE

SUSPENSION F IM SC INJ. NA SACHSISCHESSERUMWERK DRESDEN

GERMANY

FLUCLOXACILLIN ORAL ELIXIR 125MG/5ML KENTPHARMACEUTICALSLIMITED

UNITED KINGDOM

FLUCLOXACILLIN CAPSULES 250MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

FLUCLOXACILLIN CAPSULES 500MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

FLUCLOXACILLIN ELIXIR 125MG/5ML NORTON HEALTHCARELIMITED

UNITED KINGDOM

FLUCLOXACILLIN CAPSULES B.P. CAPSULES 250MG ATHLONELABORATORIES LIMITED

IRELAND

FLUCORAL 150MG CAPSULES CAPSULES 150MG BILIM ILAC SANAYII VETICARET A.S.

TURKEY

FLUCOZAL 100 CAPSULES 100MG AEGIS LTD CYPRUS

FLUCOZAL 150 CAPSULE 150MG AEGIS LTD. CYPRUS

FLUCOZAL 200 CAPSULES 200MG AEGIS LTD CYPRUS

FLUCOZAL 50 CAPSULES 50MG AEGIS LTD CYPRUS

FLUDARA POWDER FOR INJECTION 50MG SCHERING AG GERMANY

FLUDARA ORAL FILM COATED TABLET 10MG SCHERING HEALTH CARELIMITED

UNITED KINGDOM

FLUDITEC 5% EXPECTORANT,SYRUP F/ADULTS

ORAL SUSPENSION 5% INNOTECHINTERNATIONAL

FRANCE

FLUIFORT SYRUP N/A DOMPE FARMACEUTICI ITALY

FLUMETOL EYE DROPS N/A FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

FLUMETOL 'ANTIBIOTICO' EYE DROPS, POWD.+SOLVENT

N/A FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

FLUMETOL 'SEMPLICE' EYE DROPS 0.2% W/V FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

FLUNIL-10 CAPSULES 10MG INTASPHARMACEUTICALSLIMITED

INDIA

FLUNIL-10 10MG CAPSULES INTASPHARMACEUTICALS LTD

INDIA

FLUNIL-20 CAPSULE 20MG INTASPHARMACEUTICALS LTD

INDIA

FLUNIL-20 CAPSULES 20MG INTASPHARMACEUTICALS LTD

INDIA

FLUOCIM CAPSULES 20MG CIMEX AG SWITZERLAND

FLUORESCEIN SODIUM 2% EYE DROPS 2% CHAUVINPHARMACEUTICALSLIMITED

UNITED KINGDOM

FLUORESCEINE 10% SOLUTION FORINJECTION

100MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 563

Trade Name Dosage Form Dose MA Holder Country

FLUORESCEINE SODIQUE FAURE SOLUTION FORINJECTION

10% W/V CIBA VISIONOPHTHALMICS

FRANCE

FLUORETS OPHTHALMIC STRIPS 1MG/STRIP CHAUVINPHARMACEUTICALS LTD.

UNITED KINGDOM

FLUORORINIL NASAL SPRAY,SUSPENSION

N/A FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

FLUOROURACIL INJECTION BP SOLUTION FORINJECTION

25MG/ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

FLUOROURACIL INJECTION BP SOLUTION FORINJECTION

50MG/ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

FLUOROURACIL INJECTION VIAL SOLUTION FORINJECTION

250MG/10ML F.H. FAULDING & CO.LTD. (T/A DAVID BULLLABS)

UNITED KINGDOM

FLUOTHANE LIQUID FORINHALATION

0.01% W/W ZENECA LIMITED UNITED KINGDOM

FLUOTHANE CONCENTRATE FOR INH.SOL.

100% W/W ZENECA LIMITED UNITED KINGDOM

FLUOXETIN DELTA 10MGCAPSULES

CAPSULES DELTA HF — ICELAND ICELAND

FLUOXETIN DELTA 20 MG CAPSULE 20MG DELTA HF ICELAND

FLUPHENAZINE DECANOATE SOLUTION FORINJECTION

25MG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

FLUPHENAZINE DECANOATE INJ.BP 100MG/ML

SOLUTION FORINJECTION

100MG/ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

FLUPHENAZINE DECANOATEINJECTION

SOLUTION FORINJECTION

25MG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

FLUPHENAZINE DECANOATEINJECTION

SOLUTION FORINJECTION

100MG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

FLUPHENAZINE DECANOATEINJECTION BP

SOLUTION FORINJECTION

100MG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

FLUSEMINAL F.C. TABLET 400MG ANFARM HELLAS S.A. GREECE

FLUSENIL CAPSULE 50MG ANFARM HELLAS S.A. GREECE

FLUSENIL CAPSULE 150MG ANFARM HELLAS S.A. GREECE

FLUSOLV SOLUTION FORINJECTION

12500IU/0.5ML FARMACEUTICI ECOBISAS

ITALY

FLUTAMIDA TABLETS 250MG LEMERY S.A. MEXICO

FLUTAMIDE TAB 250MG TABLET 250MG PHARMASCIENCE INC. CANADA

FLUTAMIDE TABLETS 250MG TABLET 250MG GENERICS (UK) LIMITED UNITED KINGDOM

FLUTAN 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

FLUVIRAL S/F SUS IM SUSPENSION FORINJECTION

N/A BIOCHEM VACCINES INC. CANADA

FLUVOXAMINE TABLETS 100MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

EL564 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FLUVOXAMINE TABLETS BP100MG

TABLET 100MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

FLUXIL 20 CAPSULES 20MG AEGIS LTD, CYPRUS

FLUZOLE 50MG 7 CAPSULE CAPSULE 50MG BIOFARMA ILAC SAN.VETIC.A.S.

TURKEY

FML LIQUIFILM STERILE OPHTHAL.SUSPEN.

1MG/ML ALLERGANPHARMACEUTICALS(IRELAND) LTD., INC.

IRELAND

FOBAN OINTMENT 2% W/W HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

FOBAN CREAM 2% W/W HOE PHARMCEUTICALSSDN. BHD.

MALAYSIA

FOBAN CREAM 2% W/W HOE PHARMACEUTICALSSDN BHD

MALAYSIA

FOBAN OINTMENT 2% W/W HOE PHARMACEUTICALSSDN BHD

MALAYSIA

FOBAN CREAM CREAM 2%W/W HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

FOBAN OINTMENT OINTMENT 2% W/W HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

FOBANCORT OINTMENT N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

FOBANCORT CREAM N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

FOBANCORT CREAM N/A HOE PHARMACEUTICALSSDN BHD

MALAYSIA

FOBANCORT OINTMENT N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

FOBANCORT OINTMENT OINTMENT N/A HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

FOLIC ACID TABLETS 5MG REMEDICA LTD CYPRUS

FOLIC ACID TABLETS 5MG PHARMAMED LTD. MALTA

FOLIC ACID BP 5MG TABLET 5MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

FOLIC ACID TABLETS TABLET 5MG CAMDEN INDUSTRIES (M)SDN. BHD

MALAYSIA

FOLIC ACID TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

FOLIC ACID TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

FOLIFER PROLONGED RELEASETABLET

NA LABORATORIOS BIAL —PORTELA & CA, S.A.

PORTUGAL

FOLIFER PROLONGED RELEASETABLET

NA LABORATORIOS BIAL —PORTELA & CA, S.A.

PORTUGAL

FORADIL POWDER CAPS. FORINHAL.

12MCG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 565

Trade Name Dosage Form Dose MA Holder Country

FORADIL POWDER FORINHALATION

12MCG NOVARTIS PHARMAS.P.A.

ITALY

FORAL LOZENGE N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

FORANE CONC. FOR INHALATIONSOL.

99.9% W/W ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

FORCEVAL CAPSULES CAPSULE N/A UNIGREG LIMITED UNITED KINGDOM

FORCEVAL JUNIOR CAPSULES CAPSULE N/A UNIGREG LIMITED UNITED KINGDOM

FORCEVAL PROTEIN POWDER POWDER FOR ORALSOLUTION

N/A UNIGREG LIMITED UNITED KINGDOM

FORCID SOLUTAB TABLETS 125/31,25 YAMANOUCHI PHARMAB.V.

NETHERLANDS

FORCID SOLUTAB TABLETS 250/62,50 YAMANOUCHI PHARMAB.V.

NETHERLANDS

FORCID SOLUTAB TABLETS 375/93,75 YAMANOUCHI PHARMAB.V.

NETHERLANDS

FORCID SOLUTAB TABLETS 500/125 YAMANOUCHI PHARMAB.V.

NETHERLANDS

FORECOX TABLETS N/A MALCEODSPHARMACEUTICALS LTD

INDIA

FORECOX-TRAC TABLET N/A MACLEODSPHARMACEUTICALS LTD

INDIA

FORMOMICIN OPTHALMIC DROPS N/A FARMIGEA SPA ITALY

FORMOMICIN OPHTHALMIC OINTMENT N/A FARMIGEA SPA ITALY

FORSEF 1G IM POWDER F/SOLUTION F/INJ

1G BILIM ILAC SANAYII VETICARET A.S

TURKEY

FORSEF 1G IV POWDER F/SOLUTION F/INJ

1G BILIM ILAC SANAYII VETICARET A.S.

TURKEY

FORTOVASE CAPSULE 200MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

FORTRAL CAPSULES 50MG CAPSULE 50MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

FORTRAL INJECTION 30MG/ML SOLUTION FORINJECTION

3.947% W/V SANOFI WINTHROPLIMITED

UNITED KINGDOM

FORTUM 1G/3ML POWDER AND SOL FORINJ.

1164MG GLAXOSMITHKLINE S.P.A ITALY

FORTUM 500MG/1.5ML POWDER AND SOL FORINJ.

582MG GLAXOSMITHKLINE S.P.A ITALY

FORTUM FOR INJECTION POWDER FOR INJECTION 1G GLAXO OPERATIONS UKLIMITED

UNITED KINGDOM

FORTUM FOR INJECTION POWDER FOR INJECTION 500MG GLAXO OPERATIONS UKLIMITED

UNITED KINGDOM

FORTUM INJECTION 1G POWDER FOR INJECTION 1G GLAXO OPERATIONS UKLTD

UNITED KINGDOM

FORTUM INJECTION 250MG POWDER FOR INJECTION 250MG GLAXO OPERATIONS UKLTD

UNITED KINGDOM

FORTUM INJECTION 2G POWDER FOR INJECTION 2G GLAXO OPERATIONS UNITED KINGDOM

EL566 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FORTUM INJECTION 500MG POWDER FOR INJECTION 500MG GLAXO OPERATIONS UKLTD

UNITED KINGDOM

FORTZAAR 100/25MG TABLETS 100/25MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

FOSAMAX 10MG TABLET 10MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

FOSAMAX, ONCE WEEKLY TABLETS 70MG MERCK SHARP & DOHMELTD.

UNITED KINGDOM

FRAGMIN SOLUTION FORINJECTION

25,000IU PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

FRAGMIN SOLUTION FORINJECTION

2500IU/ML PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

FRAGMIN SOLUTION FORINJECTION

10000IU/1ML PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

FRAGMIN SOLUTION FORINJECTION

2500IU/ML PHARMACIA NV/SA BELGIUM

FRAGMIN SOLUTION FORINJECTION

12 500IU/ML PHARMACIA SVERIGE AB SWEDEN

FRAGMIN SOLUTION FORINJECTION

7500IU/0.3ML PHARMACIA NV/SA BELGIUM

FRAGMIN 2500IU (ANTI-XA)/ML SOLUTION FORINJECTION

2500IU/ML PHARMACIA NV/SA BELGIUM

FRAGMIN 2500IU/0.2ML SOLUTION FORINJECTION

2500IU/02ML PHARMACIA NV/SA BELGIUM

FRAGMIN 5000IU/0.2ML SOLUTION FORINJECTION

5000IU/0.2ML PHARMACIA NV/SA BELGIUM

FRAXIPARINE 2850 UI AXA/0.3ML SOLUTION FORINJECTION

2850 IU/0.3ML SANOFI WINTHROP FRANCE

FRAXIPARINE 3800 IU AXA/0.4ML INJ. SOLUTION 3800IU SANOFI SYNTHALABOFRANCE

FRANCE

FRAXIPARINE 5700 UI AXA/0.6ML SOLUTION FORINJECTION

5700 IU/0.6ML SANOFI WINTHROP FRANCE

FRAXIPARINE 7600 UI/AXA/0.8ML SOLUTION FORINJECTION

7600 IU/0.8ML SANOFI WINTHROP FRANCE

FRAXIPARINE FORTE INJECTABLE SOLUTION(PFS)

11400 IU/0.6ML SANOFI WINTHROP FRANCE

FRAXIPARINE FORTE INJECTABLE SOLUTION(PFS)

15200 IU/0.8ML SANOFI WINTHROP FRANCE

FRAXIPARINE FORTE INJECTABLE SOLUTION(PFS)

19000IU/1ML SANOFI WINTHROP FRANCE

FRIARS BALSAM BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM

FROMILID FILM-COATED TABLET 250MG KRKA, D.D., NOVOMESTO

SLOVENIA

FROXIME TABLETS 250MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

FROXIME SUSPENSION 125MG/5ML DAR AL DAWADEVELOPMENT ANDINVESTMENT

JORDAN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 567

Trade Name Dosage Form Dose MA Holder Country

FRU-CO TABLETS N/A NORTON HEALTHCARELIMITED

UNITED KINGDOM

FRUMIL TABLET N/A HELIOS HEALTHCARELIMITED

GREECE

FRUMIL TABLET N/A HELIOS HEALTHCARELIMITED

UNITED KINGDOM

FRUSEMIDE TABLET 40MG GENERICS (UK) LIMITED— UK

UNITED KINGDOM

FRUSEMIDE INJECTION BP SOLUTION FORINJECTION

50MG/ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

FRUSEMIDE BP TABLET 40MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

FRUSEMIDE INJ MINIJET AQUEOUS SOLUTION 10MG/ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

FRUSEMIDE INJECTION SOLUTION FORINJECTION

20MG/2ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

FRUSEMIDE INJECTION BP SOLUTION FORINJECTION

250MG/25ML ANTIGENPHARMACEUTICALS LTD

IRELAND

FRUSEMIDE INJECTION BP SOLUTION FORINJECTION

20MG/2ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

FRUSEMIDE INJECTION BP SOLUTION FORINJECTION

250MG/ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

FRUSEMIDE INJECTION BP MINIJET SOLUTION FORINJECTION

10MG/ML INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

FRUSEMIDE TABLET 40MG TABLET 40MG CAMDEN INDUSTRIES (M)SDN. BHD

MALAYSIA

FRUSEMIDE TABLET BP 40MGAMEDOSIX

TABLET 40MG TABLETS (INDIA) LIMITED INDIA

FRUSEMIDE TABLETS BP TABLET 40MG IPCA LABORATORIESLIMITED

INDIA

FRUSEMIDE TABLETS BP 40MG TABLET 40MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

FUCICORT CREAM N/A LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCICORT CREAM N/A LEO PAKISTAN

FUCICORT CREAM N/A LEO PAKISTAN

FUCIDIN SUSPENSION 50MG/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCIDIN CREAM 20MG/G LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCIDIN GEL 20MG/G LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCIDIN OINTMENT 20MG/G LEO PHARMACEUTICALPRODUCTS

DENMARK

EL568 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FUCIDIN TABLETS 250MG LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCIDIN CREAM N/A LEO PAKISTAN

FUCIDIN OINTMENT 20MG/G LEO PAKISTAN

FUCIDIN CREAM 20MG/G LEO PAKISTAN

FUCIDIN OINTMENT 20MG/G LEO PAKISTAN

FUCIDIN H CREAM N/A LEO LABORATORIESLIMITED

UNITED KINGDOM

FUCIDIN H CREAM N/A LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCIDIN H CREAM CREAM NA LEO PAKISTAN

FUCIDIN I.V. POWDER FOR INFUSION N/A LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCIDIN INTERTULLE GAUZE INPREG. W/OINTMENT

20MG/100CM2 LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCIDIN INTERTULLE GAUZE IMP. WITHOINTMENT

30MG/100CM2 LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCIDIN-H CREAM N/A LEO PAKISTAN

FUCITHALMIC VISCOUS EYE DROPS 10MG/G LEO PHARMACEUTICALPRODUCTS

DENMARK

FUCITHALMIC VISCOUS EYE DROPS 10MG/G LEO PAKISTAN

FUCITHALMIC DROPS EYE DROPS 1%W/W LEO PAKISTAN

FUGENTIN TABLET N/A ELPEN S.A. GREECE

FUGENTIN POWD. ORALSUSPENSION

N/A ELPEN S.A. GREECE

FUGENTIN POWD. FOR ORALSUSPENSION

N/A ELPEN PHARM. CO. INC. GREECE

FULCIN TABLET 125MG ZENECA LIMITED UNITED KINGDOM

FULCIN TABLET 500MG ZENECA LIMITED UNITED KINGDOM

FULCIN ORAL SUSPENSION 2.5%W/V ZENECA LIMITED UNITED KINGDOM

FULL MARKS LOTION TOPICAL SOLUTION 0.2% W/V SETON PRODUCTSLIMITED

UNITED KINGDOM

FUNGILIN LOZENGES 10MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

FUNGILIN ORAL TABLETS 100MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

FUNGILIN ORAL SUSPENSION 100MG/ML E.R. SQUIBB & SONS LTD UNITED KINGDOM

FUNGO POWDER POWDER 2% W/W EGO PHARMACEUTICALS AUSTRALIA

FUNGO SOLUTION SOLUTION 2% W/W EGO PHARMACEUTICALS AUSTRALIA

FUNGO SOOTHING BALM BALM N/A EGO PHARMACEUTICALS AUSTRALIA

FUNGO VAGINAL CREAM CREAM 2% W/W EGO PHARMACEUTICALS AUSTRALIA

FUNGOCORT CREAM N/A EGO PHARMACEUTICALS AUSTRALIA

FUNGOTOX CREAM 10MG/G MEPHA PHARMA AG SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 569

Trade Name Dosage Form Dose MA Holder Country

FURANTOINA TABLET 50MG J.URIACH & CIA. S.A. SPAIN

FUROSEMIDE SOLUTION FORINJECTION

10MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

FUROSEMIDE SOLUTION FORINJECTION

20MG/2ML PHARMAMEDPARENTERALS LTD.

MALTA

FUROSEMIDE INJECTION USP SOLUTION FORINJECTION

10MG/1ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

FUROSEMIDE/FRUSEMIDE (FUSID)TABLETS

TABLET 40MG TEVA PHARMACEUTICALINDUSTRIES LTD

ISRAEL

FUROSEMID-SLOVAKOFARMATABLETS

TABLET 40 MG SLOVAKOFARMA A.S.HLOHOVEC

SLOVAK REPUBLIC

FYBOGEL LEMON GRANULES FOR ORALSOLN.

3.5G RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

FYBOGEL LEMON GRANULES F/ORAL SOL. 3.5G RECKITT BENCKISERHEALTHCARE(UK)LIMITED

UNITED KINGDOM

FYBOGEL MEBEVERINE EFF.GRANULES F/ORALSUSP.

N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

FYBOGEL ORANGE EFFERVESCENTGRANULES

3.5G RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

FYBOGEL ORANGE EFF.GRANULES 3.5GM RECKITT BENCKISERHEATHCARE(UK)LIMITED

UNITED KINGDOM

G.P.O. (4% ALBUMIN) SOLUTION FORINFUSION

40G/L CLB NETHERLANDS

GADIN TABLETS 150MG UNIMEDPHARMACEUTICALS INC.

KOREA REPUBLIC

GADIN (RANITIDINEHYDROCHLORIDE)

SOLUTION FORINJECTION

50MG/2ML UNIMEDPHARMACEUTICALS INC

KOREA REPUBLIC

GADOVIST 1.0MMOL/ML SOLUTION FORINJECTION

1.0MMOL/ML SCHERING AG GERMANY

GALENAMOX CAPSULES 250MG BP GALEN LIMITED UNITED KINGDOM

GALENAMOX GRANULES FOR ORALSOL.

125MG/5ML GALEN LIMITED UNITED KINGDOM

GALENAMOX GRANULES FOR ORALSOL.

250MG/5ML GALEN LIMITED UNITED KINGDOM

GALENOMOX CAPSULES 500MG BP GALEN LIMITED UNITED KINGDOM

GALFER ORAL SOLUTION 140MG/5ML GALEN LIMITED UNITED KINGDOM

GALFER FA CAPSULES N/A GALEN LIMITED UNITED KINGDOM

GALLIUM CITRATE (67GA) SOLUTION FORINJECTIONS

37MBQ/ML NYCOMED AMERSHAMPLS

UNITED KINGDOM

GALPAMOL ORAL SUSPENSION 120MG/5ML HEALTHY IDEAS LIMITED UNITED KINGDOM

GALPHARM HAYFEVER ANDALLERGY RELIEF

FILM COATED TABLET 10MG APPROVEDPRESCRIPTION SERVICESLIMITED

UNITED KINGDOM

GALPROFEN IBUPROFEN COLDAND FLU

COATED TABLET 200MG GALPHARMHEALTHCARE LIMITED

UNITED KINGDOM

EL570 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

GALPROFEN LONG LASTINGIBUPROFEN CAPSULE

MODIFIED RELEASECAPSULE

200MG HEALTHY IDEAS LIMITED UNITED KINGDOM

GAMALATE B6 COATED TABLETS N/A LABORATORIOS NOVAG,S.A.

SPAIN

GAMALATE B6 SOLUTION N/A LABORATORIOS NOVAG,S.A.

SPAIN

GAMIMUNE N, 10% SOLUTION FOR IVINJECTION

10% W/V BAYER CORPORATION,PHARMACEUTICALDIVISION

UNITED STATES OFAMERICA

GAMIMUNE N, 5% SOLUTION FOR IVINJECTION

5% W/V BAYER CORPORATION,PHARMACEUTICALDIVISION

UNITED STATES OFAMERICA

GAMMAGLOBULIN PHARMACIA SOLUTION FORINJECTION

165MG/1ML PHARMACIA & UPJOHNAB

SWEDEN

GAMMAGLOBULIN PHARMACIA SOLUTION FORINJECTION

165MG/ML BIOVITRUM AB SWEDEN

GAMMONATIV POWDER FOR INFUSION (I+II) 2.5G PHARMACIA & UPJOHNAB

SWEDEN

GAMMONATIV POWDER FOR INFUSION (I+II) 5G PHARMACIA & UPJOHNAB

SWEDEN

GAMMONATIV POWDER ANDSOLVENT

POWDER AND SOLVENT 2.5G BIOVITRUM SWEDEN

GANAZOLO VAGINAL CREAM 1% W/W ISTITUTO GANASSINIS.P.A DI RICERCHEBIOCHIMICHE

ITALY

GANAZOLO VAGINAL OVULES 150MG ISTITUTO GANASSINIS.P.A. DI RICERCHEBIOCHIMICHE

ITALY

GARAMYCIN OINTMENT 0.1% W/W S-P CANADA CANADA

GARAMYCIN 0.1% CREAM 0.1% W/W S-P CANADA CANADA

GARASONE EYE OINTMENT N/A SCHERING-PLOUGHNV/SA

BELGIUM

GARASONE EYE/EAR DROPS N/A SCHERING-PLOUGH S.A. BELGIUM

GASTROBID CONTINUS TABLETS15MG

MODIFIED RELEASETABLETS

15MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

GASTROFAIT TABLETS 1G EGYPTIANINTERNATIONALPHARMACEUTICALINDUSTRIES CO.

EGYPT

GASTROGRAFIN SOLUTION N/A SCHERING ESPANA, S.A. SPAIN

GASTRONERTON TABLET 8.92MG DOLORGIET GMBH & CO.KG

GERMANY

GASTRONERTON TABLET 8.92MG/TABLET DOLORGEIT GMBH & COKG

GERMANY

GASTRONERTON SYRUP SOLUTION 116.2MG/100ML DOLORGIET GMBH & CO.KG

GERMANY

GASTROPRIDE SUSPENSION 5MG/5ML DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 571

Trade Name Dosage Form Dose MA Holder Country

GAVISCON LIQUID N/A RECKITT & COLMAN PAKISTAN

GAVISCON ADVANCE ORAL SUSPENSION N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

GAVISCON INFANT POWDER FOR ORALSOLUTION

N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

GAVISCON LIQUID LIQUID N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

GAVISCON LIQUID LIQUID NA RECKITT & BENCKISER PAKISTAN

GAVISCON LIQUID PEPPERMINT ORAL SUSPENSION N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

GAVISCON LIQUID SACHETS ORAL SUSPENSION N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

GAVISCON PEPPERMINTFLAVOUR

CHEWABLE TABLET N/A RECKITT & COLMAN PAKISTAN

GAVISCON TABLETS TABLET N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

GAVISCON TABLETS TABLETS NA RECKITT & BENCKISER PAKISTAN

GAVISCON TOFFEE FLAVOUR CHEWABLE TABLET N/A RECKITT & COLMAN PAKISTAN

GEE'S LINCTUS BP/SQUILL OPIATELINQTUS

ORAL SOLUTION N/A LCM LTD UNITED KINGDOM

GELAFUNDIN INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

GELCOTAR LIQUID SHAMPOO N/A QUINODERM LIMITED UNITED KINGDOM

GEL-LARMES OPHTHALMIC GEL 0.3G / 100G LABORATOIRES THEA FRANCE

GELOFUSINE SOLUTION FORINFUSION

4% W/V B.BRAUN MELSUNGENAG

GERMANY

GELOMYRTOL CAPSULES 120MG G. POHL-BOSKAMPGMBH & CO

GERMANY

GELOMYRTOL FORTE CAPSULE 300MG G. POHL-BOSKAMPGMBH & CO

GERMANY

GEMZAR POWDER FOR IVINJECTION

200MG LABORATOIRES LILLYFRANCE

FRANCE

GEMZAR POWDER FOR IVINJECTION

1000MG LABORATOIRES LILLYFRANCE S.A.

FRANCE

GENELAC ORAL SOLUTION 100%W/V GENERICS (UK) LTD. UNITED KINGDOM

GENOTROPIN (I + II) 16IU POWDER FOR INJECTION N/A PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

GENOTROPIN (I + II) 36IU POWDER FOR INJECTION N/A PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

GENOTROPIN, POWDER ANDSOLVENT

POWDER AND SOLVENT 16IU(5.3MG) PHARMACIA SVERIGE AB SWEDEN

GENOVOX FILM COATED TABLETS 30MG KLEVA LTD. GREECE

GENOVOX FILM COATED TABLETS 30MG KLEVA LIMITED GREECE

EL572 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

GENTADAR EYE/EAR DROPS N/A DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

GENTAMED 80MG/2ML LIQUID FOR INJECTION 80MG/2ML MEDOCHEMIE LTD CYPRUS

GENTAMICIN SOLUTION FORINJECTION

80MG/2ML KRKA, D.D., NOVOMESTO

SLOVENIA

GENTAMICIN INJECTION IP 40MG CIPLA LTD — INDIA INDIA

GENTAMICIN - POS EYEDROPS EYE DROPS N/A URSAPHARMARZNEIMITTEL GMBHAND CO KG —GERMANY

GERMANY

GENTAMICIN SULFATE SOLUTION FORINJECTION

80MG/2ML PHARMAMEDPARENTERALS LTD.

MALTA

GENTAMICIN SULFATE INJECTIONUSP

SOLUTION F/INJECTION 40MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

GENTAMICIN SULPHATE SOL. FORINJECTION

SOLUTION FORINJECTION

40MG/ML TABLETS (INDIA) LIMITED INDIA

GENTAMICINE (ESSEX GENTA) SOLUTION FORINJECTION

80MG/2ML SCHERING-PLOUGH S.A. BELGIUM

GENTAMYCIN INJECTION 80MG/2ML WAN WEI YAO ZHUNZI CHINA

GENTAMYCIN INJECTION SOLUTION FORINJECTION

80MG/2ML FAULDINGPHARMACEUTICALS

UNITED KINGDOM

GENTAMYTREX OPHTHALMIC OINTMENT 3MG/1G DR. GERHARD MANNCHEM-PHARM FABRIKGMBH

GERMANY

GENTAMYTREX IN DER OPHTIOLE EYE DROPS 5MG/ML DR. GERHARD MANN,CHEM.-PHARM.FABRIKGMBH

GERMANY

GENTATRIM OINTMENT 0.1%W/W TRIMA ISRAELPHARMACEUTICALPRODUCTS LIMITED

ISRAEL

GENTIBIOPTAL EYE DROPS 441MG/100ML FARMILA FARMCEUTICIMILANO S.P.A.

ITALY

GENTRAN 70 INTRAVENOUSINFUSION

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

GEOERYTHCIN TABLET 250MG GEOFMANPHARMACEUTICALS

PAKISTAN

GEOMOXIN SUSPENSION 125MG/5ML GEOFMANPHARMACEUTICALS

PAKISTAN

GEOMYCIN/GARAMYCIN EYE/EAR DROPS 3MG/ML SCHERING-PLOUGH S.A. BELGIUM

GERARD BLUE FLAG ROOTCOMPOUND TABLETS

TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD BUCHU COMPOUNDTABLETS

TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD HELONIAS COMPOUNDTABLETS

COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD HOUSE SOMNUS COATED TABLET N/A CATHAY OFBOURNEMOUTH LIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 573

Trade Name Dosage Form Dose MA Holder Country

GERARD HOUSE CATARRH EEZE TABLET N/A PETER BLACKHEALTHCARE

UNITED KINGDOM

GERARD HOUSE ECHINACEA +GARLIC TABLETS

COATED TABLET N/A CATHAY OFBOURNEMOUTH LTD

UNITED KINGDOM

GERARD HOUSE REUMALEXTABLETS

COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD HOUSE SERENITY COATED TABLET N/A CATHAY OFBOURNEMOUTH LIMITED

UNITED KINGDOM

GERARD HOUSE SLIMMERS AID TABLETS N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD HOUSE WATER RELIEFTABLETS

COATED TABLETS N/A PETER BLACKHEALTHCARE LIMITED

UNITED KINGDOM

GERARD KELP TABLETS 360MG TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD PAPAYA PLUS TABLETS COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD SLIPPERY ELM TABLETS TABLET 400MG GERARD HOUSE LIMITED UNITED KINGDOM

GERIAVIT PHARMATON(PHARMATON CAPSULES)

CAPSULE N/A PHARMATON SA SWITZERLAND

GERMACID OINTMENT 2% W/W RAZA MANUFACTURINGBERHAD

MALAYSIA

GERMOLENE ANTISEPTICOINTMENT

OINTMENT N/A BAYER PLC T/A BAYERPLC CONSUMERDIVISION

UNITED KINGDOM

GERMOLOIDS OINTMENT N/A BAYERPLC/BAYERPLCCONSUMER CAREDIVISION

UNITED KINGDOM

GERMOLOIDS COMPLETESUPPOSITORY

SUPPOSITORY N/A BAYER PLC T/A BAYERPLC CONSUMER CAREDIVISION

UNITED KINGDOM

GERMOLOIDS SUPPOSITORIES SUPPOSITORY N/A BAYER PLCT/A BAYERPLC CONSUMER CAREDIVISION

UNITED KINGDOM

GESTONE 100MG/2ML SOLUTION FORINJECTION

100MG/2ML FERRINGPHARMACEUTICALSLIMITED

UNITED KINGDOM

GESTONE 25MG/ML SOLUTION FORINJECTION

25MG/ML FERRINGPHARMACEUTICALSLIMITED

UNITED KINGDOM

GESTONE 50MG/ML SOLUTION FORINJECTION

50MG/ML FERRINGPHARMACEUTICALSLIMITED

UNITED KINGDOM

GF-125 TABLETS 125MG CAMDEN INDUSTRIES (M)SDN. BHD

MALAYSIA

GINCOSAN HARD GELATINECAPSULES

N/A PHARMATON SA SWITZERLAND

GINESAL VAGINAL SOLUTION NA FARMIGEA SPA ITALY

GINGIVITOL N SOLUTION 8.78MG/1G HENNIG ARZNEIMITTELGMBH & CO. KG

GERMANY

GINORECTOL FILM COATED TABLETS 250MG KLEVA LIMITED GREECE

GINORECTOL FILM COATED TABLETS 500MG KLEVA LIMITED GREECE

EL574 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

GINSANA CAPSULE 100MG BOEHRINGER INGELHEIMLIMITED

UNITED KINGDOM

GIVALEX MOUTH WASH N/A LABORATOIRESNORGINE PHARMA

FRANCE

GIVALEX MOUTHWASH N/A LABORATOIRESNORGINE PHARMA

FRANCE

GIVALEX MOUTHWASH N/A LABORATOIRESNORGINE PHARMA

FRANCE

GLABINOL TABLET 5MG GEOFMANPHARMACEUTICALS

PAKISTAN

GLADLAX TABLETS TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GLIBENCLAMIDE TABLETS 2.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

GLIBENCLAMIDE TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

GLIBENCLAMIDE TABLETS 5MG PHARMAMED LTD. MALTA

GLIBENCLAMIDE TABLETS 5MG EGYPTIANINTERNATIONALPHARMACEUTICALINDUSTRIES CO (EIPICO)

EGYPT

GLIBENCLAMIDE TABLETS BP2.5MG

TABLETS 2.5MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

GLIBENCLAMIDE TABLETS BP2.5MG

TABLET 2.5MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

GLIBENCLAMIDE TABLETS BP5MG

TABLETS 5MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

GLIBENCLAMIDE TABLETS BP5MG

TABLET 5MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

GLIBESYN 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

GLIBOMET FILM-COATED TABLETS NA LABORATORI GUIDOTTISPA

ITALY

GLICEROLO SUPPOSITORIES 2500MG PIETRASANTA PHARMAS.R.L.

ITALY

GLICEROLO SUPPOSITORIES 2250MG LABORATORIO CHIMICOFARMACEUTICO A.SELLA S.R.L.

ITALY

GLIMICRON 80MG TABLET 80MG HOVID SDN. BHD MALAYSIA

GLITISOL TABLETS 5MG REMEDICA LTD CYPRUS

GLIVEC HARD CAPSULES 50MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

GLIVEC HARD CAPSULES 100MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

GLIVEC HARD CAPSULES 50MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

GLIVEC HARD CAPSULES 100MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

GLORYFEN DR.PD.INJ. 1G/VIAL HELP A.B.E.E. GREECE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 575

Trade Name Dosage Form Dose MA Holder Country

GLUCAGEN 1MG HYPOKITINJECTION

POWDER F/INJ ANDSOLVENT

1MG/1ML NOVO DORDISK A/S DENMARK

GLUCAGEN INJECTION POWDER F/INJ ANDSOLVENT

1MG/1ML NOVO NORDISK A/S DENMARK

GLUCOBAY 100 TABLET 100MG BAYER VITAL GMBH &CO. KG

GERMANY

GLUCOBAY 100MG TABLETS 100MG BAYER PAKISTAN

GLUCOBAY 50 TABLET 50MG BAYER VITAL GMBH &CO. KG

GERMANY

GLUCOBAY 50MG TABLET 50MG BAYER PAKISTAN

GLUCOMET FILM COATED TABLETS 500MG,850MG DOUGLASPHARMACEUTICALSLIMITED

NEW ZEALAND

GLUCOPHAGE 500MG FILM-COATED TABLET 500MG LIPHA SANTE FRANCE

GLUCOPHAGE 850MG FILM-COATED TABLET 850MG LIPHA SANTE FRANCE

GLUCOSE SOLUTION FORINJECTION

20% W/VBP GALEN RESEARCHLABORATORIES LIIMITED

UNITED KINGDOM

GLUCOSE SOLUTION FORINJECTION

50% W/V BP IVEX PHARMACEUTICALSLIMITED

UNITED KINGDOM

GLUCOSE 20%W/V INTRAVENOUSINFUSION BP

SOLUTION FORINJECTION

20%W/V GALEN RESEARCHLABORATORIES

UNITED KINGDOM

GLUCOSE 50% W/VINTRAVENOUS INFUSION

SOLUTION FORINJECTION

50%W/V IVEX PHARMACEUTICALSLIMITED

UNITED KINGDOM

GLUCOSE INJECTION MINIJET50%W/V

AQUEOUS SOLUTION 500MG/ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

GLUCOSE INJECTION BP MINIJET SOUTION FOR INJECTION 50%W/V INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

GLUCOSE INTRAVENOUSINFUSION

SOLUTION FORINFUSION

50%W/V BAXTER HEALTHCARELIMITED

UNITED KINGDOM

GLUCOSE INTRAVENOUSINFUSION

SOLUTION FORINJECTION

10%W/V BAXTER HEALTHCARELIMITED

UNITED KINGDOM

GLUCOSE INTRAVENOUSINFUSION

SOLUTION FORINJECTION

20%W/V BAXTER HEALTHCARELIMITED

UNITED KINGDOM

GLUCOSE IV INFUSION SOLUTION FORINFUSION

5%W/V BAXTER HEALTHCARELIMITED

UNITED KINGDOM

GLUMET-500 TABLET 500MG CIPLA LIMITED INDIA

GLYCERIN (GLYCEROL BP) ORAL SOLUTION 100% V/V WILLIAM RANSOM &SON PLC

UNITED KINGDOM

GLYCERIN BP ORAL SOLUTION 100% V/V LVM LTD UNITED KINGDOM

GLYCERIN BP ORAL SOLUTION ORAL SOLUTION 100%V/V LCM LIMITED UNITED KINGDOM

GLYCERIN SUPPOSITORIES BP 1GINFANTS'

SUPPOSITORY 70%W/W THORNTON & ROSS LTD UNITED KINGDOM

GLYCERIN, LEMON, HONEY WITHGLUCOSE LINC

ORAL SOLUTION N/A LCM LTD UNITED KINGDOM

EL576 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

GLYCERINE SUPP. B.P.2GMOULD-CHILDREN'S

SUPPOSITORY 70%W/W THORNTON & ROSS LTD UNITED KINGDOM

GLYCERINE SUPPOSITORIES BP SUPPOSITORY 70%W/W MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

GLYCERINE SUPPOSITORIES BP 4GADULT SIZE

SUPPOSITORY 70%W/W LCM LTD UNITED KINGDOM

GLYCERYL TRINITRATE BP TABLET 500MCG A.H. COX & COMPANYLIMITED

UNITED KINGDOM

GLYCOMIN TABLET 5MG PHARMACARE LIMITED— SOUTH AFRICA

SOUTH AFRICA

GLYFORMIN TABLETS 500MG REMEDICA LTD. CYPRUS

GLYTRIN SPRAY SUBLIGUAL SPRAYSOLUTION

400 UG/AC BIOGLANLABORATORIES LTD

UNITED KINGDOM

GLYVENOL SOFT CAPSULE 400MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

GLYVENOL 400 CAPSULES 400MG NOVARTIS PHARMA NV BELGIUM

GNOSTOCARDIN TABLET 20MG BROS LTD GREECE

GOANNA ARTHRITIS CREAM CREAM TUBE 100MG/G HERRONPHARMACEUTICALS PTYLTD

AUSTRALIA

GOCCE ODONTALGICHE DENTAL SOLUTION 4ML LABORATORIO CHIMICOFARMACEUTICO A.SELLAS.R.L

ITALY

GOLDEN EYE DROPS EYE DROPS 0.1% W/V TYPHARM LIMITED UNITED KINGDOM

GOLDEN EYE OINTMENT 0.15% EYE OINTMENT 0.15% W/W TYPHARM LIMITED UNITED KINGDOM

GOLDEN SEAL COMPOUNDTABLETS

COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GONAL-F SOLUTION FORINJECTION

150 IU SERONO EUROPELIMITED

UNITED KINGDOM

GONAL-F SOLUTION FORINJECTION

150 IU SERONO EUROPELIMITED

UNITED KINGDOM

GONAL-F SOLUTION FORINJECTION

150 IU SERONO EUROPELIMITED

UNITED KINGDOM

GONAL-F SOLUTION FORINJECTION

150 IU SERONO EUROPELIMITED

UNITED KINGDOM

GONAL-F 75 POWDER FOR INJECTION 75 IU/3ML ARES SERONO (EUROPE)LIMITED

UNITED KINGDOM

GONAL-F 75IU INJECTABLE SOLUTION 75IU R-HFSH/ML LABORATOIRES SERONOSA

SWITZERLAND

GONASI HP SOLUTION FORINJECTION

1000 IU A.M.S.A. S.R.L. ITALY

GONASI HP SOLUTION FORINJECTION

5000 IU A.M.S.A. S.R.L. ITALY

GONIF DRY POWDER FORINJECTION

750MG/VIAL KLEVA LIMITED GREECE

GONNE BALM CREAM N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 577

Trade Name Dosage Form Dose MA Holder Country

GRECOTENS GEL. EXT. US. GEL 0.5% GENEPHARM S.A. GREECE

GREGODERM OINTMENT OINTMENT N/A UNIGREG LIMITED UNITED KINGDOM

GRENIS-CIPRO TABLETS 250MG GENEPHARM S.A. GREECE

GRENIS-CIPRO TABLETS 500MG GENEPHARM S.A. GREECE

GRENOVIX TABLETS 30MG GENEPHARM S.A. GREECE

GRENOVIX SYRUP 30MG/5ML GENEPHARM S.A. GREECE

GRETHER'S BLACKCURRANT PASTILLES NA DOETSCH GRETHER AG SWITZERLAND

GRETHER'S BLACKCURRANTSUGARLESS

PASTILLES NS DOETSCH GRETHER AG SWITZERLAND

GRETHER'S REDCURRANT PASTILLES NA DOETSCH GRETHER AG SWITZERLAND

GRETHER'S REDCURRANTSUGARLESS WITH VITC

PASTILLES NA DOETSCH GRETHER AG SWITZERLAND

GRETHER'S SWIISS ALP FRUITSSUGARLESS

PASTILLES NA DOETSCH GRETHER AG SWITZERLAND

GRIPPOSTAD C CAPSULES N/A STADA ARZNEIMITEL AG GERMANY

GRISEOFULVIN TABLETS 125MG PHARMAMED LTD. MALTA

GRISEOFULVIN TABLETS 125MG REMEDICA CYPRUS

GRISOVIN TABLET 125MG COATED TABLET 125MG GLAXO WELLCOME UKLTD T/A GLAXO LABS

UNITED KINGDOM

GRISOVIN TABLETS 500MG COATED TABLET 500MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

GROFENAC EMULSION GEL 10MG/G DR.GROSSMANN AGPHARMACA

SWITZERLAND

GROFENAC AMPOULE 75MG DR.GROSSMANN AGPHARMACA

SWITZERLAND

GROFENAC SUPPOSITORY 100MG DR.GROSSMANN AGPHARMACA

SWITZERLAND

GROFENAC TABLET 50MG DR.GROSSMANN AGPHARMACA

SWITZERLAND

GROFENAC RETARD TABLET 100MG DR.GROSSMANN AGPHARMACA

SWITZERLAND

GROMAZOL SPRAY 10MG DR.GROSSMANN AGPHARMACA

SWITZERLAND

GROMAZOL CREAM 10MG DR.GROSSMANN AGPHARMACA

SWITZERLAND

GUANOR CHESTY COUGHLINCTUS

ORAL SOLUTION N/A ROSEMONTPHARMACEUTICALSLIMITED

UNITED KINGDOM

GUARINA GRANULES 100% W/W NORGINE LIMITED UNITED KINGDOM

GUASTIL CAPSULE 50MG J.URIACH & CIA. S.A. SPAIN

GUASTIL CHILDREN ORAL SUSPENSION 500MG/100ML J.URIACH & CIA. S.A. SPAIN

GUTTALAX ORAL DROPS 0.75G/100ML BOEHRINGER INGELHEIMITALIA S.P.A.

ITALY

EL578 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

GUTTALAX SOFT CAPSULE (PERLA) 1.5MG BOEHRINGER INGELHEIMITALIA S.P.A.

ITALY

GYNERA COATED TABLET N/A SCHERING AG GERMANY

GYNO CANESTEN 1 VAGINAL TABLET 0.5G BAYER VITAL GMBH &CO. KG

GERMANY

GYNO CANESTEN 6 VAGINAL TABLET 0.1G BAYER VITAL GMBH &CO. KG

GERMANY

GYNO-DAKTARIN VAGINAL CAPSULE 400MG JANSSEN-CILAG N.V. BELGIUM

GYNO-DAKTARIN VAGINAL CAPSULE 1200MG JANSSEN-CILAG N.V. BELGIUM

GYNO-DAKTARIN VAGINAL CREAM 20MG/G JANSSEN-CILAG N.V. BELGIUM

GYNO-DAKTARIN CREAM N/A JANSSEN PAKISTAN

GYNODEL TABLETS 2.5MG IL-KO ILAC VE KOZMETIKSAN.TIC.A.S

TURKEY

GYNODEL TABLET 2.5MG IL-KO ILAC VE KOZMETIKSAN.A.S.

TURKEY

GYNO-PEVARYL VAGINAL CREAM 10MG/G JANSSEN-CILAG AG SWITZERLAND

GYNO-PEVARYL VAGINAL CREAM 1G/100G JANSSEN-CILAG NV BELGIUM

GYNO-PEVARYL 150MG VAGINAL OVULE 150MG JANSSEN-CILAG AG SWITZERLAND

GYNO-PEVARYL DEPOT VAGINAL OVULE 150MG JANSSEN-CILAG AG SWITZERLAND

GYNO-TRAVOGEN OVULA PESSARY 600MG SCHERING SPA ITALY

GYNO-TRAVOGEN OVULUM OVULUM FOR VAGINALUSE

0.6G SCHERING AG GERMANY

GYRABLOCK 400MG TABLET 400MG MEDOCHEMIE LTD CYPRUS

HAEMOCORTIN OINTMENT N/A G.STREULI & CO. AG SWITZERLAND

HAEMOCTIN SDH 1000 FRZ.DRD. SUBS.+DILUENT

N/A BIOTEST PHARMA GMBH GERMANY

HAEMOCTIN SDH 250 FRZ. DRD. SUBS. & DIL. N/A BIOTEST PHARMA GMBH GERMANY

HAEMOCTIN SDH 500 FRZ. DRD. SUBS+DIL. N/A BIOTEST PHARMA GMBH GERMANY

HAEMOLAN OINTMENT N/A G.STREULI & CO. AG SWITZERLAND

HAIRGROW SOLUTION N/A DAR AL DAWADEVELOPMENT ANDINVESTMENT CO.LIMITED

JORDAN

HAIRSCIENCE ANTI-DANDRUFFTREATMENT

SHAMPOO 20MG/G EGO PHARMACEUTICALS AUSTRALIA

HALCION TABLETS 0.125MG PHARMACIA N.V. / S.A. BELGIUM

HALCION TABLETS 0.25MG PHARMACIA N.V. / S.A. BELGIUM

HALDOL 0.5MG TABLET 0.5MG JANSSEN-CILAG N.V. BELGIUM

HALDOL 5MG TABLET 5MG JANSSEN-CILAG N.V. BELGIUM

HALDOL 5MG/ML AMPOULES INJECTABLE SOLUTION 5MG/ML JANSSEN-CILAG N.V. BELGIUM

HALDOL DECANOAS 100MG/ML SOLUTION FORINJECTION

100MG/ML JANSSEN-CILAG N.V. BELGIUM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 579

Trade Name Dosage Form Dose MA Holder Country

HALDOL DECANOAS 50MG/ML SOLUTION FORINJECTION

50MG/ML JANSSEN-CILAG N.V. BELGIUM

HALDOL DROPS DROPS 2MG/ML JANSSEN-CILAG N.V. BELGIUM

HALFAN 100MG/5ML ORAL SOLUTION 100MG/5ML LABORATOIRES SMITHKLINE & BEECHAM

FRANCE

HALFAN 250MG TABLET 250MG LABORATOIRES SMITHKLINE & BEECHAM

FRANCE

HALLS MENTHOLYPTUSBLACKCURRANT

LOZENGE NA WARNER LAMBERT UKLIMITED T/A ADAMS

UNITED KINGDOM

HALLS MENTHOLYPTUS EXTRASTRONG

LOZENGE NA WARNER LAMBERT UKLIMITED T/A ADAMS

UNITED KINGDOM

HALLS MENTHOLYPTUS HONEYAND LEMON

LOZENGE NA WARNER LAMBERT UKLIMITED T/A ADAMS

UNITED KINGDOM

HALLS MENTHOLYPTUSORIGINAL

LOZENGE NA WARNER LAMBERT UKLIMITED T/A ADAMS

UNITED KINGDOM

HALLS MENTHOLYPTUSORIGINAL S/F

LOZENGE NA WARNER LAMBERT UKLIMITED T/A ADAMS

UNITED KINGDOM

HALOPER TABLETS 0.5MG CTS CHEMICALINDUSTRIES LTD.

ISRAEL

HALOPER 0.5MG TABLETS TABLET 0.5MG CTS CHEMICALINDUSTRIES LTD

ISRAEL

HALOPERIDOL TABLETS 1.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

HALOPERIDOL TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

HALOPERIDOL TABLETS 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

HALOPERIDOL TABLETS 20MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

HALOPERIDOL ORAL SOLUTIONBP

ORAL SOLUTION 10MG/5ML ROSEMONTPHARMACEUTICALS LTD.

UNITED KINGDOM

HALOPERIDOL ORAL SOLUTIONBP 10MG/5ML

ORAL SOLUTION 10MG/5ML ROSEMONTPHARMACEUTICALSLIMITED

UNITED KINGDOM

HAMAMELIS WATER B.P.C.(DIST.WITCH HAZEL

TOPICAL SOLUTION 20.7% V/V WILLIAM RANSOM &SON PLC

UNITED KINGDOM

HAPPINOSE OINTMENT 0.3%W/W DIOMED DEVELOPMENTSLIMITED T/A DERMALLABORATORIES

UNITED KINGDOM

HAVRIX 1440 SUSPENSION FORINJECTION

1440 ELISA U/ML SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

HAVRIX JUNIOR 720 SUSPENSION FORINJECTION

720 ELU/0.5ML SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

HAVRIX VACCINE (JUNIOR 360) SUSPENSION FORINJECTION

360 ELISA UNITS SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

HAY-CROM AQUEOUS EYE DROPS 2%W/V NORTON HEALTHCARELIMITED

UNITED KINGDOM

HAY-CROM HAYFEVER EYE DROPS 2% W/V NORTON HEALTHCARELIMITED

UNITED KINGDOM

EL580 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HAYMINE MODIFIED RELEASETABLETS

N/A PHARMAX LIMITED UNITED KINGDOM

HB-VAX DNA 10MCG VACCINE SUSPENSION FORINJECTION

10MCG MERCK SHARP & DOHMEB.V.

NETHERLANDS

HB-VAX DNA 5MCG VACCINE SUSPENSION FORINJECTION

5MCG MERCK SHARP & DOHMEB.V.

NETHERLANDS

HC45 HYDROCORTISONE CREAM CREAM 1%W/W CROOKES HEALTHCARELIMITED

UNITED KINGDOM

HEALIT SKIN OINTMENT OINTMENT NA ATCO LABORATORIES(PVT) LTD

PAKISTAN

HEALTHY FEET CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

HEEMEX OINTMENT N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

HEMATOCIS KIT POWDER FOR INJECTION N/A CIS BIO INTERNATIONAL FRANCE

HEMAX 1000 I.U. FREEZE DRIED PWR FORINJ

1000 I.U. INSTITUTO SIDUS S.A ARGENTINA

HEMAX 10000 IU FREEZE DRIED PWR FORINJ

10000 IU INSTITUTO SIDUS S.A ARGENTINA

HEMAX 2000 I.U FREEZE DRIED PWR FORINJ

2000 IU INSTITUTO SIDUS S.A ARGENTINA

HEMAX 3000 I.U FREEZE DRIED PWR FORINJ

3000 IU INSTITUTO SIDUS S.A ARGENTINA

HEMAX 4000 IU FREEZE DRIED PWR FORINJ

4000 IU INSTITUTO SIDUS S.A. ARGENTINA

HEMI-DAONIL 2.5MG TABLET 2.5MG LABORATOIRESHOECHST

FRANCE

HEMINEVRIN CAPSULES 300MG ASTRA LAKEMEDEL AB SWEDEN

HEMOCANE CREAM RECTAL CREAM N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

HEMOCANE RECTAL CREAM RECTAL CREAM N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

HEMOFIL M - AHF MONOCLONALPURIFIED NOM.

POWDER FOR INJECTION 500IU/VIAL BAXTER HEALTHCARELIMITED

UNITED KINGDOM

HEMOFIL M AHF (HUMAN) — SEEREMARKS

POWDER FOR INJECTION 1000 IU BAXTER HEALTHCARELTD

UNITED KINGDOM

HEMOFIL M AHF MONOCLONALPURIFIED

POWDER FOR INJECTION 250IU/BOTTLE BAXTER HEALTHCARELIMITED

UNITED KINGDOM

HEPA-MERZ GRANULES 3 G MERZ+CO. GMBH & CO. GERMANY

HEPA-MERZ INFUSIONCONCENTRATE

5.0 G MERZ+CO. GMBH & CO. GERMANY

HEPAPLUS 30 EMGEL GEL 30000IU/100G HEXAL AG GERMANY

HEPARIN SOLUTION FORINJECTION

100IU/ML LEO PHARMACEUTICALPRODUCTS

UNITED KINGDOM

HEPARIN «LEO» SOLUTION FORINJECTION

5,000IU/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 581

Trade Name Dosage Form Dose MA Holder Country

HEPARIN CALCIUM INJECTION5000 IU/0.5ML

INECTION SOLUTION 5000 IU/0.5ML B.BRAUN MELSUNGENAG

GERMANY

HEPARIN INJECTION BP5,000UNITS/ML

SOLUTION FORINJECTION

5000UNITS/ML ROTEXMEDICA GMBH,ARZNEIMITTELWERK

GERMANY

HEPARIN SODIUM 100IU/ML AMPOULE SOLN F/INFUSION

1000IU/ML LEO LABORATORIES LTD UNITED KINGDOM

HEPARIN SODIUM 2000U/L IN0.9% SOD. CHL.

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

HEPARIN SODIUM BP 1000IU/L IN0.9% NACL

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

HEPARIN SODIUM BP 1000U/L IN0.9% NACL

SOL. FOR INJ NA BAXTER HEALTHCARELTD

UNITED KINGDOM

HEPARIN SODIUM INJECTION5000 IU/ML

INJECTION SOLUTION 5000 IU/ML B.BRAUN MELSUNGENAG

GERMANY

HEPARIN SODIUM INJECTION5000IU/0.2ML

INJECTION SOLUTION 5000IU/0.2ML B.BRAUN MELSUNGENAG

GERMANY

HEPARIN SODIUM INJECTION USP SOLUTION FORINJECTION

5000 USP U/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

HEPARIN SODIUM IV FLUSHSOLN.

SOLUTION FORINJECTION

10IU/ML LEO LABORATORIES LTD UNITED KINGDOM

HEPARINISED SALINE, 50IU IN5ML

SOLUTION FORINJECTION

10IU/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

HEPARINOL-5000 (5MI) SOLUTION FORINJECTION

5000IU/ML AIN MEDICARE SDN.BHD.

MALAYSIA

HEPATECT SOL. FOR IV INJ. N/A BIOTEST PHARMA GMBH GERMANY

HEPAVAX-GENE POWDER FOR INJ 20UG GREEN CROSS VACCINECORP.

KOREA (DEM PEOPLE'SREP)

HEPAVAX-GENE 20MCG LIQUID FOR INJECTION N/A KOREA GREEN CROSSCORP.,

KOREA REPUBLIC

HEP-FLUSH SOLUTION N/A LEO LABORATORIESLIMITED

UNITED KINGDOM

HEP-FLUSH INJECTION SOLUTION FORINJECTION

100IU/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

HEPLOK FORMERLY HEPARINMUCOUS INJECTION

SOLUTION FORINJECTIONS

10 UNITS/ML LEO LABORATORIESLIMITED

UNITED KINGDOM

HEPSAL SOLUTION FORINJECTION

50IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

HEPSAL INJECTION 10IU/ML SOLUTION FORINJECTION

10IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

HEPSAL INJECTION 10IU/ML SOLUTION FORINJECTION

10IU/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

HERBALUX COATED TABLET N/A PETER BLACKHEALTHCARE LTD. T/AENGLISH GRAINSHEALTHCARE

UNITED KINGDOM

HERBALUX/GERARD HOUSEHERBALUX

COATED TABLET N/A PETER BLACKHEALTHCARE LIMITED

UNITED KINGDOM

HERECEPTIN POWDER FOR INFUSION 150MG ROCHE REGISTRATIONLTD. — UK (EMEA)

UNITED KINGDOM

EL582 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HERPILEM POWDER FOR INJECTION 250MG LEMERY, S.A. DE C.V. MEXICO

HERRON BABY TEETHING GEL TUBE 87MG/G HERRONPHARMACEUTICALS PTYLTD

AUSTRALIA

HEXEDIN, GENERICON TABLET N/A GENERICON PHARMAGES.M.B.H

GERMANY

HEXIGEL DENTAL GEL 0.5% W/W PARKE DAVIS FRANCE

HHT 4 I.U. FREEZE DRIED PWR FORINJ

4 IU INSTITUTO SIDUS S.A. ARGENTINA

HIBERIX POWDER FOR INJECTION NA GLAXOSMITHKLINEBIOLOGICALS

BELGIUM

HIBERIX (HAEMOPHILUSINFLUENZAE TYPE B)

FREEZE-DRIED VACCINE 10MCG SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

HIBICET HOSPITALCONCENTRATE

TOPICAL SOLUTION N/A ZENECA LIMITED UNITED KINGDOM

HIBICET HOSPITALCONCENTRATE

TOPICAL SOLUTION NA TUBIFOAM LIMITED UNITED KINGDOM

HIBISCRUB TOPICAL SOLUTION 4% W/V ZENECA LIMITED UNITED KINGDOM

HIBISCRUB TOPICAL SOLUTION 4%W/V TUBIFOAM LIMITED UNITED KINGDOM

HIBISOL SOLUTION 0.5% W/V ZENECA LIMITED UNITED KINGDOM

HIBISOL SOLUTION TOPICAL SOLUTION 2.5% V/V ZENECA LIMITED UNITED KINGDOM

HIBISOL SOLUTION TOPICAL SOLUTION 2.5%V/V TUBIFOAM LIMITED UNITED KINGDOM

HIBITANE OBSTETRIC CREAM 1% W/W ZENECA LIMITED UNITED KINGDOM

HIBITANE 5% CONCENTRATE TOPICAL SOLUTION 5%W/V TUBIFOAM LIMITED UNITED KINGDOM

HIBITANE CONCENTRATESOLUTION 5%

TOPICAL SOLUTION 25% V/V ZENECA LIMITED UNITED KINGDOM

HIBITANE OBSTETRIC CREAM CREAM 5% V/ W BIOGLANLABORATORIES LTD

UNITED KINGDOM

HIBTITER SOLUTION FORINJECTION

N/A WYETH PHARMA GMBH GERMANY

HIBTITER SOLUTION FORINJECTION

NA CYANAMID OF GREATBRITAIN LTD

UNITED KINGDOM

HIBTITER SOLUTION FORINJECTION

NA WYETH LEDERLE SPA ITALY

HIBTITER HAEMOPHILUS BCONJUGATE VACCINE

SOLUTION FORINJECTION

N/A CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

HIDRASEC CAPSULE 100MG LABORATOIRESBIOPROJET PHARMA

FRANCE

HIDRASEC 18MG PAEDIATRIC ORAL POWDER 18MG LABORATOIREBIOPROJET PHARMA

FRANCE

HIDRASEC 30MG PAEDIATRIC ORAL POWDER 30MG LABORATOIREBIOPROJET PHARMA

FRANCE

HIDRASEC 6MG PAEDIATRIC ORAL POWDER 6MG LABORATOIREBIOPROJET PHARMA

FRANCE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 583

Trade Name Dosage Form Dose MA Holder Country

HIKMA-HEPARIN 25000 VIALS SOLUTION FORINJECTION

25000IU/ML HIKMAPHARMACEUTICALS

JORDAN

HILL'S BALSAM CHESTY COUGHLIQ F/CHILD.

ORAL LIQUID N/A EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

HILL'S BALSAM CHESTY COUGHLIQUID

ORAL LIQUID 100MG/5ML EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

HIRIDOID GEL GEL 0.3%W / W SANKYO PHARMA UKLIMITED

UNITED KINGDOM

HIRUDOID CREAM 300MG/100G SANKYO PHARMA GMBH GERMANY

HIRUDOID GEL 300MG/100G SANKYO PHARMA GMBH GERMANY

HIRUDOID CREAM CREAM 0.3% W/W SANKYO PHARMA UKLIMITED

UNITED KINGDOM

HISTALIX SYRUP N/A WALLACEMANUFACTURINGCHEMISTS LIMITED

UNITED KINGDOM

HISTASIN TABLET 10MG DELTA HF ICELAND

HISTERGAN CREAM CREAM 2%W/W NORMA CHEMICALSLIMITED

UNITED KINGDOM

HIVOTEX SYRUP 30MG/5ML KLEVA LIMITED GREECE

HOLOXAN POWDER FOR INJECTION 500MG ASTA MEDICA GERMANY

HOLOXAN POWDER FOR INJECTION 1G ASTA MEDICA GERMANY

HOLOXAN POWDER FOR INJECTION 2G ASTA MEDICA GERMANY

HONEY AND LEMON MELTUSFOR DEEP CHESTY COU

ORAL SOLUTION 50 MG CUPAL LIMITED UNITED KINGDOM

HONEY AND MOLASSES MIXTURE ORAL SOLUTION N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

HONVAN TABLETS 120MG ASTA MEDICA GERMANY

HONVAN SOLUTION FORINJECTION

300MG/5ML ASTA MEDICA GERMANY

HORESTYL TABLETS 10MG KLEVA LTD GREECE

HORESTYL SYRUP 5MG/5ML KLEVA LTD. GREECE

HORESTYL TABLETS 10MG KLEVA LIMITED GREECE

HORESTYL SYRUP 5MG/5ML KLEVA LIMITED GREECE

HOT LEMON COLD RELIEFPOWDER

POWDER FOR ORALSOLUTION

N/A SUSSEXPHARMACEUTICALSLIMITED

UNITED KINGDOM

HRI NIGHT TABLETS COATED TABLETS NA JESSUP HEALTH LIMITED UNITED KINGDOM

HRI WATER BALANCE TABLETS COATED TABLETS NA JESSUP HEALTH LIMITED UNITED KINGDOM

HUMALOG CARTRIDGE SOLUTION FORINJECTION

100UNITS/ML ELI LILLY NEDERLANDB.V.

NETHERLANDS

HUMALOG CARTRIDGE SOLUTION FORINJECTION

100UNITS/ML ELI LILLY NEDERLANDB.V.

NETHERLANDS

EL584 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HUMALOG VIALS SOLUTION FORINJECTION

100 UNITS/ML ELI LILLY NEDERLANDB.V.

NETHERLANDS

HUMAN ALBUMIN«OCTAPHARMA» 20%

SOLUTION FORINFUSION

182.4-210MG/ML OCTAPHARMAPHARMAZEUTIKAPRODUKTIONSGES.M.B.H.

AUSTRIA

HUMAN ALBUMIN 20% BIOTEST SOL. FOR I.V. USE 200G/1000ML BIOTEST PHARMA GMBH GERMANY

HUMAN ALBUMIN 20% IMMUNOSOL FOR INJ

SOLUTION FORINJECTION

N/A BAXTER AG AUSTRIA

HUMAN ALBUMIN 5% BIOTEST SOL. FOR INTRAVENOUSUSE

50G/1000ML BIOTEST PHARMA GMBH GERMANY

HUMAN ALBUMIN 5% BIOTESTISOTONIC

ISOT.SOL.FOR IV USE 50G/1000ML BIOTEST PHARMA GMBH GERMANY

HUMAN ALBUMIN 5% IMMUNOSOL FOR INJ

SOLUTION FORINJESTION

N/A BAXTER AG AUSTRIA

HUMAN ANTI-D (RHO)IMMUNOGLOBULIN 15%SOL

SOLUTION FORINJECTION

500IU/VIAL BIOPRODUCTSLABORATORY (BPL)

UNITED KINGDOM

HUMAN HEP BIMMUNOGLOBULIN PROTEIN SOL

SOLUTION FORINJECTION

15% W/V BPL, BIO PRODUCTSLABORATORY

UNITED KINGDOM

HUMAN HEP BIMMUNOGLOBULIN PROTEIN SOL

SOLUTION FORINJECTION

15% W/V BPL, BIO PRODUCTSLABORATORY

UNITED KINGDOM

HUMAN IMMUNOGLOBULIN«OCTAPHARMA» 5%

SOLUTION FORINFUSION

45.6-52.5MG/ML OCTAPHARMAPHARMAZEUTIKAPRODUKTIONSGES.M.B.H

AUSTRIA

HUMAN RABIESIMMUNOGLOBULIN FOR IM INJ

SOLUTION FORINJECTION

15% W/V BPL, BIO PRODUCTSLABORATORY

UNITED KINGDOM

HUMAN TETANUS IMMUNOGLO.PROTEIN SOLUT.

SOLUTION FORINJECTION

15%V/W BIOPRODUCTSLABORATORY (BPL)

UNITED KINGDOM

HUMATROPE POWDER FOR INJECTION 4IU(1.33MG)/2ML LABORATOIRES LILLYFRANCE

FRANCE

HUMATROPE POWDER FOR INJECTION 18IU(6MG)/3ML LABORATOIRES LILLYFRANCE

FRANCE

HUMATROPE POWDER FOR INJECTION 16IU(5.3MG)/8ML LABORATOIRES LILLYFRANCE

FRANCE

HUMATROPE POWDER FOR INJECTION 36IU(12MG)/3ML LABORATOIRES LILLYFRANCE

FRANCE

HUMATROPE POWDER FOR INJECTION 72IU(24MG)/3ML LABORATOIRES LILLYFRANCE

FRANCE

HUMEX FOURNIER INHALER N/A URGO SA FRANCE

HUMULIN 70/30 SUSPEN. FOR SC/IMINJECT.

300IU/3ML LILLY FRANCE S.A. FRANCE

HUMULIN 70/30 (30% RAPIDACTING 70% NPH)

SUSPENSION FORINJECTION

100IU/ML LILLY DEUTSCHLANDGMBH

GERMANY

HUMULIN L (HUMULIN INSULINLONG ACTING)

SUSPENSION FORINJECTION

100IU/ML LILLY DEUTSCHLANDGMBH

GERMANY

HUMULIN N (HUMAN INSULINNPH)

SUSPENSION FORINJECTION

100IU/ML LILLY DEUTSCHLANDGMBH

GERMANY

HUMULIN NPH SUSPEN. FOR SC/IMINJEC.

300IU/3ML LILLY FRANCE S.A. FRANCE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 585

Trade Name Dosage Form Dose MA Holder Country

HUMULIN R SOLUTION FOR SC/IMINJEC.

300IU/3ML LILLY FRANCE S.A. FRANCE

HUMULIN R (HUMAN INSULINRAPID ACTING)

LIQUID FOR INJECTION 100IU/ML LILLY DEUTSCHLANDGMBH

GERMANY

HUMULIN U (HUMAN INSULINULTRA LONG ACT)

SUSPENSION FORINJECTION

100IU/ML LILLY DEUTSCHLANDGMBH

GERMANY

HYALASE DRIED POWDER FOR INJ. 1500IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

HYALASE (HYALURONIDASE FORINJECTION BP)

POWDER FOR INJECTION 1500IU/AMPOULE CP PHARMACEUTICALSLTD

UNITED KINGDOM

HYALGAN SOLUTION FORINJECTION

20MG/ML FIDIA SPA ITALY

HYALGAN SOLUTION FORINJECTION

10MG/ML FIDIA SPA ITALY UNITED KINGDOM

HYCAMTIN FOR INJECTION POWDER FOR INJECTION 4MG SMITHKLINE BEECHAMPHARMACEUTICALS

UNITED STATES OFAMERICA

HYCROCORTISONE TABLET 10MG REKAHPHARMACEUTICALINDUSTRY LTD

ISRAEL

HYDERGIN ORAL DROPS (SOL.) 1MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

HYDERM CREAM 1% W/W CREAM 1% W/W TAROPHARMACEUTICALS INC.

CANADA

HYDRACORT CREAM 0.5% W/W LABORATOIRESGALDERMA

FRANCE

HYDRALAZINE TABLETS 25MG REMEDICA LTD. CYPRUS

HYDRALAZINE TABLET 25MG GENERICS (UK) LIMITED— UK

UNITED KINGDOM

HYDREA CAPSULES 500MG BRISTOL MYERS SQUIBB ITALY

HYDREX SURGICALSCRUB-CHLORHEXIDINE

TOPICAL SOLUTION 4% W/V ADAMS HEALTHCARELIMITED

UNITED KINGDOM

HYDROCORTISONE CREAM 1% HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

HYDROCORTISONE CREAM 1%W/W CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

HYDROCORTISONE 1% OINTMENT 1% W/W BIOREX LABORATORIESLTD.

UNITED KINGDOM

HYDROCORTISONE 1% B.P. CREAM 1% W/W BIOREX LABORATORIESLTD.

UNITED KINGDOM

HYDROCORTISONE CREAM CREAM 1% W/V NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

HYDROCORTISONE CREAM 1%OTC

CREAM 1% W/V NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

HYDROCORTISONE CREAM 1%W/W

CREAM 1% W/W CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

HYDROCORTISONE CREAM B.P1%

CREAM 1% W / W BIOREX LABORATORIESLTD

UNITED KINGDOM

EL586 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HYDROCORTISONE EYEOINTMENT BPC 1%

EYE OINTMENT 1%W/W MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

HYDROCORTISONE/HYDRODERM OINTMENT 10MG/G SCHERING-PLOUGH S.A. BELGIUM

HYDROCORTISONE-MEDO100MG

POWDER FOR INJECTION 100MG MEDOCHEMIE LTD CYPRUS

HYDROCORTISYL SKIN CREAM CREAM 1% W/W ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

HYDROCORTISYL SKINOINTMENT

OINTMENT 1% W/W ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

HYDROGEN PEROXIDE TOPICAL SOLUTION 6%V/V LCM LTD UNITED KINGDOM

HYDROGEN PEROXIDE SOLUTION SOLUTION 6%BP 20 VOLS LCM LIMITED UNITED KINGDOM

HYDROGEN PEROXIDE SOLUTION TOPICAL SOLUTION 9% 30 VOLS LCM LTD UNITED KINGDOM

HYDROGEN PEROXIDE SOLUTION9% 30 VOLS

TOPICAL SOLUTION 9%V/V LCM LTD UNITED KINGDOM

HYDROMOL CREAM CREAM N/A QUINODERM LIMITED UNITED KINGDOM

HYDROXOCOBALAMIN INJECTION BP 1MG ROTEXMEDICA GMBH,ARZNEIMITTELWERK -GERMANY

GERMANY

HYDROXOCOBALAMININJECTION

SOLUTION FORINJECTION

1MG/1ML GOLDSHIELD GROUP PLC UNITED KINGDOM

HYGROTON TABLETS 50MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

HYOSCINE BUTYLBROMIDE FILM-COATED TABLETS 10MG PHARMAMED LTD. MALTA

HYOSCINE BUTYLBROMIDE FILM-COATED TABLETS 20MG PHARMAMED LTD. MALTA

HYOSCINE BUTYLBROMIDEINJECTION

SOLUTION FORINJECTION

20MG/1ML ROTEXMEDICA GMBH GERMANY

HYOSCINE INJECTION BP SOLUTION FORINJECTION

400MCG/1ML EVANS MEDICAL LIMITED UNITED KINGDOM

HYPERIUM 1MG TABLET 1MG LES LABORATOIRESSERVIER

FRANCE

HYPNOMIDATE 10ML AMPOULE 2MG/ML JANSSEN-CILAG N.V. BELGIUM

HYPOVASE TABLET N/A PFIZER LIMITED UNITED KINGDOM

HYPOVASE TABLET 500MCG PFIZER LIMITED UNITED KINGDOM

HYPOVASE TABLETS 1MG PFIZER LIMITED UNITED KINGDOM

HYPOVASE TABLET 5MG PFIZER LIMITED UNITED KINGDOM

HYPOVASE TABLET 2MG PFIZER LIMITED UNITED KINGDOM

HYPRIN BOVINE ISOPHANE SUSPENSION FORINJECTION

100IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

HYPROMELLOSE EYE DROPS BPC0.3%

EYE DROPS 0.3%W/V MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

HYPURIN BOVINE LENTE SUSPENSION FORINJECTION

100IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

HYPURIN BOVINE NEUTRAL SOLUTION FORINJECTION

100IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 587

Trade Name Dosage Form Dose MA Holder Country

HYPURIN BOVINE PROTAMINEZINC

SUSPENSION FORINJECTION

100IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

HYPURIN PORCIN NEUTRAL SOLUTION FORINJECTION

100IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

HYPURIN PORCINE BIPHASICISOPHANE

SUSPENSION FORINJECTION

N/A CP PHARMACEUTICALSLTD.

UNITED KINGDOM

HYPURIN PORCINE ISOPHANE SUSPENSION FORINJECTION

100IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

HYTRIN 1MG TABLETS 1MG ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

HYTRIN 2MG TABLETS 2MG ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

HYTRIN 5MG TABLETS 5MG ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

HYTRIN BPH 10MG TABLETS 10MG ABBOTT LABORATORIESLTD.

UNITED KINGDOM

HYTRIN BPH 1MG STARTER KIT TABLETS 1MG ABBOTT LABORATORIESLTD.

UNITED KINGDOM

HYTRIN BPH 2MG TABLETS 2MG ABBOTT LABORATORIESLTD

UNITED KINGDOM

HYTRIN BPH 5MG TABLETS 5MG ABBOTT LABORATORIESLTD.

UNITED KINGDOM

HYZAAR 50/12.5MG TABLET N/A MERCK SHARP & DOHMEB.V.

NETHERLANDS

IBUFEN TABLET 200 MG DELTA HF ICELAND

IBUFEN TABLET 400MG DELTA HF ICELAND

IBUFEN TABLET 600MG DELTA HF ICELAND

IBUGESIC 200 FILM COATED TABLETS 200MG DAR AL DAWA DEV. &INV. CO. LTD.

JORDAN

IBUGESIC-200 TABLET 200MG CIPLA LIMITED INDIA

IBUHEXAL 200 FILM COATED TABLET 200MG HEXAL AG GERMANY

IBUKOD TABLETS N/A DELTA HF ICELAND

IBUKOD STERKAR TABLETS TABLET N/A DELTA HF ICELAND

IBULEVE/IBULEVE SPORTGEL5%W/W / IBUDERM

GEL 5% W/W DIOMED DEVELOPMENTSLIMITED T/A DERMALLABORATORIES

UNITED KINGDOM

IBUPROFEN TABLETS 200MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

IBUPROFEN TABLETS 400MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

IBUPROFEN COATED TABLETS 200MG PHARMAMED LTD. MALTA

IBUPROFEN TABLETS 400MG PHARMAMED LTD. MALTA

IBUPROFEN 200MG COATED TABLETS 200MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

EL588 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

IBUPROFEN 400MG COATED TABLET 400MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

IBUPROFEN 5% GEL GEL 5% W/W GOLDSHIELDPHARMACEUTICALS LTD

UNITED KINGDOM

IBUPROFEN BP 200MG TABLET 200MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

IBUPROFEN BP 400MG TABLET 400MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

IBUPROFEN BP 600MG TABLET 600MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

IBUPROFEN DENK 400 FILM COATED TABLET 400MG E.DENK OHG GERMANY

IBUPROFEN TABLETS COATED TABLETS 200MG HEALTHY IDEAS LIMITED UNITED KINGDOM

IBUPROFEN TABLETS BP 200 MG TABLET 200 MG CIPLA LTD INDIA

IBUSPAN TABLETS 200MG SM PHARMACEUTICALSSDN. BHD.

MALAYSIA

IBUTOP CUPROFEN IBUPROFENGEL

GEL 5% W/W SETON PRODUCTSLIMITED

UNITED KINGDOM

IBUTOP GEL GEL 5G/100G DOLORGIET GMBH & CO.KG

GERMANY

ICTHTAMMOL OINTMENT BP1980

OINTMENT 10%W/W THORNTON & ROSS LTD UNITED KINGDOM

IDEOS CHEWABLE TABLET N/A LABORATOIREINNOTHERA

FRANCE

IDRACEMI OPHTHALMIC DROPS 0.335G FARMIGEA SPA ITALY

IDRACEMI OPHTHALMIC OINTMENT N/A 014438 030 ITALY

IDUCHER OPHTHALMIC DROPS 0.2G FARMIGEA SPA ITALY

IDUCHER OPHTHALMIC OINTMENT 0.2G/100G FARMIGEA SPA ITALY

IETAPAR CAPSULE N/A ROTTAPHARM S.R.L ITALY

IETEPAR INJECTABLE IM SOLN. N/A ROTTAPHARM SRL ITALY

IFICIPRO SOL. FOR INJECTION 200MG IFIUNIKPHARMACEUTICALSLIMITED

INDIA

IFICIPRO — CIPROFLOXACININJECTION 200MG

SOLUTION FORINJECTION

200MG (2MG/ML) UNIQUEPHARMACEUTICALLABORATORIES

INDIA

IKOREL TABLETS 10MG MAY & BAKER LIMITED UNITED KINGDOM

ILOMEDIN SOLUTION FOR IVINFUSION

0.05MG/0.5ML SCHERING AG GERMANY

ILOSONE 125MG/5ML SUSPENSION 125MG/5ML DISTA S.A. SPAIN

ILOSONE 500MG COATED TABLET 500MG LILLY, S.A. SPAIN

IMDUR PROLONGED RELEASETABLETS

60MG HASSLE LAKEMEDEL AB SWEDEN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 589

Trade Name Dosage Form Dose MA Holder Country

IMIGRAN COATED TABLETS 50MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

IMIGRAN 100MG FILM COATED TABLETS 100MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

IMIGRAN INJECTION SOLUTION FORINJECTION

12MG/ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

IMIGRAN TABLETS 100MG FILM COATED TABLET 100MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

IMIGRAN TABLETS 50MG TABLET 50MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

IMIPRAMINE BP 10MG TABLET 10MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

IMIPRAMINE BP 25MG TABLET 25MG SUSSEXPHARMACEUITICALLIMITED

UNITED KINGDOM

IMMUBRON TABLET 50MG BRUSCHETTINI SRL ITALY

IMMUCYST — PWS-LIQ ITV PRCLIQUID

POWDER FOR SOLUTION 27MG/ML CONNAUGHTLABORATORIES LIMITED

CANADA

IMMUCYST -PWS LIQ ITV PRCLIQUID

POWDER FOR SOLUTION 81MG/3ML CONNAUGHTLABORATORIES LTD

CANADA

IMMULEM SOLUTION 5G/50ML LEMERY S.A MEXICO

IMMUNATE 1000 I.E POWDER FOR INJECTION N/A BAXTER AG AUSTRIA

IMMUNATE 250 I.E POWDER FOR INJECTION N/A BAXTER AG AUSTRIA

IMMUNATE 500 I.E POWDER FOR INJECTION N/A BAXTER AG AUSTRIA

IMMUNOGLOBULINE I.V. (NRM.I.V. IMMUNOG)

PWD. FOR SOL. FOR. INF. N/A CLB NETHERLANDS

IMMUNOVIR CREAM 5%W/W FARMA UNO SRL ITALY

IMOCAP CAPSULE 2MG RAZA MANUFACTURINGBERHAD

MALAYSIA

IMODIUM CAPSULE 2MG JANSSEN-CILAG N.V. BELGIUM

IMODIUM CAPSULE 2MG JANSSEN PAKISTAN

IMODIUM CAPSULE 2MG JANSSEN PAKISTAN

IMOGRAM RAGE 150UI/ML INJECTABLE SOLUTION 150IU/1ML PASTEUR MERIEXSERUMS ET VACCINS

FRANCE

IMOVAX POLIO INJECTABLE SOLUTION N/A PASTEUR MERIEUXCONNAUGHT

FRANCE

IMOX(AMOXICILLIN CAPSULES BP) CAPSULE 250MG IPCA LABORATORIESLIMITED

INDIA

IMPLANON IMPLANT (SUB-DERMALUSE)

68MG ORGANONLABORATORIES LIMITED

UNITED KINGDOM

IMPORTAL ORAL POWDER INSACHETS

10G NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

IMUPRIN TABLETS 50MG REMEDICA LTD. CYPRUS

EL590 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

IMURAN TABLETS 50MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

IMURAN FILM COATED TABLETS 25MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

IMURAN COATED TABLETS 50MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

IMURAN FILM-COATED TABLETS 25MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

INAPROL TABLETS 250MG BILIM ILAC SANAYII VETICARET A.S.

TURKEY

INCIDAL TABLET N/A BAYER PAKISTAN

INDERAL COATED TABLET 10MG ZENECA LIMITED UNITED KINGDOM

INDERAL COATED TABLET 40MG ZENECA LIMITED UNITED KINGDOM

INDERAL INJECTION SOLUTION FORINJECTION

0.1% W/V ZENECA LIMITED UNITED KINGDOM

INDERAL LA MODIFIED RELEASECAPSULES

160MG ZENECA LIMITED UNITED KINGDOM

INDERAL LA-80 CAPSULE 80MG ZENECA LIMITED UNITED KINGDOM

INDOCEM 25 CAPSULES 25MG AEGIS LTD. CYPRUS

INDOCID 100MG SUPPOSITORY 100MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

INDOCID 25MG CAPSULE 25MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

INDOCID RETARD 75MG CAPSULE 75MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

INDOGESIC SUPPOSITORIES 100MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

INDOGESIC 25 CAPSULE 25MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

INDOLGINA CAPSULE 25MG J.URIACH & CIA. S.A. SPAIN

INDOLGINA SUPPOSITORY 100MG J.URIACH & CIA. S.A. SPAIN

INDOMELAN CAPSULE 25MG LANNACHER HEILMITTELGMBH.

AUSTRIA

INDOMELAN SUPPOSITORY 100MG LANNACHER HEILMITTELGMBH.

AUSTRIA

INDOMETHACIN SUPPOSITORIES 100MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

INDOMETHACIN BP 25MG CAPSULE 25MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

INDOMETHACIN BP 50MG CAPSULE 50MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

INDOMETHACIN CAPSULES BP CAPSULE 25MG IPCA LABORATORIESLIMITED

INDIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 591

Trade Name Dosage Form Dose MA Holder Country

INDOPREX EYE DROPS SOLUTION 2% DEMO S.A GREECE

INDOREM 25 TABLETS 25MG REMEDICA LTD CYPRUS

INDYLON 100MG SUPPOSITORIES 100MG MEDOCHEMIE LTD CYPRUS

INDYLON 25MG CAPSULE 25MG MEDOCHEMIE LTD CYPRUS

INFACOL ORAL LIQUID 4% W/V PHARMAX LIMITED UNITED KINGDOM

INFANRIX SUSPENSION FORINJECTION

N/A SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

INFANRIX HEPB SUSPENSION FORINJECTION

N/A SMITHKLINE BEECHAMBIOLOGICALS S.A.

BELGIUM

INFANRIX HEXA SEE REMARKS NA SMITHKLINE BEECHAMBIOLOGICALS S.A.

EUROPEAN COMMUNITY

INFANRIX IPV (DTPA-IPV) SUSPENSION FORINJECTION

SEE REMARKS GLAXOSMITHKLINEBIOLOGICALS S.A.

BELGIUM

INFANRIX IPV+HIB SUSPENSION FORINJECTION

N/A SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

INFANRIX-HIB SUSPENSION FORINJECTION

N/A SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

INFECTOFLAM EYE OINTMENT N/A CIBA VISION AG SWITZERLAND

INFECTOFLAM EYE DROPS N/A CIBA VISION AG SWITZERLAND

INFECTOFLAM EYE OINTMENT NA NOVARTISOPHTHALMICS AG

SWITZERLAND

INFECTOFLAM EYE DROPS NA NOVARTIS OPHTHAMICSAG

SWITZERLAND

INFED (IRON DEXTRANINJECTION USP)

SOLN F/IM IV USE 50MG/ML SCHEINPHARMACEUTICAL INC.

UNITED STATES OFAMERICA

INFLEXAL BERNA V SUSPENSION FORINJECTION

N/A ISTITUTOSIEROTERAPICO BERNAS.R.L.

ITALY

INFLORAN BERNA CAPSULES N/A SWISS SERUM ANDVACCINE INSTITUTEBERNE

SWITZERLAND

INFLUVAC 2000/2001 SUSPENSION FORINJECTION

15MCG/0.5ML SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

INFLUVAC 2001/2002 SUSPENSION FORINJECTION

15 MCG/0.5 SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

INFLUVAC 2002/2003 SUSPENSION FORINJECTION

15MCG/ML SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

INHALANT CAPSULES INHALATION LIQUID N/A INDUSTRIALPHARMACEUTICALSERVICE LIMITED

UNITED KINGDOM

INNOHEP SOLUTION FORINJECTION

3500IU/0.35ML LEO PHARMACEUTICALPRODUCTS

DENMARK

INNOHEP SOLUTION FORINJECTION

4500IU/0.45ML LEO PHARMACEUTICALPRODUCTS

DENMARK

INNOHEP SOLUTION FORINJECTION

10,000IU/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

EL592 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

INNOHEP SOLUTION FORINJECTION

20,000IU/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

INNOHEP SOLUTION FORINJECTION

20000IU/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

INNOHEP SOLUTION FORINJECTION

2,500 IU/0.25ML LEO PHARMACEUTICALPRODUCTS

DENMARK

INNOHEP 10,000IU/ML SOLUTION FORINJECTION

10,000IU/ML LEO LABORATORIES LTD DENMARK

INNOHEP 20,000IU/ML SOLUTION FORINJECTION

20,000IU/ML LEO LABORATORIES LTD UNITED KINGDOM

INNOHEP SYRINGE 10,000IU/ML SOLUTION FORINJECTION

10,000IU/ML LEO LABORATORIES LTD UNITED KINGDOM

INNOHEP SYRINGE 20,000IU/ML SOLUTION FORINJECTION

20,000IU/ML LEO LABORATORIES LTD DENMARK

INPANOL TABLETS 10MG TABLET 10MG DRUG HOUSES OFAUSTRALIA(ASIA) PTELTD

SINGAPORE

INSTILLAGEL GEL N/A FARCO-PHARMA GMBH GERMANY

INSULATARD HM PENFILL100 IU/ML X10ML

SUSPENSION FORINJECTION

100IU/ML NOVO NORDISK A/S DENMARK

INSULATARD HM PENFILL100 IU/ML.1.5ML

SUSPENSION FORINJECTION

NA NOVO NORDISK A/S DENMARK

INTAFEN - 200 TABLETS 200MG INTAS-PHARMACEUTICALS LTD.

INDIA

INTAL 1MG/DOSE INHALER MET. DOSE PRESS.AEROSOL

1MG/ACTUATION FISONS LIMITED T/ARHONE-POULENC RORER

UNITED KINGDOM

INTAL 1MG/DOSE INHALER AEROSOL 1MG/ACTUATION FISONS LTD T/A RHONE-POULENC RORER

UNITED KINGDOM

INTAL INHALER (5MG) MET. DOSE PRESS.AEROSOL

5MG/ACTUATION FISONS LIMITED T/ARHONE-POULENC RORER

UNITED KINGDOM

INTAL INHALER (5MG) AEROSOL 5MG/ACTUATION FISONS LTD T/A RHONE-POULENC RORER

UNITED KINGDOM

INTAL NEBULISER SOL. AMPOULE20MG/2ML

NASAL SPRAY 1% W/V FISONS LIMITED T/ARHONE-POULENC RORER

UNITED KINGDOM

INTAL NEBULISER SOLUTIONAMPOULE

NASAL SPRAY 1%W/V FISONS LTD T/A RHONE-POULENC RORER

UNITED KINGDOM

INTAL SPINCAPS CAPSULES 20MG INHALATION POWDER 20MG FISONS LIMITED T/ARHONE-POULENC RORER

UNITED KINGDOM

INTAL SPINCAPS CAPSULES 20MG 20MG CAPSULE(POWDER) FISONS LTD T/A RHONE-POULENC RORER

UNITED KINGDOM

INTALGIN GEL GEL N/A 3M HEALTH CARELIMITED

UNITED KINGDOM

INTERMOXIL DRY SYRUP 125MG/5ML PT INTERBAT INDONESIA

INTERPRIL 10 TABLETS 10MG PT INTERBAT INDONESIA

INTERPRIL 5 TABLET 5MG PT INTERBAT INDONESIA

INTRAFER LIQUID FOR I.M. USE 100MG/2ML GEYMONAT ITALY

INTRAFER ORAL SOLUTION N/A GEYMONAT SPA ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 593

Trade Name Dosage Form Dose MA Holder Country

INTRAFER ORAL DROPS N/A GEYMONAT SPA ITALY

INTRAGLOBIN F SOL FOR INTRAVENOUSADM.

50MG/ML BIOTEST PHARMA GMBH GERMANY

INTRALIPID 20% EMULSION FORINJECTION

20%W/V FRESENIUS KABI LIMITED UNITED KINGDOM

INTRAMED TRICHAZOLE SOLUTION FORINFUSION

500MG/100ML BODENE (PROPIETARY)LIMITED T/A INTRAMED— SOUTH AFRICA

SOUTH AFRICA

INTRAVEN GV 101 SOLUTION FOR IVINFUSION

0.9% W/V BP GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRAVEN GV 102 SOLUTION FOR IVINFUSION

0.9% W/V BP GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRAVEN GV 112 SOLUTION FORINFUSION

0.45% W/V BP GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRAVEN GV 121 SOLUTION FOR IVINFUSION

5% W/V BP GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRAVEN GV 122 SOLUTION FOR IVINFUSION

5% W/V BP GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRAVEN GV 152 SOLUTION FOR IVINFUSION

N/A GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRAVEN GV 172 SOLUTION FOR IVINFUSION

N/A GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRAVEN GV 202 SOLUTION FOR IVINFUSION

N/A GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRAVEN GV 262 SOLUTION FOR IVINFUSION

N/A IVEX PHARMACEUTICALSLIMITED

UNITED KINGDOM

INTRAVEN GV 352 SOLUTION FOR IVINFUSION

N/A GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRAVEN GV104 SOLUTION FOR IVINFUSION

0.9% W/VBP GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

INTRON A POWDER FOR INJECTION 5×10(6) IU\VIAL SCHERING-PLOUGH LTD. IRELAND

INTRON A POWDER FOR INJECTION 3×10(6)IU/VIAL SCHERING-PLOUGH LTD. IRELAND

INTRON A SOLUTION FORINJECTION

18 MILLION IU SP EUROPE IRELAND

INTRON A SOLUTION FORINJECTION

25 MILLION IU SP EUROPE IRELAND

INTROPIN SOLUTION FORINJECTION

40MG/ML FAULDING HOSPITALPRODUCTS

UNITED STATES OFAMERICA

INVANZ POWD. F/CONC F/SOLNF/INF

1G/VIAL MERCK SHARP & DOHMELIMITED

EUROPEAN COMMUNITY

INVIRASE CAPSULE 200MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

IODINE SOLUTION STRONG BP1958

TOPICAL SOLUTION N/A THORNTON & ROSS LTD UNITED KINGDOM

IODINE TINCTURE BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM

IODIO, ALCOHOLIC CUTANEOUSSOLUTION

ALCOHOLICCUTANEOUS SOL

N/A LABORATORIO CHIMICOFARMACEUTIC A. SELLAS.R.L

ITALY

EL594 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

IOPAMIRO (100ML) SOLUTION FOR IVINFUSION

NA BRACCO S.P.A ITALY

IOPAMIRO (50ML) SOLUTION FOR IVINFUSION

NA BRACCO S.P.A ITALY

IOPIDINE 0.5% OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVREURN.V.

BELGIUM

IPECAVOM SYRUP 1000MG/15ML ELPEN S.A GREECE

IPERTON TABLETS N/A KLEVA LTD GREECE

IPOLIPID 600MG TABLET 600MG MEDOCHEMIE LTD CYPRUS

IPRACIP - 20 INHALER AEROSOL CANISTER 20 MCG M/S. MEDISPRAYLABORATORIES PVT. LTD— GOA

INDIA

IPRAGOCCE OPHTHALMIC SOLUTION NA PROGE FARMA SRL ITALY

IPRATROPIUM STERI-NEB SOLUTION FORNEBULISATION

250MCG/1ML STERIPAK LIMITED UNITED KINGDOM

IPRATROPIUM STERI-NEB500MCG/2ML

SOLUTION FORNEBULISATION

500MCG/2ML STERIPAK LIMTIED UNITED KINGDOM

IPRAVENT INHALER INHALER 20MCG CIPLA LIMITED INDIA

IPRAVENT INHALER INHALER 4MG CIPLA LTD — INDIA INDIA

IPROBEN 200 LACTAB 200MG MEPHA PHARMA AG SWITZERLAND

IRFEN LACTAB 200MG MEPHA PHARMA AG SWITZERLAND

IRONORM CAPSULES N/A WALLACEMANUFACTURINGCHEMISTS LIMITED

UNITED KINGDOM

ISLA-MINT HERBAL LOZENGES 100,00MG ENGELHARDARZNEIMITTEL GMBH &CO. KG

GERMANY

ISLA-MOOS HERBAL LOZENGES LOZENGES 80MG ENGELHARDARZNEIMITTEL GMBH &CO. KG

GERMANY

ISMELIN EYE DROPS 50MG/ML CIBA VISION AG SWITZERLAND

ISMO TABLETS 20MG ROCHE PRODUCTSLIMITED

UNITED KINGDOM

ISMO 20 TABLET 20MG HOFFMANN-LA ROCHEAG

GERMANY

ISMO 20 TABLET 20MG ROCHE PAKISTAN

ISMO 20 TABLET 20MG ROCHE PAKISTANLIMITED

PAKISTAN

ISMONIT 20 TABLET 20MG HEXAL AG GERMANY

ISO MACK RETARD 20MG CAPSULE WITH SUST.ACTION

20MG HEINRICH MACK NACHF GERMANY

ISO MACK RETARD 40MG CAPSULE WITH SUSTRELEASE

40MG HEINRICH MACK NACHF GERMANY

ISO MACK SPRAY SOLUTION 1.25MG/0.09ML HEINRICH MACK NACHF GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 595

Trade Name Dosage Form Dose MA Holder Country

ISOCARD TABLETS 10MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

ISOFLURANE LIQUID FORINHALATION

>99.9% HALOCARBONLABORATORIES

UNITED STATES OFAMERICA

ISOGEL GRANULES FOR ORALSOLN.

90% W/W UNICLIFFE LIMITED T/APFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

ISOKET SOLUTION 0.1% SOLUTION FORINFUSION

0.1% SCHWARZ PHARMA AG GERMANY

ISONIAZID 100MG TABLETS PHARMAMED LTD. MALTA

ISONIAZID TABLETS 300MG PHARMAMED LTD. MALTA

ISOPRENALINE HCL INJECTIONMINIJET

SOLUTION FORINJECTION

20MCG/ML INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

ISOPRENALINE HCL MINIJET SOLUTION FORINJECTION

0.002%W/V INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

ISOPRENALINE INJ MINIJET0.002%W/V

AQUEOUS SOLUTION 20MCG/ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

ISOPRINOSINE TABLET 500MG NEWPORT SYNTHESISLTD.

IRELAND

ISOPRINOSINE SYRUP 250MG/5ML NEWPORT SYNTHESISLTD.

IRELAND

ISOPROTERENOLHYDROCHLORIDE USP.1:5000

SOLUTION FORINJECTION

0.2MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

ISOPTO CARPINE 1% OPHTHALMIC SOLUTION 10MG/ML S.A. ALCON-COUVREURN.V.

BELGIUM

ISOPTO CARPINE 2% OPHTHALMIC SOLUTION 2% W/V S.A. ALCON-COUVREURN.V.

BELGIUM

ISOPTO CARPINE 4% OPHTHALMIC SOLUTION 4% W/V S.A. ALCON-COUVREURN.V.

BELGIUM

ISOPTO FENICOL 0.5% OPHTHALMIC SOLUTION 5MG/ML S.A. ALCON-COUVREURN.V.

BELGIUM

ISOPTO FENICOL0.5%/CHLORAMPHENICOL 0.5%

OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVREURN.V.

BELGIUM

ISORDIL TABLET 10MG WYETH LEDERLE PAKISTAN

ISORDIL TABLET 10MG WYETH-LEDERLE PAKISTAN

ISORDIL TAB 10MG TABLET 10MG WYETH-AYERSTCANADA INC.

CANADA

ISORDIL TAB 5MG SUBLINGUAL TABLET 5MG WYETH-AYERSTCANADA INC.

CANADA

ISOSORBIDE DINITRATE TABLETS 10MG PHARMAX LIMITED UNITED KINGDOM

ISOSORBIDE DINITRATE TABLET 20MG PHARMAX LIMITED UNITED KINGDOM

ISOSORBIDE MONONITRATE TABLETS 10MG PHARMAX LIMITED UNITED KINGDOM

ISOSORBIDE MONONITRATE TABLET 20MG PHARMAX LIMITED UNITED KINGDOM

EL596 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ISOSORBIDE MONONITRATE TABLET 40MG PHARMAX LIMITED UNITED KINGDOM

ISOSORBIDE MONONITRATE TABLETS 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

ISOSORBIDE MONONITRATE TABLETS 20MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

ISOSORBIDE MONONITRATE TABLETS 40MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

ISOTREX GEL GEL 0.05% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

ISOVIST-300 SOLN FOR INJ. ANDORAL USE

640.75MG/ML SCHERING AG GERMANY

ISPAGEL POWDER FOR ORALSUSPENSION

NA RICHMONDPHARMACEUTICALSLIMITED

UNITED KINGDOM

ISTIN TABLET 10MG PFIZER LIMITED UNITED KINGDOM

ISTIN TABLET 5MG PFIZER LIMITED UNITED KINGDOM

ITASPOR CAPSULES 100MG INTASPHARMACEUTICALS LTD

INDIA

ITASPOR (ITRACONAZOLECAPSULES 100MG)

CAPSULE 100MG INTASPHARMACEUTICALS LTD

INDIA

IV-GLOBULIN (1,000MG) POWDER FORRECONSTITUTION

N/A KOREA GREEN CROSSCORP.

KOREA REPUBLIC

IV-GLOBULIN (2,500MG) POWDER FORRECONSTITUTION

N/A KOREA GREEN CROSSCORP.

KOREA REPUBLIC

IXEL CAPSULE 25MG LABORATOIRES PIERREFABRE MEDICAMENT

FRANCE

IXEL CAPSULE 50MG LABORATOIRES PIERREFABRE MEDICAMENT

FRANCE

IXENSE SUBLINGUAL TABLETS 2MG TAKEDA EUROPE R&DCENTRE LIMITED

UNITED KINGDOM

IXENSE SUBLINGUAL TABLETS 3MG TAKEDA EUROPE R&DCENTRE LIMITED

UNITED KINGDOM

JACKSON'S HERBAL LAXATIVE SYRUP N/A ANGLIAN PHARMA PLC UNITED KINGDOM

JECTOFER SOLUTION FORINJECTION

50MG/ML ASTRA LAKEMEDEL AB SWEDEN

JODOPLEX LIQUID SOAP N/A G.STREULI & CO. AG SWITZERLAND

JODOPLEX OINTMENT N/A G.STREULI & CO.AG SWITZERLAND

JODOPLEX SOLUTION 10MG/ML G.STREULI & CO. AG SWITZERLAND

JOINT AND MUSCLE BALSAM OINTMENT N/A AH EHRLICH GMBH & COKG

GERMANY

JOINT AND MUSCLE BALSAM,EHRLICH BALSAM OI

OINTMENT NA AH EHRLICH GMBH &CO. KG

GERMANY

JOY RIDES TABLETS 0.075%W/W STAFFORD MILLERLIMITED

UNITED KINGDOM

JOY-RIDES TABLET 0.075 W/W STAFFORD-MILLERLIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 597

Trade Name Dosage Form Dose MA Holder Country

JUMEX 5MG TABLET 5MG SEARLE PAKISTAN

JUNIFEN SUSPENSION ORAL SUSPENSION 100MG/5ML CROOKES HEALTHCARELIMITED

UNITED KINGDOM

JUNIOR IBUPROFEN SUPENSION ORAL SUSPENSION 100MG/5ML GALPHARMHEALTHCARE LIMITED

UNITED KINGDOM

JUNIOR MELTUS FOR CHESTYCOUGHS AND CATARR

ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM

JUNIOR MELTUS FOR DRI TICKLYCOUGHS AND CA

ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM

JUNIOR MELTUS NIGHT TIME SYRUP N/A CUPAL LIMITED UNITED KINGDOM

JUNIOR MELTUS SUGAR ANDCOLOR FREE EXPECTO

ORAL LIQUID N/A CUPAL LIMITED UNITED KINGDOM

JUNIOR PARAPAEDPARACETAMOL SUSPENSION

ORAL SUSPENSION 120MG/5ML PINEWOODLABORATORIES LIMITEDT/A PINEWOODHEALTHCARE LIMITED

UNITED KINGDOM

KABIKINASE POWDER FOR INFUSION 25000IU/VIAL PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

KABIKINASE POWDER FOR INFUSION 1500000IU/VIAL PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

KALETRA CAPSULES NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

KALETRA ORAL SOLUTION NA ABBOTT LABORATORIESLIMITED

EUROPEAN COMMUNITY

KALETRA SOFT GELATIN CAPSULES NA ABBOTT LABORATORIESLIMITED

EUROPEAN COMMUNITY

KALI SULPH 6X NEW ERABIOCHEMIC NO.7

TISSUE SALT TABLETSNO.7

NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

KALI. MUR. 6X NEW ERABIOCHEMIC NO.5

TISSUE SALT TABLETSNO.5

NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

KALMIREN 10 TABLETS 10MG AEGIS LTD. CYPRUS

KALMIREN 5 TABLETS 5MG AEGIS LTD. CYPRUS

KALMS TABLETS COATED TABLET N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

KALPIREN TABLET 5MG MEDOCHEMIE LTD CYPRUS

KALPIREN 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS

KALTEN CAPSULE N/A ZENECA LIMITED UNITED KINGDOM

KAMAGRA-100 FILM COATED TABLET 100MG AJANTA PHARMA LTD. INDIA

KAMAGRA-50 FILM COATED TABLET 50MG AJANTA PHARMA LTD. INDIA

KAMILLOSAN OINTMENT 10.5%W/W NORGINE LIMITED UNITED KINGDOM

KAMILLOSAN OINTMENT 10.5%W/W GOLDSHIELDPHARMACEUTICALSLIMITED

UNITED KINGDOM

KAMISTAD-GEL GEL N/A STADAPHARM GERMANY

EL598 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

KANAMYCIN-POS EYE DROPS 6.2MG/ML URSAPHARMARZNEIMITTEL GMBH

GERMANY

KANAMYCIN-POS EYE OINTMENT 6.2MG/G URSAPHARMARZNEIMITTEL GMBH

GERMANY

KAOLIN AND MORPHINEMIXTURE BP

ORAL SOLUTION N/A WILLIAM RANSOM &SON PLC

UNITED KINGDOM

KAOLIN AND MORPHINEMIXTURE BP

ORAL SOLUTION N/A LCM LTD UNITED KINGDOM

KAPARLON-S TAB. 5MG TABLET 5MG ANFARM HELLAS S.A.-PHARMACEUTICALS

GREECE

KAPARLONS-S TABLETS 20MG ANFARM HELLAS S.A. GREECE

KARDEGIC 160MG POWDER FOR ORALSOLUTION

160MG LABORATOIRESSYNTHELABO

FRANCE

KARDEGIC 300MG POWDER FOR ORALSOLUTION

300MG LABORATOIRESSYNTHELABO

FRANCE

KARVOL DECONGESTANTCAPSULES

POWD. FORINHALATION SOLN

N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

KATAVAL CREAM NA FARMIGEA SPA ITALY

KATOXYN POWDER SPRAY N/A DEVERGE' MEDICINA EMEDICALIZZAZIONE SRL

ITALY

K-COR-5 TABLET 5MG MACLEODS INDIA

KEFLEX CAPSULE 250MG ELI LILLY ITALIA S.P.A. ITALY

KEFLEX CAPSULE 500MG ELI LILLY ITALIA S.P.A. ITALY

KEFLEX GRANULES FOR ORALSUSPEN.

125MG/5ML ELI LILLY ITALIA S.P.A. ITALY

KEFLIN NEUTRO POWDER FOR INJECTION 1000MG ELI LILLY ITALIA S.P.A. ITALY

KEFORAL HARD CAPSULE 250MG ELI LILLY ITALIA S.P.A. ITALY

KEFORAL HARD CAPSULE 500MG ELI LILLY ITALIA S.P.A. ITALY

KEFTID POWDER FOR ORALSUSPENSIO

125MG/5ML GALEN LIMITED UNITED KINGDOM

KEFTID POWDER FOR ORALSUSPENSIO

250MG/5ML GALEN LIMITED UNITED KINGDOM

KEFTID CAPSULES 500MG GALEN LIMITED UNITED KINGDOM

KEFTID CAPSULES 250MG GALEN LIMITED UNITED KINGDOM

KEFUROX POWDER FOR INJECTION 1500MG ELI LILLY ITALIA S.P.A. ITALY

KEFUROX POWDER FOR INJECTION 750MG ELI LILLY ITALIA S.P.A. ITALY

KEFUROX POWDER FOR INJECTION 250MG ELI LILLY ITALIA S.P.A. ITALY

KEMADRIN TABLETS 5MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

KEMADRIN SOLUTION FORINJECTION

5MG/ML THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

KEMADRIN TABLETS 5MG GLAXOSMITHKLINEGMBH & CO KG

GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 599

Trade Name Dosage Form Dose MA Holder Country

KEMADRIN INJECTION 10MG/2ML SOLUTION FORINJECTION

0.5% W/V THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

KENACOMB CREAM N/A BRISTOL-MYERS SQUIBBS.P.A

ITALY

KENACOMB OINTMENT N/A BRISTOL-MYERS SQUIBBS.P.A

ITALY

KENACORT INJECTABLE SUSPENSION 40MG/ML BRISTOL MYERS SQUIBBS.P.A.

ITALY

KENACORT «A RETARD» SOLUTION FORINJECTION

40MG/ML BRISTOL MYERS SQUIBBS.P.A

ITALY

KENALOG IN ORABASE PASTE 0.1G/100G SQUIBB INDUSTRIAFARMACEUTICA, S.A.

SPAIN

KEPPRA FILM-COATED TABLETS 250MG UCB S.A.(PHARMASECTOR)

EUROPEAN COMMUNITY

KEPPRA FILM-COATED TABLETS 500MG UCB S.A.(PHARMASECTOR)

EUROPEAN COMMUNITY

KEPPRA FILM-COATED TABLETS 1000MG UCB S.A.(PHARMASECTOR)

EUROPEAN COMMUNITY

KESTIN 10MG FILM COATED TABLET 10MG LABS SPECIA FRANCE

KETEK TABLETS 400MG AVENTIS PHARMA S.A. FRANCE

KETESSE TABLET 25MG MENARINIINTERNATIONALOPERATIONSLUXEMBOURG S.A.

ITALY

KETODOL TABLET N/A ALFA WASSERMANNS.P.A.

ITALY

KETOFTIL EYE DROPS 0.05% FARMIGEA SPA ITALY

KETOFTIL OPHTHALMIC GEL 0.05% FARMIGEA SPA ITALY

KETOFTIL OPHTHALMIC GEL 0.05% FARMIGEA SPA ITALY

KETORAL MEDICAL SHAMPOO N/A BILIM ILAC SANAYII VETICARET A.S.

TURKEY

KETORAL MEDICAL SHAMPOO SHAMPOO N/A BILIM ILAC SANAYII VETICARET A.S

TURKEY

KETRAX TABLETS 47.2MG ZENECA LIMITED UNITED KINGDOM

KETRAX SYRUP 0.944% W/V ZENECA LIMITED UNITED KINGDOM

KETRAX COATED TABLETS 40MG ZENECA LIMITED UNITED KINGDOM

KETRAX SYRUP ORAL SOLUTION 40MG/5ML ZENECA LIMITED UNITED KINGDOM

KIDDI PHARMATON SYRUP N/A PHARMATON SA SWITZERLAND

KIDDI PHARMATON (KIDDIPHARMATON FIZZ)

EFFERVESCENT TABLET N/A PHARMATON SA SWITZERLAND

KINUSSEN TABLETS 10MG KLEVA LTD GREECE

KLACID GRANULES FOR ORALSUSP.

125MG/5ML ABBOTT AG ITALY

KLACID FILMTAB TABLETS 250MG ABBOTT AG SWITZERLAND

EL600 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

KLACID TABLETS 250MG ABBOTT S.P.A ITALY

KLACID GRANULES FORSUSPENSION

125MG/5ML ABBOTT S.P.A. ITALY

KLACID COATED TABLET 500MG ABBOTT SPA ITALY

KLACID LA MODIFIED RELEASETABLETS

500MG ABBOTT LABORATORIES(IRELAND) LTD

IRELAND

KLACID RM SR COATED TABLETS 500MG ABBOTT S.P.A. ITALY

KLACID XL TABLETS 500MG ABBOTT LABORATORIESS.A (PTY)

SOUTH AFRICA

KLACID XL TABLETS MODIFIED RELEASETABLETS

500MG ABBOTT LABORATORIESS.A (PTY) LIMITED

SOUTH AFRICA

KLAMOKS 156.25MG PED. POWDER FOR O.SUSPEN

N/A BILIM ILAC SANAYII VETICARET A.S

TURKEY

KLAMOKS 156.25MG PAEDIATRIC DRY POWDER FOR ORALSUSP.

N/A BILIM ILAC SANAYII VETICARET A.S.

TURKEY

KLAMOKS 625MG FILM COATED TABLETS N/A BILIM ILAC SANAYII VETICARET A.S.

TURKEY

KLAMOKS 625MG FILM COATED TABLET N/A BILIM ILAC SANAYII VETICARET A.S

TURKEY

KLAMOKS BID TABLETS 1000MG BILIM ILAC SANAYII VETICARET A.S

TURKEY

KLAMOKS BID 200/28MG DRY POWDER FOR ORALSUSP.

N/A BILIM ILAC SANAYII VETICARET A.S.

TURKEY

KLAMOKS BID FORTE 200/28MG POWDER FOR OR.SUSPENSION

N/A BILIM ILAC SANAYII VETICARET A.S

TURKEY

KLAMOKS BID FORTE 400/57MG DRY POWDER FOR ORALSUSP.

N/A BILIM ILAC SANAYII VETICARET A.S.

TURKEY

KLAMOKS BID FORTE 400/57MG POWDER FOR OR.SUSPENSION

N/A BILIM ILAC SANAYII VETICARET A.S.

TURKEY

KLAMOKS-BID 1000MG FILM COATED TABLET N/A BILIM ILAC SANAYI VETICARET A.S

TURKEY

KLARICID TABLET 250MG ABBOTT PAKISTAN

KLARICID COATED TABLETS 500MG ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

KLARICID 500MG IV POWDER FOR IVINJECTION

500MG ABBOTT LABORATORIESLTD.

UNITED KINGDOM

KLARICID XL TABLET 500MG ABBOTT PAKISTAN

KLARICID XL 500MG MODIFIED RELEASETABLETS

500MG ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

KLEAN PREP POWDER N/A NORGINE LIMITED UNITED KINGDOM

KLEAN-PREP ORAL POWDER N/A HELSINN BIREXPHARMACEUTICALS LTD.

IRELAND

KLERIMED TABLETS 250MG MEDOCHEMIE LIMITED CYPRUS

KLEVASIN CAPSULE 500MG KLEVA LTD. GREECE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 601

Trade Name Dosage Form Dose MA Holder Country

KLEVASIN POWDER FOR ORALSUSP.

500MG/5ML KLEVA LTD GREECE

KLEVISTAMIN TABLET 1MG KLEVAPHARMACEUTICALLABORATORIES LTD

GREECE

KLEVISTAMIN SYRUP 1MG/5ML KLEVAPHARMACEUTICALLABORATORIES LTD

GREECE

KLEVISTAMIN TABLETS 1MG KLEVA LIMITED GREECE

KLEVISTAMIN SYRUP 1MG/5ML KLEVA LIMITED GREECE

KLIACEF GRANULES FOR ORALSUSP.

5% W/V FONTEN FARMACEUTICIS.R.L.

ITALY

KLIACEF CAPSULE 500MG FONTEN FARMACEUTICIS.R.L.

ITALY

KLIACEF TABLET 500MG FONTEN FARMACEUTICIS.R.L.

ITALY

KLINDAM CAPSULE 150MG PRIMEPHARMACEUTICALSDN.BHD.

MALAYSIA

KLINDAN CAPSULE 150MG BILIM ILAC CANAYII VETICARET SA

TURKEY

KLINDAN 300MG AMPUL SOLUTION FORINJECTION

300MG/2ML BILIM ILAC SANAYII VETICARET A.S

TURKEY

KLIOGEST -28 TABLETS TABLET NA NOVO NORDISK A/S DENMARK

KLISMACORT RECTAL CAPSULES 100MG BENE-ARZNEIMITTELGMBH

GERMANY

KLONT 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

KLOVIREKS 250MG POWDER FOR INJECTION 250MG MUSTAFA NEVZAT ILACSANAYII A.S.

TURKEY

KLOVIREKS-L ENJEKTABL FREEZE-DRIED POW.F/INJ. 250MG MUSTAFA NEVZAT ILACSANAYII A.S.

TURKEY

KOATE-DVI (ANTIHEMOPHILICFACTOR, HUMAN)

POWDER FOR INJECTION 9-22IU/MG PROT. BAYER CORPORATION,PHARMACEUTICAL DIV.

UNITED STATES OFAMERICA

KONSYL-ORANGE SUGAR FREE POWDER FOR ORALSUSP.

60.3% W/W EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

KRATIUM 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

KRATIUM 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

KROTER CREAM CREAM 10% W/W CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

KYTRIL FILM COATED TABLETS 1MG ROCHE PHARMASCHWEIZ LTD.

SWITZERLAND

KYTRIL INFUSION 3MG/3ML SOLUTION FORINJECTION

3MG/3ML SMITHKLINE BEECHAMPLC

UNITED KINGDOM

KYTRIL PAEDIATRIC LIQUID ORAL LIQUID 200MCG/ML SMITHKLINE BEECHAMPLC

UNITED KINGDOM

KYTRIL TABLETS 1MG COATED TABLET 1MG SMITHKLINE BEECHAMPLC

UNITED KINGDOM

EL602 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LABETALOL TABLETS 200MG COATED TABLET 200MG GENERICS (UK) LIMITED UNITED KINGDOM

LABOSEPT PASTILLES 0.25MG LOZENGE 0.25MG LABORATORIES FORAPPLIED BIOLOGY LTD

UNITED KINGDOM

LACIPIL TABLETS 4MG GALXO WELLCOME S.A. SPAIN

LACIPIL 4MG TABLETS FILM COATED TABLET 4MG GLAXO WELLCOME S.A. SPAIN

LACRIGEL OPHTHALMIC GEL N/A FARMIGEA SPA ITALY

LACRINORM OPHTHALMIC GEL N/A FARMIGEA SPA ITALY

LACTATED RINGERS AND 5%DEXTROSE INJ.

SOLUTION FORINJECTION

NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

LACTATED RINGER'S INJECTION SOLUTION FOR IVINFUSION

N/A DEMO SA GREECE

LACTATED RINGERS INJECTIONDEMO

SOLUTION FORINFUSION

NA DEMO SA GREECE

LACTATED RINGERS INJECTIONUSP

SOLUTION FORINJECTION

NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

LACTATED RINGER'S INJECTION,USP

SOLUTION FOR IVINFUSION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

LACTEOL FORT CAPSULE N/A LABORATOIRE DULACTEOL DU DOCTEURBOUCARD

FRANCE

LACTEOL FORT SACHET POWDER FOR ORALSUSPEN.

N/A LABORATOIRE DULACTEOL DU DOCTEURBOUCARD

FRANCE

LACTICARE (FORMERLY K/AOILATUM LOTION)

TOPICAL EMULSION N/A STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

LACTO CALAMINE LOTION TOPICAL SUSPENSION N/A SCHERING-PLOUGHLIMITED

UNITED KINGDOM

LACTULOSE SOLUTION (LAXOSE) ORAL SOLUTION 3.35G/5ML APPROVEDPRESCRIPTION SERVICESLIMITED

UNITED KINGDOM

LAMETEC-100 TABLET 100MG CIPLA INDIA

LAMICTAL TABLETS 25MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

LAMICTAL TABLETS 50MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

LAMICTAL TABLETS 100MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

LAMICTAL TABLETS 100MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

LAMICTAL TABLET 25MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

LAMICTAL TABLETS 50MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

LAMICTAL DISPERSIBLE TABLET FOR ORALSOLUTION

5MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

LAMICTAL DISPERSIBLE 25MGTABLETS

TABLET FOR ORALSOLUTION

25MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 603

Trade Name Dosage Form Dose MA Holder Country

LAMICTAL DISPERSIBLE 5MGTABLETS

TABLETS FOR ORALSOLUTION

5MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

LAMICTAL TABLETS TABLETS 25MG GLAXOWELLCOME PAKISTAN

LAMICTAL TABLETS TABLETS 100MG GLAXOWELLCOME PAKISTAN

LAMIFEN TABLETS 250 MG TABLET 250MG ALFARESPHARMACEUTICALS

SYRIA

LAMIFIN TABLET 250MG ALFARESPHARMACEUTICALS

SYRIA

LAMIFIN 1% CREAM 1% W/W ALFARESPHARMACEUTICALS

SYRIA

LAMIFIN CREAM 1% CREAM 10MG/G ALFARESPHARMACEUTICALS

SYRIA

LAMISIL TOPICAL SOLUTION 10MG/G NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LAMISIL SPRAY 10MG/G NOVARTIS PHARMA(SCHWEIZ) AG

SWITZERLAND

LAMISIL DERMGEL 10MG/G NOVARTIS PHARMA(SCHWEIZ) AG

SWITZERLAND

LAMISIL TABLETS 250MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LAMISIL CREAM 1% W/W NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LAMISIL CREAM 10MG/G NOVARTIS PAKISTAN

LAMISIL TABLETS 125MG NOVARTIS PAKISTAN

LAMISIL TOPICAL SOLUTION 10MG/G NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LAMISIL SPRAY 10MG/G NOVARTIS PHARMA(SCHWEIZ) AG

SWITZERLAND

LAMISIL CREAM 1% W/W NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LAMISIL TABLETS 250MG NOVARTIS FARMA SPA ITALY

LAMOTRIGINE DISPERSIBLE TABLET FOR ORALSOLUTION

25MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

LANACANE CREME CREAM 3%W/W COMBE INTERNATIONALLIMITED

UNITED KINGDOM

LANES MOD. HERB. COLD ANDCATARRH TABLETS.

COATED TABLET N/A MODERN HEALTHPRODUCTS

UNITED KINGDOM

LANES MOD. HERB. RHEUMATICPAIN TABLETS

COATED TABLET N/A MODERN HEALTHPRODUCTS LTD

UNITED KINGDOM

LANES MOD. HERB. TRAPPEDWIND AND INDIGEST

TABLET 125MG G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

LANES MOD. HERB. WATERRETENTION TABS.

COATED TABLET N/A MODERN HEALTHPRODUCTS LTD

UNITED KINGDOM

LANES MOD. HERBALS SLEEP AIDPASSIFLORA

TABLET 22MG G R LANE HEALTHPRODUCTS

UNITED KINGDOM

LANES MOD. HERBALS STRESSTABLETS

COATED TABLET N/A METABASIC PRODUCTSLTD

UNITED KINGDOM

EL604 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LANES MODERN HERBALS COLDAND CONGESTION

ORAL SOLUTION N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

LANES MODERN HERBALSCOUGH MIXTURE

ORAL SOLUTION N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

LANES MODERN HERBALS FOOTBALM

OINTMENT N/A G R LANE HEALTHPRODUCT LTD

UNITED KINGDOM

LANES MODERN HERBALSLAXATIVE TABLETS

COATED TABLET N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

LANES MODERN HERBALSMENOPAUSE TABLET

COATED TABLET N/A METABASIC PRODUCTSLTD

UNITED KINGDOM

LANES MODERN HERBALSMUSCULAR PAIN CREAM

CREAM N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

LANES MODERN HERBALS PILEOINTMENT

OINTMENT N/A G R LANE HEALTHPRODUCTS

UNITED KINGDOM

LANES MODERN HERBALS PILETABLETS

COATED TABLET N/A GR LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

LANOXIN TABLETS 250MCG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

LANOXIN ELIXIR N/A GLAXO WELLCOMEGMBH & CO

GERMANY

LANOXIN — PG TABLETS TABLETS 62.5MCG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

LANOXIN INJECTION 1.25MG/5ML SOLUTION FORINJECTION

0.025% W/V THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

LANOXIN PAEDIATRIC ELIXIR ELIXIR 0.05G/1000ML THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

LANOXIN PG DIGOXIN 62.5MCGTABLETS

TABLET 62.5MCG SIGMAPHARMACEUTICALS PTYLTD.

AUSTRALIA

LANOXIN TABLET 250 MCG TABLET 0.25MG GLAXOSMITHKLINEGMBH & CO. LTD

GERMANY

LANSOX CAPSULE 15MG TAKEDA ITALIAFARMACEUTICI S.P.A.

ITALY

LANSOX CAPSULE 30MG TAKEDA ITALIAFARMACEUTICI S.P.A.

ITALY

LANSOYL 78.23% ORAL JELLY 78.23% W/W PARKE DAVIS FRANCE

LANTANON TABLETS TABLET 30MG ORGANON PAKISTAN

LANTIGEN B ORAL DROPS,SUSPENSION

N/A BRUSCHETTINI SRL ITALY

LANVIS TABLETS 40MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

LANVIS TABLETS 40MG TABLETS 40MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

LARGACTIL SOLUTION FORINJECTION

2.5% W/V HAWGREEN LTD. IRELAND

LARGACTIL INJECTION 2.5% W/V SOLUTION FORINJECTION

2.5% W/V HAWGREEN LIMITED IRELAND

LARGACTIL SYRUP 25MG/5ML ORAL SOLUTION 25MG/5ML HAWGREEN LIMITED IRELAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 605

Trade Name Dosage Form Dose MA Holder Country

LARGACTIL TABLETS 100MG COATED TABLET 100MG HAWGREEN LIMITED IRELAND

LARGACTIL TABLETS 25MG COATED TABLET 25MG HAWGREEN LIMITED IRELAND

LARGACTIL TABLETS 50MG COATED TABLET 50MG HAWGREEN LIMITED IRELAND

LARGOPEN CAPSULE 250MG BILIM ILAC SANAYII VETICARET AS

TURKEY

LARGOPEN 125MG/5ML POWDER FOR ORALSUSPEN.

125MG/5ML BILIM ILAC SANAYII VETICARET AS

TURKEY

LARIAM TABLETS 250MG ROCHE PHARMA(SCHWEIZ)AG

SWITZERLAND

LARMABAK EYE DROPS N/A LABORATOIRESTHEA FRANCE

LASILIX 20MG/2ML SOLUTION FORINJECTION

20MG/2ML LABORATOIRESHOECHST

FRANCE

LASILIX 40MG TABLET 40MG LABORATOIRESHOECHST

FRANCE

LASILIX RETARD 60MG SUSTAINED RELEASECAPSULE

60MG LABORATOIRESHOECHST

FRANCE

LASILIX SPECIAL 500MG TABLET 500MG LABORATOIRESHOECHST

FRANCE

LASIX TABLETS 40MG HOECHST MARIONROUSSEL

PAKISTAN

LASIX 40MG TABLET 40MG HOECHST MARIONROUSSEL

PAKISTAN

LASONIL OINTMENT N/A BAYER PLC UNITED KINGDOM

LASONIL OINTMENT 0.8% W/W BAYER PLC UNITED KINGDOM

LASONIL N OINTMENT 5000 HDB-E/100G BAYER VITAL GMBH &CO. KG

GERMANY

LASOPROL 15 CAPSULES 15MG AEGIS LTD. CYPRUS

LASOPROL 30 CAPSULES 30MG AEGIS LTD. CYPRUS

LATAN-N TABLET N/A WYETH-AYERSTCANADA INC

CANADA

LAXADIN (BISACODYL) TABLETS5MG

TABLET 5MG TEVAPHARMACEUTICALSINDUSTRIES LTD

ISRAEL

LEDERFOLIN 15MG TABLETS TABLET 15 MG CYANAMID IBERICA S.A. SPAIN

LEFUMIDE-10 FILM COATED TABLETS 10MG CIPLA LIMITED INDIA

LEMLAX ORAL LIQUID 3.26G/5ML CO-PHARMA LIMITED UNITED KINGDOM

LEMON ENO POWDER FOR ORALSOLUTION

N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

LEMSIP CHESTY COUGH LIQUID LIQUID 50MG/5ML RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP CHILDREN'S SIX+ COLDAND FLU RELIEF

POWDER FOR ORALSOLUTION

N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

EL606 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LEMSIP COLD + FLUBLACKCURRANT

POWDER FOR ORALSOLUTION

N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP COLD + FLU BREATHEEASY

POWDER FOR ORALSOLUTION

N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP COLD + FLU MAXSTRENGTH

POWDER FOR ORALSOLUTION

N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP COLD + FLU MAXSTRENGTH CAPSULES

CAPSULE N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP COLD + FLU ORIGINALLEMON

POWDER FOR ORALSOLUTION

N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP DRY TICKLY COUGHLIQUID

LIQUID N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP FLU STRENGTH POWDER POWDER N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP PHARMACY POWERCAPS MODIFIED RELEASECAPSULE

N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP POWDER POWDER N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP POWER + POWDER POWDER N/A RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

LEMSIP SORE THROATANTI-BACTERIAL

LOZENGE 2.4MG ERNEST JACKSON & COLIMITED

UNITED KINGDOM

LEMSIP SORE THROATANTI-BACTERIAL CITRUS

LOZENGE 2.4MG ERNEST JACKSON & COLIMITED

UNITED KINGDOM

LEN VK 250MG TABLET 250MG PHARMACARE LIMITED— SOUTH AFRICA

SOUTH AFRICA

LENNON — DAPSONE 100MG TABLET 100MG PHARMACARE LIMITED SOUTH AFRICA

LENOCEF -125 SUSPENSION SUSPENSION 125MG PHARMACARE LIMITED -SOUTH AFRICA

SOUTH AFRICA

LENOCEF-250 CAPSULES 250MG PHARMACARE LIMITED-SOUTH AFRICA

SOUTH AFRICA

LENOLAX LIQUID NA PHARMACARE LIMITED REPUBLIC OF SOUTHAFRICA

LEPONEX TABLETS 25MG NOVARTIS PHARMAGMBH

AUSTRIA

LEPONEX TABLETS 100MG NOVARTIS PHARMAGMBH

AUSTRIA

LEPONEX TABLETS 25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LEPONEX TABLETS 100MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LEPONEX TABLETS 25MG NOVARTIS PHARMASCHWEIZ

SWITZERLAND

LEPONEX TABLETS 100MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LEPONEX 100MG TABLETS 100MG NOVARTIS PHARM. UK.LTD. T/A SANDOZPHARM.

SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 607

Trade Name Dosage Form Dose MA Holder Country

LEPONEX 25MG TABLETS 25MG NOVARTIS PHARM. UKLTD. T/A SANDOZPHARM.

SWITZERLAND

LEPUR FILM COATED TABLETS 5MG KLEVA LTD. GREECE

LEPUR FILM COATED TABLETS 10MG KLEVA LTD. GREECE

LEPUR FILM COATED TABLETS 20MG KLEVA LTD. GREECE

LESCOL CAPSULES 20MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LESCOL CAPSULES 40MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LESCOL CAPSULE 20MG NOVARTIS PAKISTAN

LESCOL CAPSULES 40MG NOVARTISFARMACEUTICA S.A

SPAIN

LESCOL CAPSULES 20MG NOVARTISFARMACEUTICA S.A

SPAIN

LESCOL FORTE PROLONGED RELEASETABLETS

80MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LESCOL XL SLOW RELEASE TABLETS 80MG NOVARTISFARMACEUTICA S.A

SPAIN

LESCOL XL 80MG PROLONGEDRELEASE TABLETS

FILM-COATED TABLETS 80 MG NOVARTISPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

LEUCOVORIN CALCIUM FOLINICACID INJ. VIA

SOLUTION FORINJECTION

50MG/ML F.H. FAULDING & CO.LTD (T/A DAVID BULLLABS)

AUSTRALIA

LEUKERAN COMPRESSION-COATEDTABLET

2MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

LEUKERAN COMPRESSION-COATEDTABLET

5MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

LEUKERAN TABLETS 2MG TABLET 2MG THE WELLCOMEFOUNDATION LTD T/AGLAXO WELLCOME

UNITED KINGDOM

LEVOMED 100/10MG TABLET N/A MEDOCHEMIE LTD CYPRUS

LEVOMED 250/25MG TABLET N/A MEDOCHEMIE LTD CYPRUS

LEVOPHED SOLUTION FORINJECTION

1MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

LEVOPHED SOLUTION FORINJECTION

4MG/4ML(1MG/ML) ABBOTT LABORATORIES UNITED STATES OFAMERICA

LEVOPRONT SYRUP 0.6G/ML DOMPE FARMACEUTICISPA

ITALY

LEVOVIST GRANULES FORINJECTION

N/A SCHERING AG GERMANY

LEVSIN/SL TABLETS N/A SCHWARZ PHARMA INC UNITED STATES OFAMERICA

LEXILIUM 6 TABLETS 6MG REMEDICA LTD CYPRUS

LEXOMIL (BROMAZEPAM) TABLETS (30) 6MG ROCHE S.A. MOROCCO

LEXOMIL 3MG TABLET 3MG PRODUIT ROCHE S.A. MOROCCO

EL608 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LIBERTY ASPIRIN TABLETS 300MG OBG PHARMACEUTICALSLTD

UNITED KINGDOM

LIBERTY PARACETAMOL TABLETS 500MG OBG PHARMACEUTICALSLTD

UNITED KINGDOM

LIBERTY 'PARACIN' FILM COATED TABLETS 500MG OBG PHARMACEUTICALSLTD

UNITED KINGDOM

LIBRIUM CAPSULES 10MG CAPSULES 10MG ICN PHARMACEUTICALSLTD

UNITED KINGDOM

LIBRIUM CAPSULES 5MG CAPSULES 5MG ICN PHARMACEUTICALSLTD

UNITED KINGDOM

LIBROFEM FILM COATED TABLET 200MG EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

LIBROFEM TABLETS FILM COATED TABLET 200MG EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

LIDOCAINE (LIGNOCAINE)LARYNGOJET

SOLUTION FORINJECTION

4%W/V INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

LIDOCAINE (LIGNOCAINE)MINIJET

SOLUTION FORINJECTION

2%W/V INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

LIDOCAINE (LIGNOCAINE) MINJET SOLUTION FORINJECTION

1%W/V INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

LIDOCAINE 5%W/V ANDPHENYLEPHRINE 0.5%W/V

TOPICAL SOLUTION N/A AURUMPHARMACEUTICALSLIMITED

UNITED KINGDOM

LIDOCAINE HCL ANDEPINEPHRINE INJ USP

SOLUTION FORINJECTION

NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

LIDOCAINE HYDROCHLORIDE SOLUTION FORINJECTION

1G/50ML PHARMAMEDPARENTERALS LTD.

MALTA

LIDOCAINE INJECTION MINIJET1%W/V

AQUEOUS SOLUTION 10MG/ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

LIDOCAINE INJECTION MINIJET2%W/V

AQUEOUS SOLUTION 20MG/1ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

LIDOCAINE LARYNGOJET 4%W/V SOLUTION FOR TOPICALUSE

4%W/V INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

LIDOCATON 2% 1:80 000 SOLUTION FORINJECTION

N/A WEIMER PHARMA GMBH GERMANY

LIFESOL 0.9% (NACL) IVSOLUTION

SOLUTION FOR IVINJECTION

0.9% W/V GEOFMANPHARMACEUTICALS

PAKISTAN

LIFESOL 5% I.V. SOLUTION(DEXTROSE 5%)

SOLUTION FOR IVINJECTION

5% W/V GEOFMANPHARMACEUTICALS

PAKISTAN

LIFUROX POWDER FOR IV/IMINJECT.

250MG ELI LILLY ITALIA S.P.A. ITALY

LIFUROX POWDER FOR IV/IMINJECT.

750MG ELI LILLY ITALIA S.P.A. ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 609

Trade Name Dosage Form Dose MA Holder Country

LIFUROX POWDER FOR IV/IMINJECT.

1500MG ELI LILLY ITALIA S.P.A. ITALY

LIGNOCAINE 0.5% WITHADRENALINE

AQUEOUS SOLUTION INJ N/A INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

LIGNOCAINE HCL INJ. WITHADRENALINE

SOLUTION FORINJECTION

N/A INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

LIGNOCAINE HYDROCHLORIDE SOLUTION FORINJECTION

2.% W/V ANTIGENPHARMACEUTICALS LTD

IRELAND

LIGNOCAINE HYDROCHLORIDE SOLUTION FORINJECTION

BP 1.0% W/V ANITGENPHARMACEUTICALSLIMITED

IRELAND

LIGNOCAINE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTION

2%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

LIGNOCAINE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTION

2%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

LIGNOCAINE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTION

2%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

LIGNOCAINE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTION

1%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

LIGNOCAINE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTION

1%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

LIGNOCAINE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTIONS

1%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

LIGNOCAINE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTION

1%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

LIGNOSPAN FORTE SOLUTION FORINJECTION

N/A DEPROCO INC. UNITED STATES OFAMERICA

LIGNOSPAN SPECIAL SOLUTION FORINJECTION

N/A LABORATOIRESSEPTODONT

FRANCE

LIGNOSPAN STANDARD SOLUTION FORINJECTION

N/A DEPROCO INC. UNITED STATES OFAMERICA

LIMITROL TABLETS 10MG PHARMA EVO PAKISTAN

LINCOCIN CAPSULES 500MG PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

LINCOCIN SOLUTION FORINJECTION

600MG/2ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

LINDASOL SOLUTION FOREXTERNAL USE

1% W/V KLEVA LTD GREECE

LIORESAL TABLETS 10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LIORESAL TABLETS 25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EL610 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LIORESAL TABLETS 25MG NOVARTISFARMACEUTICA S.A

SPAIN

LIOTON «1000» GEL 100000 IU/100G SANOFI WINTHROPS.P.A.

ITALY

LIPANTHYL 100MG CAPSULE 100MG LABORATOIRESFOURNIER SCA

FRANCE

LIPANTHYL 200MG CAPSULE 200MG LABORATOIRESFOURNIER SA

FRANCE

LIPANTHYL 300MG CAPSULE 300MG LABORATOIRESFOURNIER SCA

FRANCE

LIPITOR COATED TABLETS 10MG WARNER LAMBERTEXPORT LIMITED

IRELAND

LIPITOR COATED TABLETS 20MG WARNER LAMBERTEXPORT LTD

IRELAND

LIPITOR COATED TABLETS 40MG WARNER LAMBERTEXPORT LIMITED

IRELAND

LIPITOR TABLETS 10MG COATED TABLET 10MG WARNER LAMBERTEXPORT LTD T/A PARKEDAVIS RESEARCH LABS

UNITED KINGDOM

LIPITOR TABLETS 40MG COATED TABLET 40MG WARNER LAMBERTEXPORT LTD T/A PARKEDAVIS RESEARCH LABS

UNITED KINGDOM

LIPOBAY 0,4 FILM-COATED TABLET 0.4MG BAYER VITAL GMBH GERMANY

LIPOBAY 0.1 FILM-COATED TABLET 0.1MG BAYER VITAL GMBH &CO. KG

GERMANY

LIPOBAY 0.2 FILM-COATED TABLET 0.2MG BAYER VITAL GMBH GERMANY

LIPOBAY 0.3 FILM-COATED TABLET 0.3MG BAYER VITAL GMBH GERMANY

LIPOFUNDIN MCT/LCT 10% EMULSION N/A B.BRAUN MELSUNGENAG

GERMANY

LIPOFUNDIN MCT/LCT 20% EMULSION N/A B.BRAUN MELSUNGENAG

GERMANY

LIPOFUNDIN N 10% EMULSION FORINFUSION

100G/1000ML B.BRAUN MELSUNGENAG

GERMANY

LIPOFUNDIN N 20% EMULSION FORINFUSION

200G/1000ML B.BRAUN MELSUNGEN GERMANY

LIPOFUNDIN S 10% EMULSION N/A B.BRAUN MELSUNGENAG

GERMANY

LIPOFUNDIN S 20% EMULSION N/A B.BRAUN MELSUNGENAG

GERMANY

LIPOGRASIL COATED TABLET N/A J.URIACH & CIA. S.A. SPAIN

LIPO-MERZ RETARD CAPSULES 500MG MERZ+CO. GMBH & CO. GERMANY

LIPOSTAT TABLETS 10MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

LIPOSTAT TABLETS 20MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

LIPOSTAT TABLETS 20MG BRISTOL-MYERS SQUIBBCOMPANY

UNITED STATES OFAMERICA

LIPOSTAT (SELECTIN) TABLETS 10MG BRISTOL-MYERS SQUIBBS.P.A

ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 611

Trade Name Dosage Form Dose MA Holder Country

LIPOSTAT (SELECTIN) TABLETS 20MG BRISTOL-MYERS SQUIBBS.P.A

ITALY

LIPOSYN II 20% IV FAT EMULSION IV FAT EMULSION 20% ABBOTT LABORATORIES UNITED STATES OFAMERICA

LIPOSYN II INTRAVENOUS FATEMULSION

INTRAVENOUS FATEMULSION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

LIPOSYN III 10% INTRAVENOUSEMULSION

100MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

LIQUID PARAFFIN B.P. ORAL SOLUTION 100% V/V WILLIAM RANSOM &SON PLC

UNITED KINGDOM

LIQUID PARAFFIN BP ORAL LIQUID 100%V/V LCM LTD UNITED KINGDOM

LIQUID PARAFFIN BP LIQUID 100% V/V PINEWOODLABORATORIES LTD T/APINEWOODHEALTHCARE

IRELAND

LISKOMET TABLET TABLET 250MG LISKO PAKISTAN

LISOCARD TABLETS 5MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

LISOCARD TABLETS 10MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

LISOPRIL TABLET 2.5MG DELTA HF ICELAND

LISOPRIL TABLET 5MG DELTA HF ICELAND

LISOPRIL TABLET 10MG DELTA HF ICELAND

LISOPRIL TABLET 20MG DELTA HF ICELAND

LISORIL-10 (LISINOPRIL TABLETSUSP)

TABLET 10MG IPCA LABORATORIESLIMITED

INDIA

LISORIL-5 (LISINOPRIL TABLETSUSP)

TABLET 5MG IPCA LABORATORIESLIMITED

INDIA

LISTERINE ANTISEPTIC LIQUID N/A WARNER-LAMBERT S.A.(PTY) LTD

SOUTH AFRICA

LITHIMOLE EYE DROPS SOLUTION 0.25% W/V COOPER S.A. GREECE

LITHIMOLE EYE DROPS SOLUTION 0.5% W/V COOPER S.A. GREECE

LITHONATE CR 400MG CONTROLLED RELEASETABLET

400MG APPROVEDPRESCRIPTION SERVICESLTD

UNITED KINGDOM

LIVIAL TABLETS 2.5MG TABLET 2.5MG ORGANONLABORATORIES LIMITED

UNITED KINGDOM

LIVOSTIN NASAL SPRAY 0.5MG/ML JANSSEN-CILAG N.V. BELGIUM

LIVOSTIN EYE DROPS 0.5MG/ML JANSSEN-CILAG N.V. BELGIUM

LOBELIA TABLETS COATED TABLET N/A CATHAY OFBOURNEMOUTH LTD

UNITED KINGDOM

LOCABIOTAL 1% NASAL/BUCCAL INHAL.SOLN.

1% W/V LABORATOIRES SERVIER FRANCE

LOCACORTEN — VIOFORM EAR DROPS N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EL612 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LOCACORTEN-VIOFORM CREAM N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LOCASALEN OINTMENT N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LOCERYL CREAM CREAM 0.25%W/W GALDERMA (UK) LIMITED UNITED KINGDOM

LOCERYL NAIL LACQUER 5% TOPICAL SOLUTION 5%W/V GALDERMA (UK) LIMITED UNITED KINGDOM

LOCOID LIPOCREAM 1MG/G YAMANOUCHI PHARMAB.V.

NETHERLANDS

LOCOID OINTMENT 1MG/G YAMANOUCHI PHARMAB.V.

NETHERLANDS

LOCOID CREAM 1MG/G YAMANOUCHI PHARMAB.V.

NETHERLANDS

LOCOID C CREAM CREAM N/A YAMANOUCHI PHARMALIMITED

UNITED KINGDOM

LOCOID CRELO 0.1% TOPICAL EMULSION 1MG/G YAMANOUCHI PHARMAB.V.

NETHERLANDS

LOCOID SCALP LOTION 1MG/ML YAMANOUCHI PHARMAB.V.

NETHERLANDS

LOGYNON COATED TABLET N/A SCHERING AG GERMANY

LOGYNON (SH B 264 AB) COATED TABLET N/A SCHERING HEALTH CARELIMITED

UNITED KINGDOM

LOMAC -20 CAPSULES 20MG CIPLA INDIA

LOMARIN TABLETS 50MG GEYMONAT SPA ITALY

LOMARIN TABLETS 50MG GETMONAT SPA ITALY

LOMEXIN VAGINAL CREAM 2G/100G RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

LOMEXIN DERMATOLOGICALPOWDER

2G/100G RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

LOMEXIN VAGINAL SOLUTION 0.2G/100ML RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

LOMEXIN SOLUTION, SPRAY 2G/100G RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

LOMEXIN CREAM 2G/100G RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

LOMEXIN «T» VAGINALOVULE(CAPSULE)

1000MG RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

LOMEXIN SOLUTION 2G/100ML RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

LOMEXIN VAGINALOVULE(CAPSULE)

200MG RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 613

Trade Name Dosage Form Dose MA Holder Country

LOMEX-T GASTRO RESISTANTTABLETS

20MG OMEGA FARMA ICELAND

LOMIR TABLETS 2.5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LOMIR SRO CAPSULES 5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LOMOTIL TABLETS N/A MONSANTO PLC UNITED KINGDOM

LOMOTIL TABLETS 2.5MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

LOMOTIL TABLETS N/A SEARLE PAKISTAN

LOMOTIL TABLETS N/A GOLDSHIELDPHARMACEUTICALSLIMITED T/AGOLDSHIELDPHARMACEUT

UNITED KINGDOM

LONITEN TABLETS 10MG PHARMACIA LIMITED UNITED KINGDOM

LONITEN 10MG TABLET 10MG PHARMACIA & UPJOHNINC.

CANADA

LOPAMID CAPSULE 2MG THE ACMELABORATORIES LTD.

BANGLADESH

LOPEDIUM CAPSULE 2MG HEXAL AG GERMANY

LOPERAMIDE CAPSULES 2MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

LOPERAMIDE 2MG CAPSULES 2MG APPROVEDPRESCRIPTION SERVICESLTD

UNITED KINGDOM

LOPERAMIDE COATED TABLETS2MG

COATED TABLET 2MG LABORATORIOBENGUEREL LTDA

CHILE

LOPERAMIDE HYDROCHLORIDE TABLETS 2MG PHARMAMED LTD. GERMANY

LOPERAMIDE HYDROCHLORIDE CAPSULES 2MG GENERICS (UK) LIMITED UNITED KINGDOM

LOPERAN CAPSULES 2MG CHIESI ESPANA S.A. SPAIN

LOPERAN 2MG CAPSULE 2MG CHIESI WASSERMANNS.A.

SPAIN

LOPID 600 FILMCOATED TABLET 600MG PARKE-DAVIS GMBH GERMANY

LOPRESOR FILM COATED TABLETS 100MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LOPRESS 12.5 MG, TABLETS TABLETS 12.5 MG OMEGA FARMA EHF. ICELAND

LOPRESS 50 MG, TABLETS TABLETS 50 MG OMEGA FARMA EHF. ICELAND

LORANS 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

LORANS 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

LORAZEPAM TABLETS 1MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

LORAZEPAM TABLETS 2.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

EL614 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LORELIN DEPOT POWDER FOR INJECTION N/A DONG KOOK PHARM.CO. LTD

KOREA REPUBLIC

LORITIN TABLET 10MG DELTA HF ICELAND

LOSEC GASTRO-RESISTANTCAPSULES

10MG HASSLE LAKEMEDEL AB SWEDEN

LOSEC CAPSULES 20MG ASTRAPHARMACEUTICALSLIMITED

UNITED KINGDOM

LOSEC MUPS GASTRO-RESISTANTTABLETS

10MG HASSLE LAKEMEDEL AB SWEDEN

LOSEC MUPS GASTREO-RESISTANTTABLETS

20MG HASSLE LAKEMEDEL AB SWEDEN

LOSEC MUPS GASTRO-RESISTANTTABLETS

40MG HASSLE LAKEMEDEL AB SWEDEN

LOTRIDERM CREAM N/A SCHERING-PLOUGH S.A. BELGIUM

LUBEX LIQUID SKIN CLEANSINGEMULSION

30MG/G PERMAMED AG SWITZERLAND

LUBEXYL SUSPENSION 40MG/G PERMAMED AG SWITZERLAND

LUCRIN DEPOT POWDER FOR INJECTION 11.25MG/2ML ABBOTT AG SWITZERLAND

LUCRIN DEPOT 3.75MG SOLUTION FORINJECTION

3.75MG/VIAL ABBOTT LABORATORIESS.A

SPAIN

LUDIOMIL FILM COATED TABLETS 25MG NOVARTISFARMACEUTICA S.A.

SPAIN

LUDIOMIL FILM COATED TABLETS 10MG NOVARTISFARMACEUTICA S.A.

SPAIN

LUDIOMIL FILM COATED TABLETS 10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LUDIOMIL FILM COATED TABLETS 25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

LUDIOMIL TABLET 10MG CIBA PAKISTAN

LUDIOMIL TABLET 25MG CIBA PAKISTAN

LUDIOMIL SOLUTION FORINJECTION

N/A NOVARTIS PHARMAGMBH

AUSTRIA

LUMAREN INJECTABLE SOLUTION 50MG/2ML ELPEN PHARM. CO. INC. GREECE

LUMAREN COATED TABLET 150MG ELPEN PHARM. CO., INC. GREECE

LUMIGAN OPHTALMIC SOLUTION 0.03% ALLERGAN INC UNITED STATES OFAMERICA

LUSTRAL TABLET 100MG PFIZER LIMITED UNITED KINGDOM

LUSTRAL TABLET 50MG PFIZER LIMITED UNITED KINGDOM

LUSTYS GARLIC PERLES CAPSULE 0.66MG G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

LUTENYL TABLET 5MG LABORATOIRESTHERAMEX

FRANCE

LUTRAX SOLUTION 0.15MG/ML ALCON LABORATORIOS,S.A. DE C.V.

MEXICO

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 615

Trade Name Dosage Form Dose MA Holder Country

LYCLEAR 1% W/W CREME RINSE CREAM 1% W/W GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

LYOVAC COSMEGEN INJECTION0.5MG

POWDER FOR INJECTION 0.5MG MERCK SHRP & DOHMEB.V.

NETHERLANDS

LYSPAFEN TABLET N/A JANSSEN-CILAG AG SWITZERLAND

MAALOX SUSPENSION NA RORERPHARMACEUTICALSLIMITED

IRELAND

MAALOX «PLUS» TABLETS N/A RHONE POULENC RORERS.P.A.

ITALY

MAALOX NO.2 TABLET N/A RORERPHARMACEUTICALS LTD.(T/A RHONE POULENCRORER)

UNITED KINGDOM

MAALOX PLUS TABLET N/A RORERPHARMACEUTICALS LTD.(T/A RHONE POULENCRORER)

UNITED KINGDOM

MAALOX PLUS SUSPENSION N/A RORERPHARMACEUTICALS LTD.(T/A RHONE POULENCRORER)

UNITED KINGDOM

MAALOX PLUS TABLETS N/A RORERPHARMACEUTICALS

UNITED KINGDOM

MAALOX PLUS SUSPENSION NA RORERPHARMACEUTICALSLIMITED

IRELAND

MAALOX TC (THERAPEUTICCONCENTRATION)

SUSPENSION N/A RORERPHARMACEUTICALS LTD.(T/A RHONE POULENCRORER)

UNITED KINGDOM

MAALOX TC (THERAPEUTICCONCENTRATION)

TABLET N/A RORERPHARMACEUTICALS LTD.(T/A RHONE POULENCRORER)

UNITED KINGDOM

MABRON 50MG CAPSULE 50MG MEDOCHEMIE LTD CYPRUS

MABTHERA SOLUTION SOLUTION(VIALS) 100MG,500MG ROCHEPHARMA(SCHWEIZ) LTD.

SWITZERLAND

MACOREL CONTROLLED RELEASECAPS

20MG/CAP ELPEN PHARM. CO. INC. GREECE

MACOX ZH JR TABLETS N/A MACLEODSPHARMACEUTICALS LTD

INDIA

MACOX-150 TABLET 150MG MACLEODS INDIA

MACOX-150 CAPSULES 150MG MACLEODSPHARMACEUTICALS LTD

INDIA

MACOX-300 TABLET 300MG MACLEODSPHARMACEUTICALS LTD

INDIA

MACOX-300 CAPSULES 300MG MACLEODSPHARMACEUTICALS LTD

INDIA

MACOX-450 CAPSULES 450MG MACLEODSPHARMACEUTICALS LTD

INDIA

EL616 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MACOX-ZH TABLETS N/A MACLEODSPHARMACEUTICALS LTD

INDIA

MACRODANTIN CAPSULES 50MG PROCTOER & GAMBLEPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

MACRODANTIN CAPSULES 100MG PROCTER & GAMBLEPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

MACROZIDE-500 TABLET 500MG MACLEODS INDIA

MACROZIDE-750 TABLET 750MG MACLEODSPHARMACEUTICALS LTD

INDIA

MADOPAR 250MG TABLET N/A ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

MAG. PHOS. 6X NEW ERABIOCHEMIC NO.8

TISSUE SALT TABLETSNO.8

NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

MAGNESIA SAN PELLEGRINO(ANISE FLAVOUR)

ORAL POWDER 900MG/G SAPROCHI SA SWITZERLAND

MAGNESIA SAN PELLEGRINO(LEMON FLAVOUR)

ORAL POWDER 4.5G/10G SAPROCHI SA SWITZERLAND

MAGNESIUM COMPLEXE CAPSULE N/A LABORATOIRE GOLAZSA

SWITZERLAND

MAGNESIUM COMPLEXECAPSULES

CAPSULES NA LABORATOIRES GOLAZSA

SWITZERLAND

MAGNESIUM SULPHATE BP SOLUTION FORINJECTION

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

MAGNESIUM SULPHATE BP ORAL POWDER 100%W/W LCM LTD UNITED KINGDOM

MAGNESIUM SULPHATE PASTE BP PASTE N/A LCM LTD UNITED KINGDOM

MAGNESIUM SULPHATE PASTE BP PASTE N/A LCM LTD UNITED KINGDOM

MAGNESIUM SULPHATE PASTE BP PASTE N/A LCM LTD UNITED KINGDOM

MAGNESIUM TRISILICATE BP ORAL SUSPENSION N/A LCM LTD UNITED KINGDOM

MAGNESIUM TRISILICATE CO. BP TABLETS N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

MAGNEVIST SOLUTION FOR IVINJECTION

469MG/ML SCHERING AG GERMANY

MAGNEVIST SOLN. FOR IV INJECTION 469MG/ML SCHERING AG GERMANY

MAGRILAN 20MG CAPSULE 20MG MEDOCHEMIE LTD CYPRUS

MAGUROL 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

MANNITOL SOLUTION FORINJECTION

10% W/V BP GALEN RESEARCHLABORATORIES LIMITED

UNITED KINGDOM

MANNITOL 20% IV INFUSION SOLUTION FORINJECTION

200G/1L BAXTER HEALTHCARELIMITED

UNITED KINGDOM

MANNITOL INTRAVENOUSINFUSION 15%W/V

SOLUTION FORINJECTION

150G/1000ML BAXTER HEALTHCARELIMITED

UNITED KINGDOM

MANNITOL INTRAVENOUSINFUSON 10%W/V

SOLUTION FORINJECTION

10%W/V BAXTER HEALTHCARELIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 617

Trade Name Dosage Form Dose MA Holder Country

MANNITOL IV INFUSIONPOLYFUSOR M 20%BP

SOLUTION FORINJECTION

20%BP FRESENIUS LIMITED UNITED KINGDOM

MANNITOL/DEMO SOLUTION FOR IVINFUSION

200MG (20% W/V) DEMO SA GREECE

MANNS KNOBLAUCH PILLENPLUS

COATED TABLET N/A DR. GERHARD MANN,CHEM.-PHARM. FABRIKGMBH

GERMANY

MANUSEPT ANTIBACTERIALHAND RUB

TOPICAL SOLUTION N/A SETON PRODUCTS LTD UNITED KINGDOM

MARCAIN SOLUTION FORINJECTION

2.5MG/ML ASTRA LAKEMEDEL AB SWEDEN

MARCAIN SOLUTION FORINJECTION

5MG/ML ASTRA LAKEMEDEL AB SWEDEN

MARCAIN ADRENALIN SOLUTION FORINJECTION

N/A ASTRA LAKEMEDEL AB SWEDEN

MARCAIN ADRENALIN SOLUTION FORINJECTION

N/A ASTRA LAKEMEDEL AB SWEDEN

MARCAIN HEAVY SOLUTION FORINJECTION

5MG/ML ASTRA LAKEMEDEL AB SWEDEN

MARCAIN HEAVY SOLUTION FORINJECTION

5MG/ML ASTRAZENECA SVERIGEAB

SWEDEN

MARCAIN SPINAL SOLUTION FORINJECTION

5MG/ML ASTRA LAKEMEDEL AB SWEDEN

MAREVAN TABLET 3 MG GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

MAREVAN TABLETS 1 MG GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

MAREVAN TABLETS 5 MG GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

MARVELON TABLETS 0.15MG AND0.03MG

ORGANONLABORATORIES

UNITED KINGDOM

MARVELON 150/30 TABLETS TABLET N/A ORGANONLABORATORIES LIMITED

UNITED KINGDOM

MASTER-AID DISINFETTANTE CUTANEOUS SOLUTION 1G/100ML PIETRASANTA PHARMAS.R.L.

ITALY

MATERNA TAB TABLETS N/A WYETH-AYERSTCANADA INC.

CANADA

MAXEPA CAPSULE N/A SEVEN SEAS LIMITED UNITED KINGDOM

MAXIDEX OPHTHALMICSUSPENSION

1MG/ML S.A. ALCON-COUVREURN.V.

BELGIUM

MAXIDEX OPHTHALMIC OINTMENT 1MG/G S.A. ALCON-COUVREURN.V.

BELGIUM

MAXIMUM STRENGTH ANADINANALGESIC

TABLETS N/A WHITEHALLLABORATORIES LTD

UNITED KINGDOM

MAXIMUM STRENGTH ASPROCLEAR

EFFERVESCENT TABLET 500MG ROCHE PRODUCTSLIMITED

UNITED KINGDOM

EL618 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MAXIPIME POWDER FOR INJECTION 1000MG/3ML BRISTOL MYERS SQUIBBS.P.A

ITALY

MAXIPIME POWDER FOR INJECTION 500MG/1.5ML BRISTOL MYERS SQUIBBS.P.A

ITALY

MAXIPIME INJECTION 2G POWDER FOR INJECTION 2G BRISTOL-MYERS SQUIBBPHARMACEUTICALS LTD

ITALY

MAXITROL OPHTHALMICSUSPENSION

N/A S.A. ALCON-COUVREURN.V.

BELGIUM

MAXITROL OPHTHALMIC OINTMENT N/A S.A. ALCON-COUVREURN.V.

BELGIUM

MAXIVALET SUGAR COATEDTABLETS

10MG DEMO ABEE GREECE

MAXOLON TABLET 10MG SMITH KLINE BEECHAM PAKISTAN

MAXOLON TABLET 10MG SMITH KLINE &BEECHAM

PAKISTAN

MAXOLON INJECTION 5MG/ML SOLUTION FORINJECTION

0.5% W/V MONMOUTHPHARMACEUTICALS LTD

UNITED KINGDOM

MAXOLON PAEDIATRIC LIQUID ORAL SOLUTION 1MG/ML MONMOUTHPHARMACEUTICALS LTD

UNITED KINGDOM

MAXOLON TABLETS 10MG TABLET 10MG MONMOUTHPHARMACEUTICALS LTD

UNITED KINGDOM

MCP HEXAL 10 TABLET 10MG HEXAL AG GERMANY

MCP-RATIOPHARM SOLUTION 5.2MG/ML RATIOPHARM GMBH GERMANY

MCP-RATIOPHARM 10 SUPPOSITORY 10MG RATIOPHARM GMBH GERMANY

MCP-RATIOPHARM 10TABLETTEN

TABLET 10MG RATIOPHARM GMBH GERMANY

MDS NORDION S.A. TECHNETIUM(TC-99M) GEN

INTRAVENOUSINJECTION

NA BRISTOL=MYERS SQUIBBPHARMA BELGIUM S.A.

BELGIUM

MEASLES AND RUBELLA VIRUSVACCINE LIVE

POWDER FOR INJECTION N/A SERUM INSTITUTE OFINDIA LTD

INDIA

MEASLES MUMPS AND RUBELLALIVE ATTENUATED

FREEZE DRIED CAKE F/INJ

N/A M/S SERUM INSTITUTEOF INDIA LIMITED

INDIA

MEASLES VACCINE LIVEATTENUATED

POWDER FOR INJECTION 1000 CCID50 SERUM INSTITUTE OFINDIA LTD

INDIA

MEASLES, MUMPS AND RUBELLAVACCINE

POWDER FOR INJECTION N/A SERUM INSTITUTE OFINDIA LTD.

INDIA

MEBEVERINE TABLETS BP 135MG FILM COATED TABLETS 135MG GENERICS (UK) LIMITED UNITED KINGDOM

MECLON CREAM N/A FARMIGEA SPA ITALY

MECLON VAGINAL PESSARY N/A FARMIGEA SPA ITALY

MECLON «1000» VAGINAL DOUCHE,SOLUTION

N/A FARMIGEA SPA ITALY

MECLON «1000» VAGINAL CREAM N/A FARMIGEA SPA ITALY

MEDAXONE 1G POWDER FOR INJECTION 1G MEDOCHEMIE LTD CYPRUS

MEDAXONUM PWDR FOR INJ WITHSOLVENT

1G MEDOCHEMIE LTD. CYPRUS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 619

Trade Name Dosage Form Dose MA Holder Country

MEDAXONUM 500MG POWDER FOR INJ+SOLVENT

500MG/VIAL MEDOCHEMIE LTD CYPRUS

MEDIANOX CAPSULE 500MG DR.GROSSMANN AGPHARMACA

SWITZERLAND

MEDIATOR 150MG COATED TABLET 150MG LABORATOIRES SERVIER FRANCE

MEDICAID ANTISEPTIC CREAM CREAM 0.5%W/W EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

MEDIJEL GEL DENTAL GEL N/A D D D LIMITED UNITED KINGDOM

MEDIJEL PASTILLES LOZENGE N/A D D D LIMITED UNITED KINGDOM

MEDI-KEEL A THROAT LOZENGES LOZENGES N/A ADCOCK INGRAM LTD SOUTH AFRICA

MEDI-KEEL A THROAT SPRAY THROAT SPRAY 0.5G/100ML THE PREMIERPHARMACEUTICALCOMPANY LTD.

SOUTH AFRICA

MEDINOL OVER 6 PARACETAMOL ORAL SUSPENSION 250 MG CUPAL LIMITED UNITED KINGDOM

MEDINOL OVER 6 PARACETAMOLORAL SUSPEN.

ORAL SUSPENSION 250MG/5ML CUPAL LTD UNITED KINGDOM

MEDINOL UNDER 6PARACETAMOL

ORAL SUSPENSION 120 MG CUPAL LIMITED UNITED KINGDOM

MEDINOL UNDER 6PARACETAMOL ORAL SUSP BP

SUSPENSION 120MG/5ML CUPAL LTD. UNITED KINGDOM

MEDOBETA OINTMENT 0.1%W/W MEDOCHEMIE LTD CYPRUS

MEDOBETA CREAM 0.1G/100G MEDOCHEMIE LTD CYPRUS

MEDOCIPRIN TABLETS 500MG MEDOCHEMIE LTD. CYPRUS

MEDOCIPRIN TABLET 250MG MEDOCHEMIE LTD CYPRUS

MEDOCLAZIDE 80MG TABLET 80MG MEDOCHEMIE LTD CYPRUS

MEDOCLOR 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS

MEDOCRIPTINE 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS

MEDOCRIPTINE 2.5MG TABLET 2.5MG MEDOCHEMIE LTD CYPRUS

MEDOCYCLINE 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

MEDODERMONE CREAM 0.05% W/W MEDOCHEMIE LTD CYPRUS

MEDODERMONE OINTMENT 0.05% W/W MEDOCHEMIE LTD CYPRUS

MEDOFED SYRUP N/A MEDOCHEMIE LTD CYPRUS

MEDOFLUCON 150MG CAPSULE 150MG MEDOCHEMIE LTD CYPRUS

MEDOFLUCON 50MG CAPSULE 50MG MEDOCHEMIE LTD CYPRUS

MEDOFULVIN 125MG TABLET 125MG MEDOCHEMIE LTD CYPRUS

MEDOFULVIN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

MEDOLAX TABLET 12MG MEDOCHEMIE LTD CYPRUS

MEDOLEXIN POWDER FOR OR.SUSPENSION

125MG/5ML MEDOCHEMIE LTD CYPRUS

MEDOLEXIN 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

EL620 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MEDOLEXIN 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS

MEDOLEXIN FORTE 250MG/5ML POWDER FOR OR.SUSPENSION

250MG/5ML MEDOCHEMIE LTD CYPRUS

MEDOLIN 2MG/5ML SYRUP 2MG/5ML MEDOCHEMIE LTD CYPRUS

MEDOLIN 4MG TABLET 4MG MEDOCHEMIE LTD CYPRUS

MEDOMYCIN CAPSULE 100MG MEDOCHEMIE LTD CYPRUS

MEDONOL TABLET N/A MEDOCHEMIE LTD CYPRUS

MEDOPEN 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

MEDOPHENICOL 1G POWDER FOR INJECTION 1G MEDOCHEMIE LTD CYPRUS

MEDOPRAZOLE 20MG CAPSULE 20MG MEDOCHEMIE LTD CYPRUS

MEDOPRED 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

MEDOSTATIN TABLETS 20MG MEDOCHEMIE LTD. CYPRUS

MEDOVERINE 135MG FILMCOATED TABLETS

FILM COATED TABLETS 135MG MEDOCHEMIE LTD. —CYPRUS

CYPRUS

MEDOVIR 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

MEDOVIR 250MG POWDER FOR INJECTION 250MG MEDOCHEMIE LTD CYPRUS

MEDOVIR 5% W/W CREAM 5% W/W MEDOCHEMIE LTD CYPRUS

MEDOVIR 800MG TABLET 800MG MEDOCHEMIE LTD CYPRUS

MEDOZINE 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

MEFEMIC CAPSULE CAPSULE 250MG CAMDEN INDUSTRIES (M)SDN. BHD

MALAYSIA

MEFENAMIC ACID CAPSULES 250MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

MEFENAMIC ACID 500MGTABLETS

COATED TABLET 500MG SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

MEFENAMIC ACID BP CAPSULES250MG

CAPSULES 250MG SANOFI WINTHROP T/ASTERWIN MEDICINES

UNITED KINGDOM

MEFINTER FILM COATED CAPLET 500MG PT INTERBAT INDONESIA

MEFLIAM TABLET 250MG CIPLA LTD INDIA

MEGAPRESS TABLET 5MG GENEPHARM S.A. GREECE

MEGGEZONES LOZENGE N/A SCHERING-PLOUGHLIMITED

UNITED KINGDOM

MELIANE COATED TABLET N/A LABORATOIRESSCHERING

FRANCE

MELLERIL FILM COATED TABLETS 10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

MELLERIL FILM COATED TABLETS 25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

MELLERIL TABLET 10MG SANDOZ PAKISTAN

MELLERIL TABLET 25MG SANDOZ PAKISTAN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 621

Trade Name Dosage Form Dose MA Holder Country

MELLERIL FILM-COATED TABLETS 25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

MELLERIL FILM COATED TABLETS 100MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

MELLERIL COATED TABLETS 25MG NOVARTIS FARMA —PRODUTOSFARMACEUTICOS S.A

PORTUGAL

MELLERIL COATED TABLETS 10MG NOVARTIS FARMA —PRODUTOSFARMACEUTICOS S.A

PORTUGAL

MELLERIL 100MG TABLETS 100MG NOVARTIS PAKISTAN

MELLERIL 10MG TABLET 10MG NOVARTIS PAKISTAN

MELLERIL 25MG TABLET 25MG NOVARTIS PAKISTAN

MELOX TABLETS 7.5MG MEDOCHEMIE LTD. CYPRUS

MELOX TABLETS 15MG MEDOCHEMIE LTD. CYPRUS

MELOX SUPPOSITORIES 15MG MEDOCHEMIE LTD. CYPRUS

MELOX 15MG SUPPOSITORIES 15MG MEDOCHEMIE LTD CYPRUS

MENCEVAX (ACWY) POWDER FOR INJECTION N/A SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

MENCEVAX AC POWDER FOR INJECTION N/A SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

MENINGITEC SUSPENSION FORINJECTION

25MCG/0.5ML JOHN WYETH &BROTHER LTD

UNITED KINGDOM

MENINGITEC SUSPENSION FORINJECTION

25MCG JOHN WYETH &BROTHER LIMITED T/AWYETH VACCINES

UNITED KINGDOM

MENJUGATE POWDER FOR INJECTION N/A CHIRON S.P.A ITALY

MENOMUNE — A/C/Y/W-135 FREEZE-DRIEDPREPARATION

N/A AVENTIS PASTEUR, INC. UNITED STATES OFAMERICA

MENOMUNE-A/C/Y/W-135 COMBINED VACCINE N/A AVENTIS PASTEUR UNITED STATES OFAMERICA

MENOPHASE TABLET N/A MONSANTO PLC T/ASEARLE

UNITED KINGDOM

MENTHODEX COUGH MIXTURE ORAL SOLUTION N/A BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

MENTHOLATUM ANTISEPTICLOZENGE

LOZENGE N/A THE MENTHOLATUMCOMPANY LIMITED

UNITED KINGDOM

MENTHOLATUMBALM/MENTHOLATUM VAPOURRUB

OINTMENT N/A THE MENTHOLATUMCOMPANY LIMITED

UNITED KINGDOM

MENTHOLATUM DEEP HEAT RUB CREAM N/A THE MENTHOLATUMCOMPANY LIMITED

UNITED KINGDOM

MENTHOLATUM NASAL INHALER INHALATION SOLUTION N/A THE MENTHOLATUMCOMPANY LIMITED

UNITED KINGDOM

MENTHOLATUM/SUPERDRUGHEAT SPRAY

TOPICAL SPRAY N/A THE MENTHOLATUMCOMPANY LIMITED

UNITED KINGDOM

EL622 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MENZZA CREAM N/A HOE PHARMACEUTICALSSDN BHD

MALAYSIA

MEPHAMYCIN LACTAB 250MG MEPHA PHARMA AG SWITZERLAND

MEPHAMYCIN LACTAB 500MG MEPHA PHARMA AG SWITZERLAND

MEPHAMYCIN SUSPENSION 200MG/5ML MEPHA PHARMA AG SWITZERLAND

MEPHAQUIN LACTAB 250MG MEPHA PHARMA AG SWITZERLAND

MEPIVASTESIN INJECTION SOLUTION 30MG/ML ESPE DENTAL AG GERMANY

MERCILON TABLETS 150UG AND 20UG ORGANONLABORATORIES

UNITED KINGDOM

MERCILON TABLETS TABLET N/A ORGANONLABORATORIES LIMITED

UNITED KINGDOM

MERESA 200 TABLET 200MG DOLORGIET GMBH & CO.KG

GERMANY

MERESA 50 CAPSULE 50MG DOLORGIET GMBH & CO.KG

GERMANY

MEROCAINE LOZENGES N/A MARION MERRELL LTD UNITED KINGDOM

MEROCETS LOZENGES LOZENGE 1.4MG SETON PRODUCTSLIMITED

UNITED KINGDOM

MERONEM POWDER FOR INJECTION 500MG ZENECA LIMITED UNITED KINGDOM

MERONEM POWDER FOR INJECTION 1G ZENECA LIMITED UNITED KINGDOM

MERONEM POWDER FOR INJECTION 250MG/VIAL ZENECA LIMITED UNITED KINGDOM

MERONEM POWDER FOR IMINJECTION

500MG ZENECA LIMITED UNITED KINGDOM

MERONEM POWDER FOR INJECTION 1G ZENECA LIMITED UNITED KINGDOM

MERONEM POWDER FOR IVINJECTION

500MG ZENECA LIMITED UNITED KINGDOM

MESAGIN ENTERIC COATEDTABLETS

400MG KLEVA LTD GREECE

MESONEX TABLET 50MG ADELCO SA GREECE

MESONEX TABLETS 100MG ADELCOCHROMATOURGIAATHINON E.COLOCOTRONIS BROSS.A.

GREECE

MESTINON TABLET 60MG ROCHE PAKISTAN

MESTINON TABLETS 60MG TABLET 60MG ICN PHARMACEUTICALSLIMITED

UNITED KINGDOM

MESTINON TABLETS 60MG TABLET 60MG ICN PHARMACEUTICALSLIMITED

UNITED KINGDOM

METADOXIL TABLET 500MG LFD MANUFACTURINGLIMITED

THAILAND

META-IODOBENZYLGUANIDINE(131-I)

SOLUTION FORINJECTIONS

N/A NYCOMED AMERSHAMPLC

UNITED KINGDOM

META-IODOBENZYLGUANIDINE(131-I) FOR DIAGNOSTIC USE

SOLUTION FORINJECTIONS

18.5MB/ML AMERSHAM PLC UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 623

Trade Name Dosage Form Dose MA Holder Country

METALYSE POW AND SOLVENT F/ S.F/INJ

8,000 U BOEHRINGER INGELHEIMINTERNATIONAL GMBH

GERMANY

METALYSE POW AND SOLV F/SOL F/INJ

10,000 U BOEHRINGER INGELHEIMINTERNATIONAL GMBH

GERMANY

METFORMIN — BMS TABLETS 500MG GEA LTD DENMARK

METFORMIN DENK 850 FILM COATED TABLETS 850MG E.DENK OHG GERMANY

METFORMIN TABLET TABLET 500MG CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

METFORMIN TABLETS BP TABLETS 500MG INTASPHARMACEUTICALS LTD.

INDIA

METHADONE MIXTURE 1MG/1MLDTF

ORAL SOLUTION 1MG/1ML MACARTHYSLABORATORIES LIMITED

UNITED KINGDOM

METHADONE MIXTURE DTF 1MGIN 1ML

ORAL SOLUTION 0.1%W/V MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

METHADONE ORAL SOLN.1MG/1ML SUGAR FREE

ORAL SOLUTION 1MG/ML ROSEMONTPHARMACEUTICALS LTD

UNITED KINGDOM

METHOTREXATE INJECTION25MG/ML

SOLUTION FORINJECTION

25MG/ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

METHOTREXATE INJECTION5MG/2ML

SOLUTION FORINJECTION

5MG/2ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

METHOTREXATE INJECTION BPVIAL

SOLUTION FORINJECTION

50MG/2ML PHARMACIA (PERTH)PTY. LTD.

AUSTRALIA

METHOTREXATE INJECTION VIAL SOLUTION FORINJECTION

5MG/2ML F.H. FAULDING & CO.LTD (T/A DAVID BULLLABS)

AUSTRALIA

METHOTREXATE SODIUMTABLETS

TABLETS 2.5MG WYETH-AYERSTLABORATORIES

UNITED STATES OFAMERICA

METHOTREXATUM PHARMACIA SOLUTION FORINJECTION

25MG/1ML PHARMACIA NV/SA BELGIUM

METHYL SALICYLATE OINTMENTBP

OINTMENT 50%W/W THORNTON & ROSS LTD UNITED KINGDOM

METHYLDOPA BP 125MG TABLET 125MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

METHYLDOPA BP 250MG TABLET 250MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

METHYLDOPA BP 500MG TABLET 500MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

METHYLDOPA TABLETS FILM COATED TABLET 250MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

METHYLDOPA TABLETS BP125MG

TABLETS 125MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

METHYLDOPA TABLETS BP125MG

FILM COATED TABLET 125MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

METHYLDOPA TABLETS BP250MG

TABLETS 250MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

EL624 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

METHYLDOPA TABLETS BP500MG

TABLETS 500MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

METHYLDOPA TABLETS BP500MG

FILM COATED TABLET 500MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

METHYLENE BLUE INJECTION USP1%

SOLUTION FORINJECTION

1%W/V MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

METHYLENE BLUE INJECTION USP1% 5ML

SOLUTION FORINJECTION

1% W/V FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

METHYLPREDNISOLONE INJ. VIAL POWDER FOR INJECTION 1G/VIAL F.H. FAULDING & CO.LTD. (T/A DAVID BULLLABS)

AUSTRALIA

METHYLPREDNISOLONE MERCK POWDER FOR INJECTION 40MG MERCK GENERICS FRANCE

METHYLPREDNISOLONE SODIUMSUCCINATE

POWDER FOR INJECTION 500MG FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

METOCLOPRAMIDE INJECTION SOLUTION FORINJECTION

10MG/2ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

METOCLOPRAMIDE INJECTION BP10MG/2ML

SOLUTION FORINJECTION

10MG/2ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

METOCLOPRAMIDE INJECTIONUSP

SOLUTION FORINJECTION

10MG/2ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

METOLAR TABLETS 50MG CIPLA LIMITED INDIA

METOLAR 100 TABLETS 100MG CIPLA LIMITED INDIA

METOMIDE TABLET 10MG CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

METOPROLOL TARTARATETABLETS 100MG

TABLET 100MG GENERICS (UK) LIMITED UNITED KINGDOM

METOSYN CREAM 0.05% W/V ZENECA LIMITED UNITED KINGDOM

METOSYN FAPG CREAM CREAM 0.05% W / W BIOGLANLABORATORIES LTD

UNITED KINGDOM

METOSYN OINTMENT OINTMENT 0.05% W / W BIOGLANLABORARORIES LTD

UNITED KINGDOM

METRODIN HP 150IU POWDER FOR INJECTION 150IU HFSH/ML LABORATOIRES SERONOSA

ITALY

METRODIN HP 75IU INJECTABLEPREPARATION

75IU HFSH/ML LABORATOIRES SERONOSA

ITALY

METROGYL INJECTABLE SOLUTION 500MG/100ML COOPER S.A. GREECE

METROGYL 200 TABLET 200MG ALPHAPHARM PTYLIMITED

AUSTRALIA

METROGYL 400 TABLET 400MG ALPHAPHARM PTYLIMITED

AUSTRALIA

METROGYL INJECTION SOLUTION FORINJECTION

5MG/ML UNIQUEPHARMACEUTICALLABORATORIES

INDIA

METROLYL SUPPOSITORIES 500MG LAGAPPHARMACEUTICALSLIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 625

Trade Name Dosage Form Dose MA Holder Country

METROLYL SUPPOSITORY 1G LAGAPPHARMACEUTICALSLIMITED

UNITED KINGDOM

METRONIDAZOLE TABLETS 200MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

METRONIDAZOLE TABLETS 400MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

METRONIDAZOLE TABLET 200MG CAMDEN INDUSTRIES(M)SDN.BHD

MALAYSIA

METRONIDAZOLE TABLETS 200MG PHARMAMED LTD. MALTA

METRONIDAZOLE SOLUTION FORINJECTION

500MG/100ML PHARMAMEDPARENTERALS LTD.

MALTA

METRONIDAZOLE TABLET 200MG CIPLA LTD INDIA

METRONIDAZOLE INJECTION500MG/100ML

IV INFUSION SOLUTION 500MG/100ML B.BRAUN MELSUNGENAG

GERMANY

METRONIDAZOLE INJECTION, USP500MG

SOLUTION FORINJECTION

5MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

METRONIDAZOLE INTRAVENOUSINFUSION BP

INTRAVENOUS INFUSION 5MG/ML VYSALIPHARMACEUTICALSLIMITED

INDIA

METRONIDAZOLE MERCK SOLUTION F/INF. IN AVIAL

0.5G/100ML MERCK GENERIQUES FRANCE

METRONIDAZOLE TABLETS BPTRICHOGYL-200

TABLET 200MG TABLETS (INDIA) LIMITED INDIA

METROTOP GEL 0.8% W/V SETON PRODUCTS LTD UNITED KINGDOM

METVIX CREAM 160MG/G GALDERMA (UK) LIMITED UNITED KINGDOM

MEXETIL CAPSULES 200MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

MIACALCIC NASAL SPRAY 200IU NOVARTISFARMACEUTICA S.A

SPAIN

MIACALCIC NASAL SPRAY 200IU NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

MIACALCIC SOLUTION FORINJECTION

100IU/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

MIANSERIN TABLETS 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

MIANSERIN 20MG TABLETS NORTON HEALTHCARELIMITED

UNITED KINGDOM

MIANSERIN TABLETS 30MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

MIANSERIN TABLETS 10MG REMEDICA LTD. CYPRUS

MIANSERIN TABLETS BP 10MG TABLET 10MG GENERICS (UK) LIMITED UNITED KINGDOM

MIANSERIN TABLETS BP 30MG COATED TABLETS 30MG GENERICS (UK) LTD. UNITED KINGDOM

MIBG-131-D SOLUTION FORINJECTION

N/A CIS BIO INTERNATIONAL FRANCE

MIBG-131-T SOLUTION FORINJECTION

N/A CIS BIO INTERNATIONAL FRANCE

EL626 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MICANOL CREAM 1% CREAM 1% W / W BIOGLANLABORATORIES

UNITED KINGDOM

MICANOL CREAM 3% CREAM 3% W / W BIOGLANLABORATORIES LTD

UNITED KINGDOM

MICARDIS TABLET 40MG BOEHRINGER INGELHEIMINTERNATIONAL GMBH

GERMANY

MICARDIS TABLETS 80MG BOEHRINGER INGELHEININTERNATIONAL GMBH

GERMANY

MICARDIS PLUS TABLETS NA BOEHRINGER INGELHEIM EUROPEAN COMMUNITY

MICOGEL CREAM 2%W/W CIPLA LIMITED INDIA

MICONAL ECOBI CREAM 2% W/W FARMACEUTICI ECOBIS.A.S

ITALY

MICONAL ECOBI POWDER (TOPICAL) 2% W/W FARMACEUTICI ECOBISAS

ITALY

MICONAL ECOBI VAGINAL CREAM 2% W/W FARMACEUTICI ECOBIS.A.S

ITALY

MICONAL ECOBI VAGINAL OVULES 50MG FARMACEUTICI ECOBIS.A.S

ITALY

MICONAL ECOBI VAGINAL SOLUTION N/A FARMACEUTICI ECOBIS.A.S

ITALY

MICONAL ECOBI VAGINAL CAPSULES 1200MG FARMACEUTICI ECOBIS.A.S

ITALY

MICROCIDAL — 125 TABLET 125MG PHARMACARE LIMITED SOUTH AFRICA

MICROENEMA RECTAL ENEMA NA ATCO LABORATORIES(PVT) LTD

PAKISTAN

MICROGYNON COATED TABLET N/A SCHERING AG GERMANY

MICROGYNON COATED TABLET N/A SCHERING HEALTH CARELIMITED

UNITED KINGDOM

MICROLAX ENEMA, RECTALSOLUTION

N/A PHARMACIA SVERIGE AB SWEDEN

MICTRAL SACHETS GRANULES FOR ORALSOLN.

N/A SANOFI WINTHROPLIMITED

UNITED KINGDOM

MIDAZOLAM 2MG/ML INJECTION SOLUTION FORINJECTION

2MG/ML PHOENIX PHARMA LTD UNITED KINGDOM

MIDAZOLAM INJECTION BP SOLUTION FORINJECTION

5MG/ML CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

MIDAZOLAM INJECTION BP1MG/ML

SOLUTION FORINJECTION

1MG/ML RANBAXYLABORATORIES LTD

INDIA

MIDAZOLAM INJECTION BP5MG/ML

SOLUTION FORINJECTION

5MG/ML RANBAXYLABORATORIES LTD.

INDIA

MIDAZOLAM INJECTION BP5MG/ML

SOLUTION FORINJECTION

5MG/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

MIFLONIDE POWDER IN CAPSULESFOR INHALATION

200MCG NOVARTISFARMACEUTICA S.A

SPAIN

MIFLONIDE POWDER IN CAPSULESFOR INHALATION

400MCG NOVARTISFARMACEUTICA S.A

SPAIN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 627

Trade Name Dosage Form Dose MA Holder Country

MIFLONIDE 200 POWDER FORINHALATION

200MG NOVARTIS PHARMASCHWEIZ AG —SWITZERLAND

SWITZERLAND

MIFLONIDE 400 POWDER FORINHALTION

400MG NOVARTIS PHARMASCHWEIZ AG-SWITZERLAND

SWITZERLAND

MIGRALEVE COATED TABLET N/A UNICLIFFE LIMITED T/APFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

MIGRALEVE YELLOW COATED TABLET N/A UNICLIFFE LIMITED T/APFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

MIGRALGINE ORAL SOLUTION N/A LABORATOIRES MARTIN-JOHNSON & JOHNSON-MSD

FRANCE

MIGRALGINE CAPSULES N/A LABORATOIRES JEAN-PAUL MARTIN

FRANCE

MIGRANERTON CAPSULE N/A DOLORGIET GMBH & CO.KG

GERMANY

MIGRIL TABLETS N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

MIGRIL TABLETS N/A GLAXO WELLCOME PAKISTAN

MILITHIN HARD CAPSULES 300MG MINERVAPHARMACEUTICAL S.A.

GREECE

MILTEX SOLUTION FOR TOPICALUSE

600MG/10ML ASTA MEDICA AG GERMANY

MINADEX TONIC ORAL EMULSION N/A SEVEN SEAS LIMITED UNITED KINGDOM

MINESSE TABLETS NA JOHN WYETH &BROTHER LIMITED T/AWYETH LABORATORIES

IRELAND

MINIDIAB TABLETS 5MG PHARMACIA & UPJOHNS.P.A.

ITALY

MINIHEP SYRINGE N/A LEO LABORATORIESLIMITED

UNITED KINGDOM

MINIHEP SOLUTION FORINJECTION

25,000IU/ML LEO PHARMACETICALPRODUCTS

DENMARK

MINIMS ATROPINE SULPHATE 1% EYE DROPS 1%W/V CHAUVINPHARMACEUTICALSLIMITED

UNITED KINGDOM

MINIMS BENOXINATEHYDROCHLORIDE 0.4% W/V

EYE DROPS 0.4% W/V CHAUVINPHARMACEUTICALS LTD.

UNITED KINGDOM

MINIMS CYCLOPENTOLATEHYDROCHLORIDE

EYE DROPS 1% W/V CHAUVINPHARMACEUTICALS LTD.

UNITED KINGDOM

MINIMS FLUORESCEI SODIUM EYE DROPS 1% CHAUVINPHARMACEUTICALSLIMITED

UNITED KINGDOM

MINIMS METIPRANOLOL 0.3%W/V

EYE DROPS 0.3% W/V CHAUVINPHARMACEUTICALSLIMITED

UNITED KINGDOM

MINIMS PHENYLEPHRINEHYDROCHLORIDE

EYE DROPS 10% W/V CHAUVINPHARMACEUTICALS LTD.

UNITED KINGDOM

EL628 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MINIMS PHENYLEPHRINEHYDROCHLORIDE SOL.

EYE DROPS 2.5% W/V CHAUVINPHARMACEUTICALS LTD.

UNITED KINGDOM

MINIMS PILOCARPINE NITRATE2.0% W/V

EYE DROPS 2% W/V CHAUVINPHARMACEUTICALSLIMITED

UNITED KINGDOM

MINIMS TROPICAMIDE 0.5% W/V EYE DROPS 0.5% W/V CHAUVINPHARMACEUTICALS LTD.

UNITED KINGDOM

MINIMS TROPICAMIDE 1% W/V EYE DROPS 1% W/V CHAUVINPHARMACEUTICALS LTD.

UNITED KINGDOM

MINIRIN NASAL SPRAY 10MCG/DOSE FERRING AB SWEDEN

MINIRIN NASAL DROPS 0.1MG/ML FERRING AB SWEDEN

MINIRIN TABLETS 0.2MG FERRING AB SWEDEN

MINIRIN TABLETS 0.1MG FERRING AB SWEDEN

MINIRIN NASAL DROPS 0.1MG/ML FERRING AB SWEDEN

MINIRIN NASAL SPRAY 10MICROGRAMS/DO

FERRING AB SWEDEN

MINITRAN 10 TRANSDERMAL PATCH 10MG/24HOUR 3M HEALTH CARELIMITED

UNITED KINGDOM

MINITRAN 5, TRANSDERMAL PATCH 5MG/24HRS 3M HEALTH CARELIMITED

UNITED KINGDOM

MINOCIN CAPSULES 100MG LEDERLE LABORATORIES UNITED STATES OFAMERICA

MINOCIN CAPSULES 50MG LEDERLE LABORATORIES UNITED STATES OFAMERICA

MINOCYCLINE 100MG CAPSULES 100MG AEGIS LTD. CYPRUS

MINOCYCLINE 50MG CAPSULES 50MG AEGIS LTD. CYPRUS

MINOXIDIL TABLETS 10MG DANBURY PHARMACALINC.

UNITED STATES OFAMERICA

MINSK TABLET 10MG ANFARM HELLAS S.A. GREECE

MINULET COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY

MINULET TABLETS NA JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES

UNITED KINGDOM

MINULET TABLETS COATED TABLET N/A JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES— UK

UNITED KINGDOM

MIOCAMEN GRANULES FORSUSPENSION

20% W/W A.MENARINI INDUSTRIEFARMACEUTICHERIUNITE S.R.L.

ITALY

MIOCAMEN 600MG TABLET 600MG A.MENARINI INDUSTRIEFARMACEUTICHERIUNITE S.R.L.

ITALY

MIOCHOL-E INTRAOCULARSOLUTION

10MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

MIOCHOL-E 1:100 WITHELECTROLYTE DILUENT

INTRAOCULARSOLUTION

N/A CIBA VISIONCORPORATION

UNITED STATES OFAMERICA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 629

Trade Name Dosage Form Dose MA Holder Country

MIOREL TABLETS 10MG KLEVA LIMITED GREECE

MIOSTAT INTRAOCULARSOLUTION

0.01% W/V ALCON LABORATORIESINC.

UNITED STATES OFAMERICA

MIOSTAT INTRAOCULARSOLUTION

0.10 MG S.A ALCON COUVREURN.V

BELGIUM

MIOVISIN POWDER ANDSOLUTION FOR INJ

20MG FARMIGEA SPA ITALY

MIRENA 20 MICROG/24H INTRAUTERINE SYSTEM 52MG LEIRAS OY FINLAND

MISODOMIN TABLETS 40MG KLEVA LIMITED GREECE

MITOCIN POWDER FOR INJECTION 2MG KOREA UNITED PHARM.INC.

KOREA REPUBLIC

MITOCIN POWDER FOR INJECTION 10MG KOREA UNITED PHARM.INC.

KOREA REPUBLIC

MITOMYCIN POWDER FOR INJECTION 10MG/VIAL FAULDINGPHARMACEUTICALS PLC.,T/A DAVID BULLLABORATORIES

UNITED KINGDOM

MIVACRON INJECTION SOLUTION FORINJECTION

2MG/ML THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

MIVACRON INJECTION 2MG/ML SOLUTION FORINJECTION

2MG/ML THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

MIXTARD 30 HM 100IU/ML 10 MLVIAL

SUPENSION FORINJECTION

NA NOVO NORDISK DENMARK

MIXTARD 30 HM PENFILL100IU/ML 1.5ML

SOLUTION FORINJECTION

NA NOVO NORDISK A/S DENMARK

MIZOLLEN S.R. 10MG SR COATED TABLET 10MG LABORATOIRESSYNTHELABO

FRANCE

MMR-II-VAX VACCINE N/A MERCK SHARP & DOHME NETHERLANDS

MOBIC SUPPOSITORIES 7.5MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

MOBIC SOLUTION FORINJECTION

15MG/1.5ML BOEHRINGER INGELHEIMINTERNATIONAL GMBH

GERMANY

MOBIC 15MG TABLETS 15MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

MOBILAT CREAM N/A SANKYO PHARMA GMBH GERMANY

MOBILAT GEL N/A SANKYO PHARMA GMBH GERMANY

MOBILIS 20 CAPSULE 20MG ALPHAPHARM PTYLIMITED

AUSTRALIA

MOBILIS D-20 DISPERSIBLE TABLET 20MG ALPHAPHARM PTYLIMITED

AUSTRALIA

MOBILISIN CREAM N/A SANKYO PHARMA GMBH GERMANY

MODECATE SOLUTION FOR IMINJECTION

25MG/ML BRISTOL MYERS SQUIBBS.P.A.

ITALY

MODITEN TABLETS 1MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

MODOPAR 125 CAPSULE N/A F. HOFFMANN-LA ROCHELTD.

FRANCE

EL630 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MODOPAR 250 CAPSULE N/A F. HOFFMANN-LA ROCHELTD.

FRANCE

MODOPAR 62.5 CAPSULE N/A F. HOFFMANN-LA ROCHELTD.

FRANCE

MODOPAR LP 125 PROLONGED RELEASECAPSULE

N/A F. HOFFMANN-LA ROCHELTD.

FRANCE

MODURETIC TABLET N/A MERCK SHARP & DOHME PAKISTAN

MODURETIC TABLET N/A M.S.D. PAKISTAN

MODURETIC 5/50MG TABLET N/A MERCK SHARP & DOHMEB.V.

NETHERLANDS

MOGADON TABLETS 5MG TABLETS 5MG ICN PHARMACEUTICALSLTD

UNITED KINGDOM

MOISTUR-EYES «DRY EYE» DROPS EYE DROPS 0.3% W/V CO-PHARMA LIMITED UNITED KINGDOM

MOLCER EAR DROPS 5%W/V WALLACEMANUFACTURINGCHEMISTS LIMITED

UNITED KINGDOM

MOMENDOL COMPRESSA RIVESTITA 220MG AZ.CHIM. RIUNANGELINI FRANCESCOACRAF S.P.A

ITALY

MOMENDOL, GEL GEL NA AZ. CHIM. RIUN.ANGELINI FRANCESCOACRAF SPA — ITALY

ITALY

MOMENT 200, BLISTER 12 COMPRESSA RIVESTITA 200MG AZ. CHIM. RIUN.ANGELINI FRANCESCOACRAF SPA — ITALY

ITALY

MOMENT 200, BLISTER 24 COMPRESSA RIVESTITA 200MG AZ. CHIM. RIUN.ANGELINI FRANCESCOACRAF SPA — ITALY

ITALY

MOMENT 200, GOCCE ORALI GOCCE ORALI NA AZ. CHIM. RIUN.ANGELINI FRANCESCOACRAF SPA-ITALY

ITALY

MONO MACK 20MG TABLETS 20MG HEINRICH MACK NACHF GERMANY

MONO MACK 40MG TABLETS 40MG HEINRICH MACK NACHF GERMANY

MONO MACK DEPOT TABLETS W/SUST.ACTION

100MG HEINRICH MACK NACHF GERMANY

MONOCLOX 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

MONOLONG CAPSULES 60MG CTS CHEMICALINDUSTRIES LTD.

ISRAEL

MONOLONG 60MG CAPSULES CAPSULES 60MG CTS CHEMICALINDUSTRIES LTD

ISRAEL

MONOPARIN SOLUTION FORINJECTION

1000IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

MONOPARIN SOLUTION FORINJECTION

5000IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

MONOPARIN SOLUTION FORINJECTION

25000IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

MONOPARIN 1000IU/ML SOLUTION FORINJECTION

1000IU/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 631

Trade Name Dosage Form Dose MA Holder Country

MONOPARIN 25,000IU/ML SOLUTION FORINJECTION

25000 IU/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

MONOPARIN 5000IU/ML SOLUTION FORINJECTION

5000 IU/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

MONOPARIN CALCIUM SOLUTION FORINJECTION

25000IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

MONOPARIN-CA 25000 IU/ML SOLUTION FORINJECTION

25000 IU/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

MONOPAS TABLET 1G MACLEODSPHARMACEUTICALS LTD

INDIA

MONOPRIL (ELITEN) TABLETS 10MG BRISTOL MYERS SQUIBBS.P.A

ITALY

MONOPRIL (ELITEN) TABLETS 20MG BRISTOL MYERS SQUIBBS.P.A

ITALY

MONOSORDIL CONTROLLED RELEASECAPS

60MG ELPEN PHARM. CO. INC. GREECE

MONOSORDIL TABLET 20MG ELPEN S.A GREECE

MONOTARD HM 100 IU/ML 10MLVIAL

SUSPENSION FORINJECTION

NA NOVO NORDISK A/S DENMARK

MONO-TILDIEM SR 200MG SUSTAINED RELEASECAPSULE

200MG LABORATOIRESSYNTHELABO

FRANCE

MONO-TILDIEM SR 300MG SUSTAINED RELEASECAPSULE

300MG LABORATOIRESSYNTHELABO

FRANCE

MONOVAS 10MG TABLET TABLET 10MG MUSTAFA NEVZAT ILACSANAYII A.S.

TURKEY

MONOVENT ORAL SOLUTION 1.5MG/5ML LAGAPPHARMACEUTICALSLIMITED

UNITED KINGDOM

MORPHINE SULPHATE INJECTIONBP

SOLUTION FORINJECTION

15MG/ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

MORPHINE SULPHATE BP SOLUTION FORINJECTION

10 MG/ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

MORPHINE SULPHATE INJ. BP10MG IN 1ML

SOLUTION FORINJECTION

1%W/V MACARTHYSLABORATORIES LIMITED

UNITED KINGDOM

MORPHINE SULPHATE INJ. BP20MG IN 1ML

SOLUTION FORINJECTIONS

2%W/V PL 01883/6177R UNITED KINGDOM

MORPHINE SULPHATE INJ.BP15MG IN 1ML

SOLUTION FORINJECTIONS

1.5%W/V MACARTHYSLABORATORIES LIMITED

UNITED KINGDOM

MORPHINE SULPHATE INJECTION SOLUTION FORINJECTION

10MG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

MORPHINE SULPHATE INJECTION SOLUTION FORINJECTION

15MG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

MORPHINE SULPHATE INJECTIONBP

SOLUTION FORINJECTION

60MG/2ML EVANS MEDICAL LIMITED UNITED KINGDOM

MORPHINE SULPHATE INJECTIONBP

SOLUTION FORINJECTION

30MG/ML EVANS MEDICAL LIMITED UNITED KINGDOM

EL632 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MORPHINE SULPHATE INJECTIONBP

SOLUTION FORINJECTION

15MG/ML EVANS MEDICAL LIMITED UNITED KINGDOM

MORPHINE SULPHATE INJECTION,USP

SOLUTION FORINJECTION

15.45G/L ABBOTT LABORATORIES UNITED STATES OFAMERICA

MORPHINE SUPHATE INJECTIONBP

SOLUTION FORINJECTION

10MG/ML EVANS MEDICAL LIMITED UNITED KINGDOM

MOTHERWORT COMPOUNDTABLETS

COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

MOTILIUM TABLET 10MG JANSSEN PAKISTAN

MOTILIUM TABLET 10MG JANSSEN PAKISTAN

MOTILIUM SUSPENSION 1MG/ML JANSSEN PAKISTAN

MOTILIUM 10MG TABLET 10MG JANSSEN-CILAG N.V. BELGIUM

MOTILIUM 1MG/ML SUSPENSION 1MG/ML JANSSEN-CILAG N.V. BELGIUM

MOTILIUM BABY SUPPOSITORY 10MG JANSSEN-CILAG N.V. BELGIUM

MOTILIUM CHILDREN SUPPOSITORY 60MG JANSSEN-CILAG N.V. BELGIUM

MOTILIUM CHILDREN SUPPOSITORY 30MG JANSSEN-CILAG N.V. BELGIUM

MOTILIUM SYRUP SYRUP 1MG/ML JANSSEN PAKISTAN

MOTIPRESS TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

MOTIVAL TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

MOTIVAL TABLETS N/A BRISTOL MYERS SQUIBB EGYPT

MOVICOL POWDER FOR ORALSOLUTION

N/A LABORATOIRESNORGINE PHARMA

FRANCE

MOVICOL POWDER FOR ORALSOLUTION

N/A NORGINE LIMITED UNITED KINGDOM

MOXEN 250 CAPSULES 250MG AEGIS LTD. CYPRUS

MOXEN 500 CAPSULES 500MG AEGIS LTD. CYPRUS

MOXICLAV POWDER FOR OR.SUSPENSION

156.25MG/5ML MEDOCHEMIE LTD CYPRUS

MOXICLAV 375MG TABLET N/A MEDOCHEMIE LTD CYPRUS

MOXICLAV 625MG TABLET N/A MEDOCHEMIE LTD CYPRUS

MOXICLAV FORTE DRY POWDER FORSUSPENSION

312MG/5ML MEDOCHEMIE LTD. CYPRUS

MOXILEN POWDER FOR OR.SUSPENSION

125MG/5ML MEDOCHEMIE LTD CYPRUS

MOXILEN 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

MOXILEN 500MG POWDER FOR INJECTION 500MG MEDOCHEMIE LTD CYPRUS

MOXILEN 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS

MSI 10 MUNDIPHARMA SOLUTION FORINJECTION

10MG\ML MUNDIPHARMA GMBH GERMANY

MSI 20 MUNDIPHARMA SOLUTION FORINJECTION

20MG/ML MUNDIPHARMA GMBH GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 633

Trade Name Dosage Form Dose MA Holder Country

MST CONTINUS SUSPENSION30MG

GRANULES FOR ORALSOLUT.

N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

MST CONTINUS SUSPENSION100MG

ORAL SUSPENSION N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

MST CONTINUS SUSPENSION60MG

ORAL SUSPENSION N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

MST CONTINUS TABLETS 100MG MODIFIED RELEASETABLET

100MG NPP LABORATORIESLIMITED

UNITED KINGDOM

MST CONTINUS TABLETS 10MG MODIFIED RELEASETABLET

10MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

MST CONTINUS TABLETS 200MG MODIFIED RELEASETABLETS

200MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

MST CONTINUS TABLETS 30MG TABLETS 30MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

MST CONTINUS TABLETS 60MG MODIFIED RELEASETABLETS

60MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

MUCAINE SUSPENSION N/A JOHN WYETH &BROTHER LTD

UNITED KINGDOM

MUCAINE SUSPENSION ORAL SUSPENSION N/A JOHN WYETH &BROTHER LTD

UNITED KINGDOM

MUCICLAR SYRUP 0.3% W/V VECCHI & C PIAMS.A.P.A.

ITALY

MUCICLAR RETARD CAPSULE 75MG VECCHI & C PIAMS.A.P.A.

ITALY

MUCICLAR SIROP ADULTES SYRUP 5G/100ML PARKE-DAVIS AFRIQUEDE L'OUEST

SENEGAL

MUCICLAR SIROP ENFANTS ETNOURRISSONS

SYRUP 2G/100ML PARKE-DAVIS AFRIQUEDE L'OUEST

SENEGAL

MUCOBROXOL RETARD TABLETS 75MG MUNDIPHARMA GMBH GERMANY

MUCOBROXOL 60 EFFERVESCENT TABLETS 60MG MUNDIPHARMA GMBH GERMANY

MUCOBROXOL SYRUP SYRUP N/A MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

MUCOCIS SYRUP 5% W/V FONTEN FARMACEUTICIS.R.L.

ITALY

MUCODYNE PAEDIATRIC SYRUP125MG

ORAL SOLUTION 125MG/5ML MAY & BAKER LIMITED UNITED KINGDOM

MUCODYNE SYRUP 250MG/5ML ORAL SOLUTION 250MG/5ML MAY & BAKER LIMITED UNITED KINGDOM

MUCOFALK ORANGE GRANULES 3.25G DR. FALK PHARMAGMBH

GERMANY

MUCOFALK APPLE GRANULES 3.25G DR. FALK PHARMAGMBH

GERMANY

MUCOGEL SUSPENSION N/A PHARMAX LIMITED UNITED KINGDOM

MUCOPRONT CAPSULES 375MG HEINRICH MACK NACHF GERMANY

MUCOPRONT SYRUP SOLUTION 5G/100G HEINRICH MACK NACHF GERMANY

MUCOSOLVAN AMP 15MG/2ML BOEHRINGER INGELHEIMPHARMA KG

GERMANY

EL634 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MUCOSOLVAN LIQUID 15MG/5ML BOEHRINGER INGELHEIMPHARMA KG

GERMANY

MUCOSOLVAN LIQUID 30MG/5ML BOEHRINGER INGELHEIMKG

GERMANY

MUCOSOLVAN SOLUTION 15MG/2ML BOEHRINGER INGELHEIMPHARMA KG

GERMANY

MUCOSOLVAN SOLUTION 30MG/2ML BOEHRINGER INGELHEIMPHARMA KG

GERMANY

MUCOSOLVAN TABLETS 30MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

MUCOSOLVAN TABLETS 60MG BOEHRINGER INGELHEIMKG

GERMANY

MUCOSOLVAN L.A. CAPSULES 75MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

MUCOTREIS SYRUP 5G/100ML ECOBI FARMACEUTICIS.A.S.

ITALY

MUCOTREIS POWDER 0.3G/BAG ECOBI FARMACEUTICIS.A.S

ITALY

MUCOTREIS SYRUP 2G/100ML ECOBI FARMACEUTICIS.A.S

ITALY

MULTIPARIN SOLUTION FORINJECTION

1000IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

MULTIPARIN SOLUTION FORINJECTION

5000IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

MULTIPARIN SOLUTION FORINJECTION

25000IU/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

MULTIPARIN 1000IU/ML(5MLVIALS)

SOLUTION FORINJECTION

1000 IU/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

MULTIPARIN 25,000IU/ML SOLUTION FORINJECTION

25000 IU / ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

MULTIPARIN 5000IU/ML(IN 5MLVIALS)

SOLUTION FORINJECTION

5000 IU/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

MULTIVITAMIN COATED TABLETS NA PHARMAMED LTD. MALTA

MULTIVITAMIN DROPS ORAL DROPS N/A WARNER-LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

MULTIVITAMINS CAPSULE N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

MUMPSVAX VACCINE 5000 TCID50 MERCK SHARP & DOHME NETHERLANDS

MUPHORAN POWDER AND SOL FORIV INF

200MG/4ML LES LABORATOIRESSERVIER

FRANCE

MURINE PLUS EYE DROPS N/A ABBOTT PAKISTAN

MURINE TEARS LUBRICANT EYE DROPS N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

MURINE TEARS PLUS LUB.REDNESS RELIEVER

EYE DROPS N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

MUSE 1000 MICROGRAMS URETHRAL STICK 1000MCG VIVUS UK UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 635

Trade Name Dosage Form Dose MA Holder Country

MUSE 125 MICROGRAMS URETHRAL STICK 125 MCG VIVUS UK UNITED KINGDOM

MUSE 250 MICROGRAMS URETHRAL STICK 250 MCG VIVUS UK UNITED KINGDOM

MUSE 500 MICROGRAMS URETHRAL STICK 500MCG VIVUS UK UNITED KINGDOM

MXL CAPSULES 120MG MODIFIED RELEASECAPSULE

120MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

MXL CAPSULES 150MG MODIFIED RELEASECAPSULES

150MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

MXL CAPSULES 200MG MODIFIED RELEASECAPSULE

200MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

MXL CAPSULES 60MG MODIFIED RELEASECAPSULE

60MG NAPPPHARMACEUTICALSLIMITED

UNITED KINGDOM

MYCETIN LYOPHILISED EYE DROPS 25MG/VIAL FARMIGEA SPA ITALY

MYCIL ATHLETE'S FOOT SPRAY TOPICAL SPRAY 0.12%W/W CROOKES HEALTHCARELIMITED

UNITED KINGDOM

MYCIL OINTMENT OINTMENT N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

MYCIL POWDER TOPICAL POWDER N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

MYCOHEAL VAGINAL SUPPOSITORIES 200MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

MYCOHEAL CREAM NA DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

MYCOHEAL HC CREAM N/A DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

MYCOHEAL HC CREAM CREAM NA DAR AL DAWADEVELOPMENT ANDINVESTMENT

JORDAN

MYCOSPOR GEL 1% W/W BAYER VITAL GMBH &CO. KG

GERMANY

MYCOSPOR CREAM 0.01G/G BAYER VITAL GMBH &CO. KG

GERMANY

MYCOSPOR SOLUTION 0.01G/ML BAYER VITAL GMBH &CO. KG

GERMANY

MYCOSPOR CREAM N/A BAYER PAKISTAN

MYCOSPOR CREAM 0.01G/G BAYER PAKISTAN

MYCOSTATIN CREAM 100,000 UI / 1G E R SQUIBB & SONS LTD UNITED KINGDOM

MYCOSTATIN ORAL SUSPENSION 100,000 UI / ML SQUIBB INDUSTRIAFARMACEUTICA, S.A.

SPAIN

MYCOSTATIN OINTMENT 100,000 UI / G SQUIBB INDUSTRIAFARMACEUTICA, S.A.

SPAIN

MYCOSTATIN BABY OINTMENT OINTMENT 100,000UI / G SQUIBB INDUSTRIAFARMACEUTICA, S.A.

SPAIN

MYDRIATICUM EYE DROPS 5MG/ML CIBA VISION AG SWITZERLAND

EL636 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MYDRIATICUM 0.5% EYE DROPS 5.00MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

MYDRILATE EYE DROPS 1% INTRAPHARMLABORATORIES LIMITED

UNITED KINGDOM

MYDRILATE EYE DROPS 0,50% INTRAPHARMLABORATORIES LIMITED

UNITED KINGDOM

MYLERAN TABLETS 2MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

MYLERAN FILM COATED TABLET 2MG THE WELLCOMEFOUNDATION LTD T/AGLAXO WELLCOME

UNITED KINGDOM

MYLERAN FILM COATED TABLETS 2MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

MYLERAN TABLETS 2MG COATED TABLETS 2MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

MYOCRISIN INJECTION SOLUTION FORINJECTION

10% W/V JHC HEALTHCARE LTD UNITED KINGDOM

MYOCRISIN INJECTION 10% SOLUTION FORINJECTION

10% W/V JHC HEALTHCARELIMITED

IRELAND

MYOCRISIN INJECTION 4% SOLUTION FORINJECTION

4% W/V JHC HEALTHCARELIMITED

IRELAND

MYOCRISTIN INJECTION SOLUTION FORINJECTION

4% JHC HEALTHCARE LTD UNITED KINGDOM

MYOFLEX TABLET SEE REMARKS PRIMEPHARMACEUTICAL

MALAYSIA

MYOGESIC TABLETS N/A DAR AL DAWADEVELOPMENT NDINVESTMENT CO LIMITED

JORDAN

MYOVIEW POWDER FOR INJECTION 0.23MG/VIAL NYCOMED AMERSHAMPLC

UNITED KINGDOM

MYPRODOL CAPSULES NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

MYSOLINE TABLETS 250MG ZENECA LIMITED UNITED KINGDOM

NAAXIA EYE DROPS 38MG/ML CIBA VISION AG SWITZERLAND

NAAXIA EYE DROPS 38MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

NABUGESIC TABLETS 500MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

NACL 5% EYE DROPS 50MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

NACL 5% DISPERSA EYE DROPS 5% W/V CIBA VISION AG SWITZERLAND

NADITONE TABLETS 500MG KLEVA LTD. GREECE

NADRIFOR TABLETS 10MG KLEVA LTD GREECE

NAFORDYL TABLETS 20MG KLEVA LIMITED GREECE

NAFTAZOLINA NASAL DROPS, SPRAYSOLN.

0.2% W/V BRUSCHETTINI SRL ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 637

Trade Name Dosage Form Dose MA Holder Country

NAFTAZOLINA NASAL DROPS,SOLUTION

2G/100ML BRUSCHETTINI SRL ITALY

NALCROM CAPSULES 100MG CAPSULES 100MG FISONS LIMITED T/ARHONE-POULENC RORER

UNITED KINGDOM

NALCROM CAPSULES 100MG CAPSULE 100MG FISONS LTD T/A RHONE-POULENC RORER

UNITED KINGDOM

NALIDIX 500 TABLET 0.5G DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

NALIDIXIC ACID TABLETS 500MG PHARMAMED LTD. MALTA

NALIDIXIC ACID SUSPENSION ORAL SUSPENSION 300MG/5ML ROSEMONTPHARMACEUTICALSLIMITED

UNITED KINGDOM

NALION 0.5MG TABLET 0.5MG MEDOCHEMIE LTD CYPRUS

NALOXONE HYDROCHLORIDE SOLUTION FORINJECTION

0.4MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

NALOXONE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTION

0.02MG/ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

NALOXONE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTION

0.04MG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

NALOXONE HYDROCHLORIDEINJECTION

SOLUTION FORINJECTION

40MCG/2ML F.H. FAULDING & CO LTD(T/A DAVID BULL LABS)

AUSTRALIA

NALOXONE HYDROCHLORIDEINJECTION USP

SOLUTION FORINJECTION

400MICROGRAMS ANTIGENPHARMACEUTICALSLIMITED

IRELAND

NALOXONE HYDROCHLORIDEMINIJET

SOLUTION FORINJECTION

0.4MG/1ML INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

NALOXONE HYDROCHLORIDEMINJET

SOLUTION FORINJECTION

0.8MG/2ML INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

NALOXONE HYDROCHLORIDEUSP

SOLUTION FORINJECTION

20 MICROGRAM ANTIGENPHARMACEUTICALSLIMITED

IRELAND

NALOXONE HYDROCHLORIDRE SOLUTION FORINJECTION

0.02MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

NALOXONE INJ MINIJET SOLUTION FORINJECTION

0.8MG/2ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

NALOXONE INJECTION MINIJET SOLUTION FORINJECTION

0.4MG/1ML INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

NALOXONE MERCK 0.4MG/ML SOLUTION FOR INJ. 0.4MG/ML MERCK GENERIQUES FRANCE

NANOTIV POWDER FOR INJECTION 500IU (I+II) PHARMACIA & UPJOHNAB

SWEDEN

NANOTIV POWDER FOR INJECTION 1000IU(I+II) PHARMACIA & UPJOHNAB

SWEDEN

NANOTIV 1000IU POWDER ANDSOLVENT

POWDER AND SOLVENT N/A BIOVITRUM AB SWEDEN

EL638 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NANOTIV POWDER ANDSOLVENT

POWDER AND SOLVENT N/A BIOVITRUM AB SWEDEN

NAPHCON-A OPHTHALMIC SOLUTION N/A S.A. ALCON-COUVREURN.V.

BELGIUM

NAPROREX 250 TABLETS 250MG AEGIS LTD. CYPRUS

NAPROREX 375 TABLETS 375MG AEGIS LTD. CYPRUS

NAPROREX 500 TABLETS 500MG AEGIS LTD. CYPRUS

NAPROREX EC 250 TABLETS 250MG AEGIS LTD. CYPRUS

NAPROREX EC 375 TABLETS 375MG AEGIS LTD. CYPRUS

NAPROREX EC 500 TABLETS 500MG AEGIS LTD. CYPRUS

NAPROSYN 250 TABLET 250MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

NAPROSYN 500 TABLET 500MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

NAPROSYN EC 250MG TABLET 250MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

NAPROSYN EC 500MG TABLET 500MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

NAPROVAL CAPSULES 250MG LABORATORIO REIGJOFRE S.A

SPAIN

NAPROXEN TABLETS 250MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

NAPROXEN TABLETS 500MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

NAPROXEN BP 250MG TABLET 250MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

NAPROXEN BP 500MG TABLET 500MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

NAPROXEN TABLETS BP TABLETS 250MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

NAPROXEN TABLETS BP TABLETS 500MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

NAPROXEN-MEPHA 500 LACTAB 500MG MEPHA PHARMA AG SWITZERLAND

NARAMIG TABLETS 2.5MG COATED TABLET 2.5MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

NARCAN SOLUTION FORINJECTION

0.4MG/ML ENDOPHARMACEUTICALS INC.

UNITED STATES OFAMERICA

NARIXAN HARD GELATIN CAPSULESR.

120MG ALFA WASSERMANNS.P.A.

ITALY

NARIXAN CAPSULE 120MG ALFA WASSERMANNS.P.A.

ITALY

NAROP SOL. FOR INJ. AND IVINF.

2MG/ML ASTRA LAKEMEDEL AB SWEDEN

NAROP SOLUTION FORINJECTION

7.5MG/ML ASTRA LAKEMEDEL AB SWEDEN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 639

Trade Name Dosage Form Dose MA Holder Country

NAROP SOLUTION FORINJECTION

10MG/ML ASTRA LAKEMEDEL AB SWEDEN

NAROPIN SOL. FOR INJ. AND IVINF.

2MG/ML ASTRA LAKEMEDEL AB SWEDEN

NAROPIN SOLUTION FORINJECTION

7.5MG/ML ASTRA LAKEMEDEL AB SWEDEN

NAROPIN SOLUTION FORINJECTION

10MG/ML ASTRA LAKEMEDEL AB SWEDEN

NASACORT NASAL SPRAY 0.055% W/W MAY & BAKER LIMITEDT/A RHONE POULENCRORER

UNITED KINGDOM

NASACORT NASAL SPRAY 0.055% W/W MAY & BAKER LIMITEDT/A RHONE POULENCRORER

UNITED KINGDOM

NASACORT AQ NASAL SPRAY 55MCG/ACTUATION RHONE-POULENC RORERPHARMACEUTICALS INC.

UNITED STATES OFAMERICA

NASELIN NASAL SPRAY SOLUTION 0.05%W/V CIPLA LIMITED INDIA

NASENSPRAY E RATIOPHARM NASAL SPRAY SOLUTION 0.09MG/0.09ML RATIOPHARM GMBH GERMANY

NASENSPRAY K RATIOPHARM NASAL SPRAY SOLUTION 0.045MG/0.09ML RATIOPHARM GMBH GERMANY

NASONEX NASAL SPRAY 50MG/G SCHERING — PLOUGHS.A.

BELGIUM

NAT PHOS. NEW ERA NO.10 NATPHOS

TISSUE SALT TABLETSNO.10

NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NAT. MUR. NEW ERA BIOCHEMICNO.9

TISSUE SALT TABLET NO.9

NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NAT. SULPH. — NEW ERA NO.11NAT SULPH

TISSUE SALT TABLETSNO.11

NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NATRASLEEP FILM COATED TABLETS N/A PETER BLACKHEALTHCARE LIMITED

UNITED KINGDOM

NATRILIX FILM-COATED TABLET 2.5MG LES LABORATOIRESSERVIER

FRANCE

NATRILIX TABLETS 2.5MG SERVIER PAKISTAN

NATRILIX COATED TABLETS 2.5MG. SERVIER EGYPTINDUSTRIES LTD

EGYPT

NATRILIX 2.5MG TABLET 2.5MG SERVIER PAKISTAN

NATRILIX SR SUST. REL. COATEDTABLET

1.5MG LES LABORATOIRESSERVIER

FRANCE

NATRILIX SR TABLETS 1.5MG SERVIER PAKISTAN

NATRILIX SR TABLETS 1.5MG SERVIER PAKISTAN

NATRILIX SR COATED TABLET 1.5 MG SERVIER EGYPTINDUSTRIES LTD.

EGYPT

NATRILIX SR 1.5MG SUST. REL. COATEDTABLET

1.5MG LABORATOIRES SERVIER FRANCE

NAUTISOL 12.5MG LIQUID FOR INJECTION 12.5MG/2ML MEDOCHEMIE LTD CYPRUS

NAUTISOL 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

EL640 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NAVELBINE 10MG/1ML INJECTABLE SOLUTION 10MG/1ML PIERRE FABREMEDICAMENT

FRANCE

NAVELBINE 50MG/5ML INJECTABLE SOLUTION 50MG/5ML PIERRE FABREMEDICAMENT

FRANCE

NAVIDOXINE TABLET N/A U.C.B. S.A. BELGIUM

NAVOBAN CAPSULES 5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

NAVOBAN SOLUTION FORINJECTION

5MG/5ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

NEBILET 5MG TABLET 5MG MENARINIINTERNATIONALOPERATIONSLUXEMBOURG S.A.

GERMANY

NEGRAM 500MG TABLETS TABLET 500MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

NEGRAM SUSPENSION 6% W/V ORAL SUSPENSION 6% W/V SANOFI WINTHROPLIMITED

FRANCE

NELSONS CHILBLAIN CREAM CREAM 9%V/W A NELSONS ANDCOMPANY LTD

UNITED KINGDOM

NEO BOROCILLINA MOUTH WASH 24MG/100ML ALFA WASSERMANNS.P.A.

ITALY

NEO BOROCILLINA TABLETS N/A ALFA WASSERMANNS.P.A.

ITALY

NEO BOROCILLINA ORAL SPRAY 600MG/100ML ALFA WASSERMANNS.P.A.

ITALY

NEO BOROCILLINA TABLETS N/A ALFA WASSERMANNS.P.A.

ITALY

NEO BOROCILLINA «C» TABLET N/A ALFA WASSERMANNS.P.A.

ITALY

NEO BOROCILLINA «C» SENZ/ZUC TABLET N/A ALFA WASSERMANN ITALY

NEO BOROCILLINA C TABLET N/A ALFA WASSERMANNS.P.A.

ITALY

NEO BOROCILLINA SENZAZUCCHERO

TABLET N/A ALFA WASSERMANNS.P.A.

ITALY

NEO BOROCILLINA TOSSE SOLUTION FOR ORALUSE

N/A ALFA WASSERMANN ITALY

NEO BOROCILLINA TOSSE MOUTH SOLUBLETABLET

N/A ALFA WASSERMANNS.P.A.

ITALY

NEO-BUCOSIN LOZENGE N/A SYNPHARMA AG SWITZERLAND

NEODIPAR TABLETS TABLETS 500MG HOECHST PAKISTAN

NEO-MEDROL ACNE LOTION LOTION N/A PHARMACIA & UPJOHNINC.

CANADA

NEO-MERCAZOLE TABLET 20MG ROCHE PRODUCTSLIMITED

UNITED KINGDOM

NEO-MERCAZOLE TABLETS 5MG TABLET 5MG ROCHE PRODUCTELIMITED

UNITED KINGDOM

NEOMIGRAN NASAL SPRAY 4MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 641

Trade Name Dosage Form Dose MA Holder Country

NEO-NACLEX TABLET 5MG GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

NEORAL 25MG CAPSULE 25MG NOVARTIS PAKISTAN

NEORAL ORAL SOLUTION ORAL SOLUTION 100 MG/ML NOVARTISPHARMACEUTICALS UKLIMITED

IRELAND

NEORAL SOFT GELATIN CAPSULE SOFT GELATIN CAPSULES 25 MG NOVARTISPHARMACEUTICALS UKLIMITED

IRELAND

NEORECORMON 10000IU POWDER AND SOLVENTF. INJ.

10000IU/ML ROCHE REGISTRATIONLIMITED

UNITED KINGDOM

NEORECORMON 1000IU POWDER AND SOLVENTF. INJ.

1000IU/ML ROCHE REGISTRATIONLIMITED

UNITED KINGDOM

NEORECORMON 2000IU POWDER AND SOLVENTF. INJ.

2000IU/ML ROCHE REGISTRATIONLIMITED

UNITED KINGDOM

NEORECORMON 5000IU POWDER AND SOLVENTF. INJ.

5000IU/ML ROCHE REGISTRATIONLIMITED

UNITED KINGDOM

NEOSPECT KIT FOR RADIOPHARMPREP.

POWDER FOR INJECTION 47MCG/KIT NYCOMED IMAGING AS EUROPEAN COMMUNITY

NEOSTIGMINE SOLUTION FORINJECTION

0.5MG/1ML PHARMAMEDPARENTERALS LTD.

MALTA

NEOSTIGMINE INJECTION SOLUTION FORINJECTION

2.5MG/ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

NEOSTIGMINE INJECTION BP2.5.MG/ML

SOLUTION FORINJECTION

2.5.MG/ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

NEOSTIGMINE METHYLSULFATE SOLUTION FORINJECTION

1MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

NEOSTIGMINE METHYLSULPHATE SOLUTION FORINJECTION

2.5MG/ML PHOENIXPHARMACEUTICALS LTD.

UNITED KINGDOM

NEOSTIGMINE METHYLSULPHATEINJ INTRAMED

SOLUTION FORINJECTION

2.5MG/ML BODENE (PROPRIETARY)LIMITED T/A INTRAMED

SOUTH AFRICA

NEOSTIGMINEMETHYLSULPHATE-FRESENIUS

SOLUTION FORINJECTION

2.5MG/ML BODENE (PROPRIETARY)LIMITED T/A INTRAMED

REPUBLIC OF SOUTHAFRICA

NEOTIGASON CAPSULE 25MG ROCHE PHARMA(SCHWEIZ) LITD

SWITZERLAND

NEOTIGASON CAPSULE 10MG ROCHE PHARMA(SCHWEIZ) LTD

SWITZERLAND

NEOXENE VAGINAL OVULES 10MG FARMACEUTICI ECOBIS.A.S

ITALY

NEPHRIL TABLETS 1MG PFIZER LIMITED UNITED KINGDOM

NERISONE CREAM 1MG/G SCHERING AG GERMANY

NERISONE OINTMENT 1MG/G SCHERING AG GERMANY

NERISONE CREAM 0.1G/100G SCHERING SPA ITALY

NERISONE OINTMENT 0.1G/100G SCHERING SPA ITALY

NERISONE FATTY OINTMENT 0.1G/100G SCHERING SPA ITALY

EL642 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NERISONE C CREAM N/A SCHERING SPA ITALY

NERISONE C CREAM N/A SCHERING PAKISTAN

NERISONE CREAM CREAM 1MG/G SCHERING PAKISTAN

NETROMICIN SOLUTION FORINJECTIONS

150MG/1.5ML SCHERING-PLOUGHNV/SA

BELGIUM

NETROMICIN/NETROMYCIN SOLUTION FORINJECTION

50MG/2ML SCHERING-PLOUGH S.A. BELGIUM

NETROMYCIN SOLUTION FORINJECTION

50MG/2ML SCHERING-PLOUGHNV/SA

BELGIUM

NETROMYCIN SOLUTION FORINJECTION

50MG/ML SCHERING-PLOUGHLIMITED

UNITED KINGDOM

NETROMYCINE/NETROMYCIN SOLUTION FORINJECTION

150MG/1.5ML SCHERING-PLOUGH S.A. BELGIUM

NEUMEGA SUBCUTANEOUSINJECTION

5MG/ML GENERICS INSTITUTE,INC.

UNITED STATES OFAMERICA

NEUPOGEN VIAL 30MU AND 48MU ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

NEUROBAT SUGAR COATED TABLET N/A PT INTERBAT INDONESIA

NEUROLITE DRY SUBSTANCE ANDSOLVENT

N/A DUPONT PHARMA GMBH GERMANY

NEUROMULTIVIT FILM COATED TABLETS N/A LANNACHER HEILMITTELGES.M.B.H.

AUSTRIA

NEURONTIN 100MG CAPSULE 100MG PARKE-DAVIS GMBH GERMANY

NEURONTIN 300MG CAPSULE 300MG PARKE-DAVIS GMBH GERMANY

NEURONTIN 400MG CAPSULE 400MG PARKE-DAVIS GMBH GERMANY

NEURONTIN CAPSULES 100MG CAPSULE 100MG WARNER LAMBERT (UK)LIMITED T/A PARKEDAVIS

UNITED KINGDOM

NEURONTIN CAPSULES 100MG CAPSULE 100MG WARNER LAMBERT (UK)LTD. T/A PARKE DAVIS

UNITED KINGDOM

NEURONTIN CAPSULES 300MG CAPSULE 300MG WARNER LAMBERT (UK)LTD. T/A PARKE DAVIS

UNITED KINGDOM

NEURONTIN TABLETS 600MG FILM COATED TABLET 600MG WARNER LAMBERT (UK)LTD. T/A PARKE DAVIS

UNITED KINGDOM

NEURONTIN TABLETS 800MG FILM COATED TABLET 800MG WARNER LAMBERT (UK)LTD. T/A PARKE DAVIS

UNITED KINGDOM

NEURO-RATIOPHARM NFILMTABLETTEN

FILM COATED TABLET N/A RATIOPHARM GMBH GERMANY

NEURORUBIN LACTABS N/A MEPHA PHARMA AG SWITZERLAND

NEURORUBINE SOLUTION FORINJECTION

N/A MEPHA PHARMA AG SWITZERLAND

NEURORUBINE FORTE LACTAB N/A MEPHA PHARMA AG SWITZERLAND

NEUTROMAX 300MCG (30 M.U.I) SOLUTION FORINJECTION

300MCG INSTITUTO SIDUS S.A. ARGENTINA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 643

Trade Name Dosage Form Dose MA Holder Country

NEUTROMAX 480MCG (48 M.U.I) SOLUTION FORINJECTION

480MCG INSTITUTO SIDUS S.A. ARGENTINA

NEVIRAN TABLET 400MG FONTEN FARMACEUTICIS.R.L.

ITALY

NEVIRAN CREAM 5% W/W FONTEN FARMACEUTICIS.R.L.

ITALY

NEVPARIN SOLUTION FORINJECTION

25000IU/5ML MUSTAFA NEVZAT ILACSANAYII AS

TURKEY

NEW ERA COMBINATION A —SCIATICA

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION B (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION C (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION E SALT TABLETS N/A NEW ERA —LABORATORIES LTD —UK

UNITED KINGDOM

NEW ERA COMBINATION F (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION G (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION H (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION I (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION J (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION K TISSUE SALT TABLETS 6X NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION L (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION M (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION N (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION P (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION R (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATION S (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA COMBINATRION D (SEEREMARKS)

TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA NO.12 SILICA TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEW ERA NO.6 KALI. PHOS. TISSUE SALT TABLETS NA NEW ERALABORATORIES LIMITED

UNITED KINGDOM

NEXIUM GASTRO-RESISTANTTABLET

40MG HASSLE LAKEMEDEL AB SWEDEN

EL644 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NEXIUM GASTRO-RESISTANTTABLET

20MG HASSLE LAKEMEDEL AB SWEDEN

NICARDIA CAPSULES 10MG CAPSULES 10MG J.B. CHEMICALS &PHARMACEUTICALS LTD

INDIA

NICARDIA RETARD-10 FILM COATED TABLET 10MG J.B.CHEMICALS &PHARMACEUTICALS LTD

INDIA

NICARDIA RETARD-20 FILM COATED TABLET 20MG J.B.CHEMICALS &PHARMACEUTICALS LTD

INDIA

NICEF CAPSULES 250MG GALEN LIMITED UNITED KINGDOM

NICEF CAPSULES 500MG GALEN LIMITED UNITED KINGDOM

NICOBREVIN CAPSULE N/A NICOBREVIN UNITED KINGDOM

NICO-HEPATOCYN COATED TABLET N/A J.URIACH & CIA. S.A. SPAIN

NICORETTE MEDICATED CHEWINGGUM

2MG PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

NICORETTE MEDICATED CHEWINGGUM

4MG PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

NICORETTE TRANSDERMAL PATCHES 5MG/16 HOURS PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

NICORETTE TRANSDERMAL PATCHES 10MG/16HOURS PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

NICORETTE TRANSDERMAL PATCHES 15MG/16HOURS PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

NICORETTE MEDICATED CHEWINGGUM

2MG PHARMACIA SVERIGE AB SWEDEN

NICORETTE MEDICATED CHEWINGGUM

4MG PHARMACIA SVERIGE AB SWEDEN

NICORETTE TRANSDERMAL PATCH 5MG/16HOURS PHARMACIA SVERIGE AB SWEDEN

NICORETTE TRANSDERMAL PATCH 10MG/16HOURS PHARMACIA SVERIGE AB SWEDEN

NICORETTE TRANSDERMAL PATCH 15MG/16HOURS PHARMACIA SVERIGE AB SWEDEN

NICORETTE INHALATOR INHALATION VAPOUR 10MG/CARTRIDGE PHARMACIA LIMITED UNITED KINGDOM

NICORETTE INHALOR LIQUID FORINHALATION

10MG/CARTRIDGE PHARMACIA & UPJOHNLIMITED

UNITED KINGDOM

NICORETTE MINT MEDICATED CHEWINGGUM

2MG PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

NICORETTE MINT MEDICATED CHEWINGGUM

4MG PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

NICORETTE MINT MEDICATED CHEWINGGUM

2MG PHARMACIA SVERIGE AB SWEDEN

NICORETTE MINT MEDICATED CHEWINGGUM

4MG PHARMACIA SVERIGE AB SWEDEN

NICOTINAMIDE TABLET TABLET 50MG CAMDEN INDUSTRIES (M)SDN. BHD.

MALAYSIA

NICOTINELL TTS 10 TRANSDERMAL PATCH 17.5MG/PATCH NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 645

Trade Name Dosage Form Dose MA Holder Country

NICOTINELL TTS 20 TRANSDERMAL PATCH 35MG/ PATCH NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

NICOTINELL TTS 30 TRANSDERMAL PATCH 52.5MG/PATCH NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

NIDAGYL 200 TABLETS 200MG AEGIS LTD. CYPRUS

NIDAGYL 400 TABLETS 400MG AEGIS LTD. CYPRUS

NIDAGYL 500 CAPSULES 500MG AEGIS LTD. CYPRUS

NIDAGYL 500 TABLETS 500MG AEGIS LTD. CYPRUS

NIDOL TABLETS 100MG POLIPHARM CO. LTD. THAILAND

NIDOL SUSPENSION 1G/100ML POLIPHARM CO. LTD. THAILAND

NIFECARD CAPSULES 10MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

NIFECARD-10 CAPSULES 10MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

NIFEDI-DENK 10 RETARD RETARD TABLETS 10MG E.DENK OHG GERMANY

NIFEDI-DENK 20 RETARD RETARD TABLETS 20MG E.DENK OHG GERMANY

NIFEDIPINE CAPSULES 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

NIFEDIPINE CAPSULES 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

NIFEDIPINE CAPSULES 10MG GENERICS (UK) LIMITED UNITED KINGDOM

NIFEDIPINE SLOW RELEASE(NIFELAT RETARD)

SLOW RELEASE TABS 20MG CIPLA LIMITED INDIA

NIFELAT TABLETS 10MG REMEDICA LTD CYPRUS

NIFELAT-10 CAPSULES 10MG CIPLA LIMITED INDIA

NIFELAT-10 CAPSULE 10MG CIPLA LIMITED INDIA

NIFLUGEL 2.5 % PERCUTANEOUS GEL 2.5G/100G LABORATOIRES UPSA FRANCE

NIFLURIL 250MG CAPSULE 250MG LABORATOIRES UPSA FRANCE

NIFLURIL FOR CHILDREN 400MG SCORED SUPPOSITORY 0.4G LABORATOIRES UPSA FRANCE

NIFOPRESS RETARD TABLETS20MG

COATED TABLET 20MG GOLDSHIELD GROUP PLC UNITED KINGDOM

NIFTEN MODIFIED RELEASECAPSULES

N/A ZENECA LIMITED UNITED KINGDOM

NIGHT NURSE ORAL SOLUTION N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM COMSUMERHEALTHCARE

UNITED KINGDOM

NIGHT NURSE CAPSULES CAPSULE N/A BEECHAM GROUP PLCT/A SMITHKLINEBEECHAM CONSUMERHEALTHCARE

UNITED KINGDOM

NIGHTTIME COLD AND FLULIQUID CAPSULES

CAPSULE N/A STANLEYPHARMACEUTICALS LTD

CANADA

EL646 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NIMBEX SOLUTION FORINJECTION

2MG/ML THE WELLCOMEFOUNDATION

UNITED KINGDOM

NIMBEX SOLUTION FORINJECTION

5MG/ML THE WELLCOMEFOUNDATION

UNITED KINGDOM

NIMELID TABLETS 100MG GENEPHARM S.A. GREECE

NIMOTOP FILM-COATED TABLET 30MG BAYER VITAL GMBH &CO. KG

GERMANY

NIMOTOP INFUSION SOLUTION 0.01G/50ML BAYER VITAL GMBH &CO. KG

GERMANY

NIMTECH TABLETS 100MG MACLEODSPHARMACEUTICALS LTD

INDIA

NIPENT PWD. FOR SOL. FOR INJ/INF

10MG WARNER LAMBERT (UK)LIMITED

UNITED KINGDOM

NIPENT POWDER FOR IV INJ.SOLN.

10MG PARKE DAVIS SPA ITALY

NIPENT POWDER FOR SOLUTIONFOR INJECTION/INFUSION

10MG CYANAMID OF GREATBRITAIN LTD

UNITED KINGDOM

NIPIDOL 5MG TABLET TABLET 5MG BIOFARMA ILAC SAN.VETIC.A.S

TURKEY

NIPIDOL 5MG TABLET TABLET 5MG BIOFARMA ILLAC SAN.VETIC.A.S.

TURKEY

NIPODUR TABLET 150MG ANFARM HELLAS S.A. GREECE

NIPOGALIN POWDER FOR INJECTION 750MG ANFARM HELLAS S.A. GREECE

NISITA SALINE NASAL OINTMENT OINTMENT N/A KARL ENGELHARD GERMANY

NITRAZEPAM TABLETS 5MG GLAXO WELLCOMEPOZNAN S.A.

POLAND

NITRAZEPAM BP 5MG TABLET 500MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

NITRAZEPAM TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

NITRAZEPAM TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

NITREDON TABLETS 5MG REMEDICA LTD. CYPRUS

NITRODERM TTS TRANSDERMAL PATCHES 5MG NOVARTIS PHARMA ITALY

NITRODERM TTS TRANSDERMAL PATCHES 10MG NOVARTIS FARMA SPA ITALY

NITRODERM TTS 10 TRANSDERMAL PATCHES 50MG/20CM(2) NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

NITRODERM TTS 5 TRANSDERMAL PATCH 25MG/10CM(2) NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

NITROGLYCERIN INJECTION USP SOLUTION FORINJECTION

5MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

NITROLINGUAL SPRAY SOLUTION 0.4MG/SPRAY DOS G. POHL-BOSKAMPGMBH & CO

GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 647

Trade Name Dosage Form Dose MA Holder Country

NIVAQUINE TABLETS 200MG TABLET 200MG MAY & BAKER LIMITED(T/A RHONE-POULENCRORER)

UNITED KINGDOM

NIZORAL SHAMPOO 2% W/W JANSSEN-CILAG N.V. BELGIUM

NIZORAL CREAM 20MG/G JANSSEN-CILAG N.V. BELGIUM

NIZORAL 200MG TABLET 200MG JANSSEN-CILAG N.V. BELGIUM

NIZORAL 200MG TABLET 200MG JANSSEN-CILAG N.V. BELGIUM

NOCTAMID-1 TABLET 1MG SCHERING AG GERMANY

NOCTAMIDE 1MG TABLET 1MG LABORATOIRESSCHERING

FRANCE

NOCTYL FILM-COATED TABLETS 15MG LABORATOIRES MONOT FRANCE

NOLVADEX COATED TABLETS 10MG ZENECA LIMITED UNITED KINGDOM

NOLVADEX — D COATED TABLETS 20MG ZENECA LIMITED UNITED KINGDOM

NOLVADEX D (20MG TABLETS) COATED TABLET 20MG ZENECA LIMITED UNITED KINGDOM

NOLVADEX TABLETS 10MG COATED TABLET 10MG ZENECA LIMITED UNITED KINGDOM

NOOTROPIL FILM-COATED TABLET 800MG U.C.B. S.A. BELGIUM

NOOTROPIL INTRAVENOUS INFUSION 12G/60ML U.C.B. S.A. BELGIUM

NOOTROPIL INJECTABLE AMPOULE 1G/5ML U.C.B. S.A. BELGIUM

NOOTROPIL 20% DRINKABLE SOLUTION 20G/100ML U.C.B. S.A. BELGIUM

NOPIL SYRUP N/A MEPHA PHARMA AG SWITZERLAND

NOPIL TABLETS N/A MEPHA PHARMA AG SWITZERLAND

NOPIL FORTE TABLETS N/A MEPHA PHARMA AG SWITZERLAND

NOPRILAM PILL N/A LABORATORIOS BIAL —PORTELA & CA, S.A.

PORTUGAL

NOPRILAM COATED TABLET NA LABORATORIOS BIAL PORTUGAL

NOPRILAM COATED TABLETS NA LABORATOIRES BIAL PORTUGAL

NOPRILAM DT COVERED PILLS N/A LABORATORIOS BIAL —PORTELA & CA, S.A.

PORTUGAL

NOPRILAM DT COATED TABLET NA LABORATORIOS BIAL PORTUGAL

NOPRILAM DT COATED TABLETS NA LABORATOIRES BIAL PORTUGAL

NOPRILAM DT 400 POWDER FOR ORALSUSP.

N/A LABORATORIOS BIAL-PORTELA & CA S.A.

PORTUGAL

NOPRON TABLET 250MG VIANEX S.A GREECE

NORADRENALINE(NOREPINEPHRINE) 1:1000

SOLUTION FORINJECTION

0.2% W/V ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

NORADRENALINE AGUETTANT SOLUTION FORINFUSION

8MG/4ML LABORATOIREAGUETTANT

FRANCE

NORCURON 10MG POWDER FOR INJECTION 10MG/5ML ORGANON TEKNIKA B.V.(PART OF AKZO NOBEL)

UNITED KINGDOM

NORDETTE COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY

EL648 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NORDITRON SIMPLE XX SOLUTION FORINJECTION

5MG/1.5ML NOVO NORDISK A/S DENMARK

NORDITROPIN POWDER FOR INJECTION 4IU(1.3MG)/ML NOVO NORDISK A/S DENMARK

NORDITROPIN POWDER FOR INJECTION 12IU(4MG)/ML NOVO NORDISK A/S. DENMARK

NORDITROPIN PENSET POWDER FOR INJECTION 12 IU (4MG)/ML NOVO NORDISK A/S DENMARK

NORDITROPIN SIMPLEXX SOLUTION FORINJECTION

10MG/1.5ML NOVO NORDISK A/S DENMARK

NORDITROPIN SIMPLEXX10MG/1.5ML

SOLUTION FORINJECTION

10MG/1.5ML NOVO NORDISK A/S DENMARK

NORDITROPIN SIMPLEXX5MG/1.5ML

SOLUTION FORINJECTION

5MG/1.5ML NOVO NORDISK A/S DENMARK

NORFLEX ORPHENADRINECITRATE 100MG

TABLET 100MG 3M PHARMACEUTICALSPTY LTD

AUSTRALIA

NORGAGIL GRANULES N/A LABORATORIESNORGAN

FRANCE

NORGALAX UNIDOSE RECTAL GEL 0.12G NORGINE PHARMA FRANCE

NORGALAX ENEMA N/A NORGINE LIMITED UNITED KINGDOM

NORGESIC TABLET N/A 3M HEALTH CARELIMITED,

UNITED KINGDOM

NORMACOL GRANULES FOR ORALSOL.

N/A LABORATOIRESNORGINE PHARMA

FRANCE

NORMACOL GRANULES 62%W/W NORGINE LIMITED UNITED KINGDOM

NORMACOL INFANTS ENEMA UNIDOSE RECTALSOLUTION

N/A LABORATOIRESNORGINE PHARMA

FRANCE

NORMACOL LAVEMENT ADULTES UNIDOSE RECTALSOLUTION

N/A NORGINE PHARMA FRANCE

NORMACOL LAVEMENT ENFANTS UNIDOSE RECTALSOLUTION

N/A NORGINE PHARMA FRANCE

NORMACOL PLUS GRANULES N/A NORGINE LIMITED UNITED KINGDOM

NORMACOL PLUS ORAL GRANULES N/A NORGINE LIMITED UNITED KINGDOM

NORMAGLAUCON SOLUTION NA DR.GERHARD MANN,CHEM-PHARM. FABRIKGMBH

GERMANY

NORMIX COATED TABLETS 200MG ALFA WASSERMANNS.P.A.

ITALY

NORMIX GRANULES FOR ORALSUSP.

2G/100ML ALFA WASSERMANNS.P.A.

ITALY

NORMOLOSE TABLET 100MG ADELCO SA GREECE

NORMOLOSE TABLET 50MG ADELCO SA GREECE

NORMOLOSE TABLET 25MG ADELCO SA GREECE

NOROXIN TABLET 400MG MERCK SHARP & DOHME PAKISTAN

NOROXIN TABLET 400MG MERCK SHARP & DOHME PAKISTAN

NOROXIN 400MG TABLET 400MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 649

Trade Name Dosage Form Dose MA Holder Country

NORTRILEN TABLET 10MG H. LUNDBECK A/S DENMARK

NORTRILEN TABLET 25MG H. LUNDBECK A/S DENMARK

NORTUSSINE ADULTES SYRUP N/A NORGINE PHARMA FRANCE

NORTUSSINE INFANTS SYRUP N/A NORGINE PHARMA FRANCE

NORVIR ORAL SOLUTION 80MG/ML ABBOTT LABORATORIESLTD.

UNITED KINGDOM

NORVIR SOFT-GELATIN CAPSULES 100MG ABBOTT AG SWITZERLAND

NORVIR CAPSULES 100MG ABBOTT LABORATORIES UNITED STATES OFAMERICA

NORVIR SOFT CAPSULES 100MG ABBOTT LABORATORIESLTD.

UNITED KINGDOM

NOSKITO GEL N/A TRIMA ISRAELPHARMACEUTICALPRODUCTS LIMITED

ISRAEL

NO-SPA TABLET 40MG CHINOINPHARMACEUTICAL ANDCHEMICAL WORKS CO.LTD.

HUNGARY

NO-SPA SOLUTION FORINJECTION

40MG/2ML CHINOINPHARMACEUTICAL ANDCHEMICAL WORKS COLTD.

HUNGARY

NOTEN TABLET 50MG ALPHAPHARM PTYLIMITED

AUSTRALIA

NOTORIUM TABLET 1.5MG ADELCO-CHROMATOURGIAATHINON E.COLOCOTRONIS BROSSA

GREECE

NOTORIUM TABLET 3MG ADELCO SA GREECE

NOTORIUM TABLET 6MG ADELCO SA GREECE

NOVACLAV 375 TABLETS TABLETS NA CIPLA LTD. INDIA

NOVAGESIC-FLU 20 CAPSULE N/A SCANPHARM A.S. JAMAICA

NOVAL EYE DROPS SOLUTION 0.5% W/V DEMO ABEE GREECE

NOVAL EYE DROPS SOLUTION 0.25% W/V DEMO ABEE GREECE

NOVALGINE 500MG COATED TABLET 500MG LABORATOIRE HOECHST FRANCE

NOVAMILOR TAB TABLETS N/A NOVOPHARM LTD CANADA

NOVAMOXIN CAP 250MG CAPSULES 250MG NOVOPHARM LTD CANADA

NOVAMOXIN SUS 125MG/5ML POWDER FOR SOLUTION 125MG/5ML NOVOPHARM LIMITED CANADA

NOVAMOXIN SUS 250MG/5ML POWDER FOR SOLUTION 250MG/5ML NOVOPHARM LIMITED CANADA

NOVANTRONE SOLUTION FORINJECTION

20MG/10ML JOHN WYETH &BROTHER LTD.

UNITED KINGDOM

NOVANTRONE SOLUTION FOR IVINFUSION

20MG/10ML CYANAMID OF GREATBRITAIN LTD

UNITED KINGDOM

EL650 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NOVANTRONE INJECTION SOLUTION FORINJECTION/INFUSION

2MG/2ML CYANAMID OF GREATBRITAIN LTD

UNITED KINGDOM

NOVATAX-1000 POWDER FOR INJECTION 1G CIPLA LTD INDIA

NOVESIN 0.4% EYE DROPS 0.4% W/V CIBA VISION AG SWITZERLAND

NOVESIN 0.4% EYE DROPS 4.00MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

NOVOAMOXIN CAP 500MG CAPSULES 500MG NOVOPHARM LTD CANADA

NOVO-AMPICILLIN CAPSULE 500MG NOVOPHARM LIMITED CANADA

NOVO-ATENOL TAB 100MG TABLET 100MG NOVOPHARM LIMITED CANADA

NOVO-ATENOL TAB 50MG TABLET 50MG NOVOPHARM LIMITED CANADA

NOVO-AZT CAP 100MG CAPSULE 100MG NOVOPHARM LIMITED CANADA

NOVOBAN CAPSULE 5MG NOVARTIS SVERIGE AB SWEDEN

NOVOBAN SOLUTION FORINJECTION

1MG/1ML NOVARTIS SVERIGE AB SWEDEN

NOVO-BROMAZEPAM TABLET 6MG NOVOPHARM LIMITED CANADA

NOVO-BROMAZEPAM TAB 3MG TABLET 3MG NOVOPHARM LIMITED CANADA

NOVO-BUSPIRONE TAB 10MG TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-CAPTORIL TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-CAPTORIL TABLET 50MG NOVOPHARM LIMITED CANADA

NOVO-CEFACLOR CAPSULE 500MG NOVOPHARM LIMITED CANADA

NOVO-CEFACLOR CAP 250MG CAPSULE 250MG NOVOPHARM LIMITED CANADA

NOVO-CHLOROCAP CAP 250MG CAPSULES 250MG NOVOPHARM LTD CANADA

NOVO-CHOLAMINE — PWR POWDER FOR ORALSUSP.

4G NOVOPHARM LTD CANADA

NOVO-CLOPAMINE TABLETS —10MG

TABLETS 10MG NOVOPHARM LTD CANADA

NOVO-CLOPAMINE TABLETS —25MG

TABLETS 25MG NOVOPHARM LIMITED CANADA

NOVO-DIFENAC SUPPOSITORY 100MG NOVOPHARM LIMITED CANADA

NOVO-DIFENAC ENTERIC COATEDTABLET

50MG NOVOPHARM LIMITED CANADA

NOVO-DILTAZEM TAB 60MG TABLETS 60MG NOVOPHARM LTD CANADA

NOVO-DIPAM TABLET 5MG NOVOPHARM LIMITED CANADA

NOVO-DIPAM TABLET 2MG NOVOPHARM LIMITED CANADA

NOVO-DIPIRADOL TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-DOMPERIDONE TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-DOXEPIN CAP 25MG CAPSULES 25MG NOVOPHARM LTD CANADA

NOVO-DOXYLIN CAPSULE 100MG NOVOPHARM LIMITED CANADA

NOVO-FAMOTIDINE TABLET 20MG NOVOPHARM LIMITED CANADA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 651

Trade Name Dosage Form Dose MA Holder Country

NOVOFEM TABLETS NA NOVO NORDISK A/S DENMARK

NOVO-FLUPAM CAP 15MG CAPSULES 15MG NOVOPHARM LIMITED CANADA

NOVO-FLUPAM CAP 30MG CAPSULE 30MG NOVOPHARM LTD CANADA

NOVO-FLUVOXAMINE TABLET 50MG NOVOPHARM LIMITED CANADA

NOVO-FLUXOETINE CAPSULE 20MG NOVOPHARM LIMITED CANADA

NOVO-FOLIACID 5MG TABLETS 5MG NOVOPHARM LTD CANADA

NOVO-GLICLAZIDE TABLET 80MG NOVOPHARM LIMITED CANADA

NOVO-GLYBURIDE TABLETS 5MG NOVOPHARM LIMITED CANADA

NOVO-HEXIDYL 2MG TABLET 2MG NOVOPHARM LIMITED CANADA

NOVO-HYDROCORT CRM 1% CREAM 1% W / W NOVOPHARM LTD CANADA

NOVO-HYDROXYZIN CAPSULE 25MG NOVOPHARM LIMITED CANADA

NOVO-HYLAZIN TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-HYLAZIN 10MG USP TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-INDAPAMIDE TABLET 2.5MG NOVOPHARM LIMITED CANADA

NOVO-KETOTIFEN SYRUP 1MG/5ML NOVOPHARM LIMITED CANADA

NOVO-LEXIN CAP 250MG CAPSULES 250MG NOVOPHARM LTD CANADA

NOVO-LORAZEM TABLET 1MG NOVOPHARM LIMITED CANADA

NOVO-LORAZEM TABLET 2MG NOVOPHARM LIMITED CANADA

NOVO-MAPROTILINE TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-MAPROTILINE TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-MAPROTILINE — TAB50MG

TABLETS 50MG NOVOPHARM LTD CANADA

NOVO-METFORMIN TABLET 850MG NOVOPHARM LIMITED CANADA

NOVO-MEXILETINE CAPSULES 200MG NOVOPHARM LTD CANADA

NOVOMIX 30 FLEXPEN SUSPENSION FORINJECTION IN APRE-FILLED PEN

100U/ML NOVO NORDISK A/S EUROPEAN COMMUNITY

NOVOMIX 30 PENFILL SUSPENSION FORINJECTION INCARTRIDGES

100U/ML NOVO NORDISK A/S EUROPEAN COMMUNITY

NOVO-MOCLOBEMIDE TABLET 150MG NOVOPHARM LIMITED CANADA

NOVO-NADOLOL TABLET 40MG NOVOPHARM LIMITED CANADA

NOVO-NAPROX TAB 250MG TABLETS 250MG NOVOPHARM LTD CANADA

NOVO-NIFEDIN CAP 10MG CAPSULES 10MG NOVOPHARM LTD CANADA

NOVO-NORFLOXACIN TABLET 400MG NOVOPHARM LIMITED CANADA

NOVONORM TABLET 0.5MG NOVO NORDISK A/S UNITED KINGDOM

NOVONORM TABLET 1MG NOVO NORDISK A/S UNITED KINGDOM

NOVONORM TABLET 2MG NOVO NORDISK A/S UNITED KINGDOM

EL652 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NOVO-PERIDOL TABLET 5MG NOVOPHARM LIMITED CANADA

NOVO-PHENYTOIN CAPSULE 100MG NOVOPHARM LIMITED CANADA

NOVO-PRAMINE TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-PRAMINE TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-PRANOL TABLET 40MG NOVOPHARM LIMITED CANADA

NOVO-PRANOL TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-PRAZIN TABLET 1MG NOVOPHARM LIMITED CANADA

NOVO-PREDNISONE 5MG TABLETS 5MG NOVOPHARM LTD CANADA

NOVO-QUINIDIN 200MG TABLETS 200MG NOVOPHARM LTD CANADA

NOVO-RANIDINE TAB 150MG TABLETS 150MG NOVOPHARM LTD CANADA

NOVORAPID 100UNITS/ML SOLUTION FORINJECTION

100UNITS/ML NOVO NORDISK A/S UNITED KINGDOM

NOVORAPID NOVOLET100UNITS/ML

SOLUTION FORINJECTION

100UNITS/ML NOVO NORDISK A/S UNITED KINGDOM

NOVORAPID PENFILL100UNITS/ML

SOLUTION FORINJECTION

100UNITS/ML NOVO NORDISK A/S UNITED KINGDOM

NOVO-RIDAZINE 25MG TABLETS 25MG NOVOPHARM LTD CANADA

NOVOSEVEN POWDER FOR INJECTION 60KIU (1.2MG) NOVO NORDISK A/S UNITED KINGDOM

NOVOSEVEN POWDER FOR INJECTION 120KIU (2.4MG) EU/1/96/006/002 DENMARK

NOVOSEVEN POWDER FOR INJECTION 240KIU (4.8MG) NOVO NORDISK A/S DENMARK

NOVO-SOTALOL TABLET 80MG NOVOPHARM LIMITED CANADA

NOVO-SPIROTON TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-SUNDAC TAB 200MG TABLETS 200MG NOVOPHARM LTD CANADA

NOVO-TETRA 250MG CAPSULES 250MG NOVOPHARM LTD CANADA

NOVO-TRIFLUZINE TABLET 5MG NOVOPHARM LIMITED CANADA

NOVO-TRIPRAMINE TAB 25MG BP TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-TRIPRAMINE TAB 50MG TABLETS 50MG NOVOPHARM LTD CANADA

NOVO-TRIPTYN TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-TRIPTYN TAB 25MG TABLETS 25MG NOVOPHARM LTD CANADA

NUBAIN SOLUTION FORINJECTION

10MG/ML ENDOPHARMACEUTICALS INC.

UNITED STATES OFAMERICA

NUBAIN SOLUTION FORINJECTION

20MG/ML ENDOPHARMACEUTICALS INC

UNITED STATES OFAMERICA

NUELIN SA 175MG TABLETS MODIFIED RELEASETABLET

175MG 3M HEALTH CARELIMITED

UNITED KINGDOM

NUELIN SA 250MG TABLETS MODIFIED RELEASETABLET

250MG 3M HEALTH CARELIMITED

UNITED KINGDOM

NUELIN TABLETS TABLET 125MG 3M HEALTH CARELIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 653

Trade Name Dosage Form Dose MA Holder Country

NU-LAX FRUIT LAXATIVE SENNALEAF

BLOCK 80MG/G ORCHARDMANUFACTURING CO.PTY LTD

AUSTRALIA

NUMARK ANTI-DIARRHOEACAPSULES

CAPSULES 2MG GALPHARMHEALTHCARE LIMITED —UK

UNITED KINGDOM

NUMARK CHESTY COUGH ORAL LIQUID 100MG/5ML BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

NUMARK CHESTY COUGHEXPECTORANT

SYRUP N/A BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

NUMARK CHILDREN CHESTYCOUGH LINCTUS

ORAL SOLUTION N/A ROSEMONTPHARMACEUTICALSLIMITED

UNITED KINGDOM

NUMARK DECONGESTANTTABLETS WITH PARACETAMOL

FILM COATED TABLETS NA DEXCEL-PHARMALIMITED

UNITED KINGDOM

NUMARK NIGHT TIME SLEEP AID COATED TABLET 25MG NORMA CHEMICALS UNITED KINGDOM

NUPERCAINAL OINTMENT 1.1%W/W EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

NUROFEN COATED TABLET 200MG CROOKES HEALTHCARELIMITED

UNITED KINGDOM

NUROFEN 400 COATED TABLET 400MG CROOKES HEALTHCARELIMITED

UNITED KINGDOM

NUROFEN COLD AND FLU COATED TABLET N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

NUROFEN FOR CHILDREN SUGARFREE

ORAL SUSPENSION 100MG/5ML CROOKES HEALTHCARELIMITED

UNITED KINGDOM

NUROFEN PLUS COATED TABLET N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

NURSE HARVEY'S GRIPE MIXTURE ORAL SOLUTION N/A HARVEY SCRUTON LTD UNITED KINGDOM

NURSE SYKES POWDERS ORAL POWDER N/A ANGLIAN PHARMA PLC UNITED KINGDOM

NUSEALS TABLET 75MG LILLY PAKISTAN

NU-SEALS 300 GASTRO-RESISTANTTABLET

300MG ELI LILLY & COMPANYLIMITED

UNITED KINGDOM

NU-SEALS 75 COATED TABLET 75MG ELI LILLY & COMPANYLIMITED

UNITED KINGDOM

NUTRAMID TABLETS 10MG THE ACMELABORATORIES LTD —BANGLADESH

BANGLADESH

NUTRINEAL PD4 PERIT. DIALYSISSOL.

SOL F/INTRAPERITONEALADM

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

NUVELLE CONTINUOUS COATED TABLET N/A SCHERING HEALTH CARELTD

UNITED KINGDOM

NUVELLE TABLETS COATED TABLET N/A SCHERING HEALTH CARELTD

UNITED KINGDOM

NUVELLE TS TRANSDERMAL PATCH N/A ETHICALPHARMACEUTICALS (UK)LIMITED

UNITED KINGDOM

EL654 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NUVELLE TS TRANSDERMAL PATCH N/A SCHERING HEALTH CARELTD

UNITED KINGDOM

NYADERM CRM 100000 UNIT/GM CREAM 100000 UNIT TAROPHARMACEUTICALS INC.

CANADA

NYLAX WITH SENNA TABLET 7.5MG CROOKES HEALTHCARELIMITED

UNITED KINGDOM

NYLOL OPHTHALMIC GEL 1.00MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

NYOLOL 0.25% EYE DROPS 0.0125G/5ML CIBA VISIONOPHTHALMICS

FRANCE

NYOLOL 0.5% EYE DROPS 0.5% W/V CIBA VISIONOPHTHALMICS

FRANCE

NYOLOL 0.5% EYE DROPS 0.5MG/ML NOVARTISOPHTHALMICS SA

FRANCE

NYOLOL GEL OPHTHALMIC GEL 1MG/G CIBA VISION AG SWITZERLAND

NYSTATIN TABLETS 500,000UNITS TAROPHARMACEUTICALINDUSTRIES LTD.

ISRAEL

NYSTATIN READY MIXSUSPENSION

SUSPENSION 100,000U/ML TAROPHARMACEUTICALINDUSTRIES LTD.

ISRAEL

NYSTATIN TABLETS TABLET 500,000 UNITS TAROPHARMACEUTICALINDUSTRIES LTD

ISRAEL

NYSTATIN, READY MIXSUSPENSION

SUSPENSION 100,000 U/ML TAROPHARMACEUTICALINDUSTRIES LTD

ISRAEL

NYTOL TABLET 25MG STAFFORD-MILLERLIMITED

UNITED KINGDOM

NYTOL ONE-A-NIGHT TABLET 50 MG STAFFORD-MILLERLIMITED

UNITED KINGDOM

NYTOL ONE-A-NIGHT TABLET 50MG STAFFORD MILLERLIMITED

UNITED KINGDOM

NYTOL TABLETS TABLET 25MG STAFFORD MILLERLIMITED

UNITED KINGDOM

OCATANATE 500 POWDER AND SOLVENTFOR SOL.

500 I.U./VIAL OCTAPHARMA VERTRIEBVON PLASMADERIVATENGMBH

GERMANY

OCTAGRAM SOLUTION FORINFUSION

50MG/ML OCTAPHARMAPHARMAZEUTIKAPRODUKTIONSGES.M.B.H.

AUSTRIA

OCTANATE 1000 POWDER AND SOLVENTFOR SOL.

1000 I.U./VIAL OCTAPHARMA VERTRIEBVON PLASMADERIVATENGMBH

GERMANY

OCTANATE 250 POWDER AND SOLVENTFOR SOL.

250 I.U./VIAL OCTAPHARMA VERTRIEBVON PLASMADERIVATENGMBH

GERMANY

OCTOFENE 100MG SUPPOSITORY 100MG LABORATOIRES DEBAT FRANCE

OCTOFENE 200MG SUPPOSITORY 200MG LABORATOIRES DEBAT FRANCE

OCTOFENE 750MG SUPPOSITORY 750MG LABORATOIRES DEBAT FRANCE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 655

Trade Name Dosage Form Dose MA Holder Country

OCTONATIV-M POWDER FOR INJECTION 1000IU(I+II) PHARMACIA & UPJOHNAB

SWEDEN

OCTONATIV-M POWDER FOR INJECTION 250IU(I+II) PHARMACIA & UPJOHNAB

SWEDEN

OCTONATIV-M POWDER FOR INJECTION 500IU PHARMACIA & UPJOHNAB

SWEDEN

OCTONATIV-M POWDER AND SOLVENT 500 IU BIOVITRUM AB SWEDEN

OCTONATIV-M 1000IU POWDER AND SOLVENT (I+11) 1000IU BIOVITRUM AB SWEDEN

OCTORAX TABLETS 20MG DEM ABEE GREECE

OCTOSTIM SOLUTION FORINJECTION

15MCG/ML FERRING AB SWEDEN

OCUBRAX EYE DROPS N/A ALCON CUSI S.A. SPAIN

OCULOSAN EYE DROPS N/A CIBA VISION AG SWITZERLAND

OCULOSAN EYE DROPS NA NOVARTISOPHTHALMICS AG

SWITZERLAND

OCULOTECT EYE GEL 1000IU/G CIBA VISION AG SWITZERLAND

OCULOTECT EYE GEL 1000 UI /1G NOVARTISOPHTHALMICS AG

SWITZERLAND

OCULOTECT FLUID EYE DROPS 0.5G/10ML CIBA VISIONOPHTHALMICS

FRANCE

OCUTIM EYE DROPS SOLUTION 0.25% W/W CIPLA LIMITED INDIA

OCUTIM 0.5% EYE DROPS 0.5% W/V CIPLA LIMITED INDIA

ODASOL/GENEPHARM E.C. CAPSULES 20MG GENEPHARM S.A. GREECE

OESTRADIOL IMPLANT IMPLANT (SUB-CUTAN.USE)

25MG ORGANONLABORATORIES LIMITED

UNITED KINGDOM

OESTRADIOL IMPLANT IMPLANT (SUB-CUTAN.USE)

50MG ORGANONLABORATORIES LIMITED

UNITED KINGDOM

OESTRING VAGINAL DEVICE 7.5MCG/24HOURS PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

OESTRODOSE 0.06% GEL FORPERCUTANEOUS APPL

0.06% W/W LABORATOIRES BESINS-ISCOVESCO

FRANCE

OESTROFEMINAL 0.3MG CAPSULES 0.3MG HEINRICH MACK NACHF GERMANY

OESTROFEMINAL 0.6MG CAPSULES 0.6MG HEINRICH MACK NACHF GERMANY

OESTROFEMINAL 1.25MG CAPSULES 1.25MG HEINRICH MACK NACHF GERMANY

OFLOCET EAR DROPS 1.5MG/0.5ML LABORATOIRES AVENTIS FRANCE

OFLOCET 200MG TABLET 200MG LABORATOIRES AVENTIS FRANCE

OFLOCET 200MG/40ML SOLUTION FORINFUSION

200MG/40ML LABORATOIRESDIAMANT

FRANCE

OFLOMAC-100 TABLETS 100MG MACLEODSPHARMACEUTICALS LTD

INDIA

OFLOMAC-200 TABLET 200MG MACLEODSPHARMACEUTICALS LTD

INDIA

EL656 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

OFLOMAC-300 TABLETS 300MG MACLEODSPHARMACEUTICALS LTD

INDIA

OFLOMAC-400 TABLET 400MG MACLEODSPHARMACEUTICALS LTD

INDIA

OFLOX 0.3% OPHTHALMIC SOLUTION 0.3% W/V ALLERGANPHARMACEUTICALS(IRELAND) LTD., INC.

IRELAND

OFTALMIL EYE WASH N/A BRUSCHETTINI SRL ITALY

OFTALMIL EYE DROPS, SOLUTION N/A BRUSCHETTINI SRL ITALY

OILATUM SOAP 7.5% W/W STIEFEL LABORATORIES(UK) LTD

IRELAND

OILATUM CREAM CREAM NA STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

OILATUM EMOLLIENT TOPICAL SOLUTION 63.4% W/W STIEFEL LABORATORIES(UK) LTD

UNITED KINGDOM

OILATUM GEL TOPICAL SOLUTION 70% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

OILATUM JUNIOR TOPICAL SOLUTION 63.4% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

OILATUM JUNIOR FLARE-UP TOPICAL SOLUTION N/A STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

OILATUM PLUS TOPICAL SOLUTION N/A STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

OILY CREAM BP CREAM NO ACTIVE ING. ADAMS HEALTHCARELIMITED

UNITED KINGDOM

OILY PHENOL INJECTION 5% W/V SOLUTION FORINJECTION

5%W/V MACARTHYSLABORATORIES LTD

UNITED KINGDOM

OKA-AZITHROMYCIN TABLETS 250MG OKASA PHARMA PTVLTD.

INDIA

OKACIN EYE DROPS 3MG/ML CIBA VISION AG SWITZERLAND

OKACIN EYE DROPS NA NOVARTISOPHTHALMICS AG

SWITZERLAND

OKA-OMEPRAZOLE CAPSULES CAPSULE 20MG OKASA PHARMA PVT.LTD -INDIA

INDIA

OKAVIR TABLETS 150MG OKASA PHARMA LTD-INDIA

INDIA

OKI SOLUTION FOR ORALMUCOSA

N/A DOMPE' SPA ITALY

OLBAS BLACKCURRANTPASTILLES

LOZENGE NA GR LANE HEALTHPRODUCTS LIMITED

UNITED KINGDOM

OLBAS INHALER INHALATION LIQUID NA GR LANE HEALTHPRODUCTS

UNITED KINGDOM

OLBAS OIL TOPICAL SOLUTION N/A G R LANE HEALTHPRODUCTS

UNITED KINGDOM

OLBAS PASTILLES LOZENGE N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

OLBETAM CAPSULES 250MG PHARMACIA & UPJOHNS.P.A.

ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 657

Trade Name Dosage Form Dose MA Holder Country

OLFEN GEL 10MG/G MEPHA PHARMA AG SWITZERLAND

OLFEN ROLL-ON GEL 10MG/1G MEPHA PHARMA AG SWITZERLAND

OLFEN-100 RECTOCAPS 100MG MEPHA PHARMA AG SWITZERLAND

OLFEN-100 SR DEPOCAPS 100MG MEPHA PHARMA AG SWITZERLAND

OLFEN-25 LACTABS 25MG MEPHA PHARMA AG SWITZERLAND

OLFEN-50 LACTABS 50MG MEPHA PHARMA AG SWITZERLAND

OLFEN-75 SOLUTION FORINJECTION

N/A MEPHA PHARMA AG SWITZERLAND

OLFEN-75 RETARD DEPOTABS 75MG MEPHA PHARMA AG SWITZERLAND

OMEDAR TABLETS TABLETS 21 MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD.

JORDAN

OMEDOR ENTERIC COATEDTABLETS

20MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

OMNIC 0.4 MODIFIED RELEASECAPSULES

0.4MG YAMANOUCHI PHARMAB.V.

NETHERLANDS

OMNIPAQUE SOLUTION FORINJECTION

180MG I/ML NYCOMED UK LIMITED UNITED KINGDOM

OMNIPAQUE SOLUTION FORINJECTION

240MG I/ML NYCOMED U.K. LIMITED NORWAY

OMNIPAQUE SOLUTION FORINJECTIONS

300MG I/ML NYCOMED U.K. LIMITED NORWAY

OMNIPAQUE SOLUTION FORINJECTION

350MG I/ML NYCOMED U.K. LIMITED NORWAY

OMNIPAQUE SOLUTION FORINJECTION

140MG I/ML NYCOMED IMAGING AS NORWAY

OMNIPAQUE SOLUTION FORINJECTIONS

180MG I/ML NYCOMED IMAGING AS NORWAY

OMNIPAQUE SOLUTION FORINJECTION

240MG I/ML NYCOMED IMAGING AS NORWAY

OMNIPAQUE SOLUTION FORINJECTIONS

300MG I/ML NYCOMED IMAGING AS NORWAY

OMNIPAQUE SOLUTION FORINJECTIONS

350MG I/ML NYCOMED IMAGING AS NORWAY

OMNIPAQUE SOLUTION FORINJECTION

SEE REMARKS AMERSHAM HEALTH AS NORWAY

OMNIPAQUE SOLUTION FORINJECTION

SEE REMARKS AMERSHAM HEALTH AS NORWAY

OMNISCAN SOLUTION FORINJECTION

N/A NYCOMED IMAGING AS NORWAY

OMNISCAN SOLUTION FORINJECTION

287MG/1ML NYCOMED IMAGING AS NORWAY

OMNISCAN SOLUTION FORINJECTION

0.5 MMOL/ML AMERSHAM HEALTH AS NORWAY

OMNISCAN SOLUTION FORINJECTION

0.5MMOL/ML AMERSHAM HEALTH AS NORWAY

EL658 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

OMP TABLET (OMEPRAZOLE) TABLET 20MG CHONG KUN DANGPHARMACEUTICALCORP.

KOREA (DEM PEOPLE'SREP)

ONCASPAR SOLUTION FORINJECTION

750 IU/ML MEDAC GESELLSCHAFTFUR KLINISCHESPEZIALPRAPARATE MBH

GERMANY

ONCOVIN SOLUTION FORINJECTION

1MG/ML LABORATOIRES LILLYFRANCE

FRANCE

ONCTOSE HYDROCORTISONE CREAM N/A LABORATOIRES MONOT FRANCE

ONE ALPHA CAPSULE CAPSULE 0.25MCG LEO PAKISTAN

ONE-ALPHA CAPSULES 0.5MCG LEO PHARMACEUTICALPRODUCTS

DENMARK

ONE-ALPHA CAPSULES 0.25MCG LEO PHARMACEUTICALPRODUCTS

DENMARK

ONE-ALPHA CAPSULES 1MCG LEO PHARMACEUTICALPRODUCTS

DENMARK

ONE-ALPHA DROPS 2MCG/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

ONE-ALPHA SOLUTION FORINJECTION

2MCG/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

ONE-ALPHA CAPSULES CAPSULES 1MCG LEO PAKISTAN

ONKOVERTIN 40 IN 0.9%W/VSODIUM CHLORIDE

INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

ONKOVERTIN 40 IN 5% W/VGLUCOSE

INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

ONKOVERTIN 70 IN 0.9%W/VSODIUM CHLORIDE

INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

OPHTAMOLOL EYE DROPS 0.25% W/V DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

OPHTAMOLOL EYE DROPS 0.5% DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

OPRAZOLE TABLETS (14) 20MG HIKMAPHARMACEUTICALS

JORDAN

OPTAMID OPHTHALMIC DROPS NA PROGE FARMA SRL ITALY

OPTICROM AQUEOUS EYE DROPS EYE DROPS 2% W/V FISONS LIMITED UNITED KINGDOM

OPTICROM AQUEOUS EYE DROPS EYE DROPS 2%W/V FISONS LTD UNITED KINGDOM

OPTICROM EYE OINT. ORVISICROM EYE OINT.

EYE OINTMENT 4% W/V FISONS LIMITED UNITED KINGDOM

OPTICROM EYEOINTMENT/VISICROM

EYE OINTMENT 4%W/W FISONS LTD T/A RHONE-POULENC RORER

UNITED KINGDOM

OPTICROM-UD EYE DROPS INAMPOULES

20MG/ML RHONE-POULENC RORERAG

SWITZERLAND

OPTICROM-UD EYE DROPS INAMPOULES

N/A H. LUNBECK A/S DENMARK

OPTILAST EYE DROPS 0.05% W/V ASTA MEDICA LTD UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 659

Trade Name Dosage Form Dose MA Holder Country

OPTIPAX EAR DROPS SOLUTION N/A BIOCODEXLABORATORIES

FRANCE

OPTREX EYE DROPS EYE DROPS 13%V/V OPTREX LIMITED UNITED KINGDOM

OPTREX EYE LOTION EYE LOTION 13%V/V OPTREX LIMITED UNITED KINGDOM

OPTREX MEDICATED EYE DROPS EYE DROPS N/A OPTREX LIMITED UNITED KINGDOM

ORACORT PASTE PASTE 0.10% W/W TAROPHARMACEUTICALINDUSTRIES LTD

ISRAEL

ORAL POLIO VACCINE —TRIVALENT

SOLUTION FOR ORALADMI.

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

ORAL POLIOMYELITIS VACCINE DRINKABLE SOLUTION NA AVENTIS PASTEUR S.A. FRANCE

ORAL POLIOMYELITIS VACCINEPOLIO SABIN

SUSP. FOR ORALADMINIST.

N/A SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

ORALDENE SOLUTION 5MG/5ML WARNER LAMBERTCONSUMERHEALTHCARE

UNITED KINGDOM

ORAMORPH ORAL SOLUTION 10MG/5ML BOEHRINGER INGELHEIMLTD

UNITED KINGDOM

ORAP 1MG TABLET 1MG JANSSEN-CILAG N.V. BELGIUM

ORAP FORTE TABLET 4MG JANSSEN-CILAG N.V. BELGIUM

ORAP FORTE TABLETS 4MG JANSSEN CILAG NV BELGIUM

ORELOX 100MG TABLET 100MG LABORATOIRES AVENTIS FRANCE

ORELOX 40MG/5ML ENFANT ETNOURRISSON

GRANULES FOR ORALSUSPEN.

40MG/5ML LABORATOIRES AVENTIS FRANCE

ORFENAL 50 TABLETS 50MG REMEDICA LTD CYPRUS

ORIGINAL ANDREWS SALT EFFERVESCENT POWDER N/A SMITHKLINE BEECHAM(SWG) LIMITED

UNITED KINGDOM

ORIGINAL PHENSIC ASPIRIN TABLET N/A SEVEN SEAS LIMITED T/AMERCK CONSUMERHEALTH

UNITED KINGDOM

ORIMETEN TABLETS 250MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ORIMETEN TABLETS 250MG NOVARTIS FARMA SPA ITALY

ORLEPT TABLETS 200MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

OROCHOL BERNA DOUBLESACHET

LYOPHILISED VACC. FORREC

N/A SWISS SERUM ANDVACCINE INSTITUTE

SWITZERLAND

OROFAR WITH LIDOCAIN LOZENGES N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

OROFAR WITH LIDOCAIN SOLUTION N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

OROPRAM 10 MG, TABLETS TABLETS 10 MG OMEGA FARMA EHF. ICELAND

OROPRAM 20 MG, TABLETS TABLETS 20 MG OMEGA FARMA EHF. ICELAND

OROPRAM 40 MG, TABLETS TABLETS 40 MG OMEGA FARMA EHF. ICELAND

EL660 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

OROVITE 7 GRANULES FOR ORALSUSP.

N/A SETON HEALTHCAREGROUP PLC

UNITED KINGDOM

OROVITE 7 GRANULES FOR ORALSUSP.

N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

OROVITE TABLETS TABLET N/A SETON HEALTHCAREGROUP PLC

UNITED KINGDOM

OROVITE TABLETS TABLETS N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

ORREPASTE PASTE N/A HOE PHARMACEUTICALSSDN.BHD.

MALAYSIA

ORREPASTE, CREAM CREAM 0.1% W/W HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

ORSINON TABLET 500MG REKAHPHARMACEUTICALINDUSTRY LTD

ISRAEL

ORTHOCLONE OKT 3 SOLUTION FORINJECTION

5MG/5ML JANSSEN-CILAG AG SWITZERLAND

ORTHO-GYNEST VAGINAL CREAM 0.1MG/G JANSSEN-CILAG AG SWITZERLAND

ORTHO-GYNEST VAGINAL OVULE 0.5MG JANSSEN-CILAG AG SWITZERLAND

ORUVAIL 100 MODIFIED RELEASECAPSULE

100MG HAWGREEN LIMITED IRELAND

ORUVAIL 200 MODIFIED RELEASECAPSULE

200MG HAWGREEN LIMITED IRELAND

OSANGIN TABLETS N/A MARCO ANTONETTOSPA

ITALY

OSMOFUNDIN 10% INFUSION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

OSMOFUNDIN 15% N INFUSION SOLUTION 15% W/V B.BRAUN MELSUNGENAG

GERMANY

OSMOFUNDIN 15% N INFUSION SOLUTION 15% W/V B.BRAUN MELSNGEN AG GERMANY

OSMOGEL GEL F/LOCALAPPLICATION

N/A LABORATOIRES MONOT FRANCE

OSPAMOX TABLET 500MG BIOCHEMIE GMBH AUSTRIA

OSPEXIN TABLET 500MG BIOCHEMIE GMBH AUSTRIA

OSSIN RETARDDRAGEES TABLET 40MG GRUNENTHAL GMBH GERMANY

OSTEDRON CAPSULES 400MG KLEVA LIMITED GREECE

OSTEOCALCIN SOLUTION FORINJECTION

100 IU DOTT. A. TOSIFARMACEUTICI S.A.S.

ITALY

OTOMIZE EAR SPRAY METERED AEROSOL N/A STAFFORD-MILLERLIMITED

UNITED KINGDOM

OTOPAIN EAR DROPS N/A PT INTERBAT INDONESIA

OTORALGYL WITHPHENYLEPHRINE

EAR SPRAY N/A LABORATOIRES MARTIN-JOHNSON & JOHNSON-MSD

FRANCE

OTOSPORIN EAR DROPS N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 661

Trade Name Dosage Form Dose MA Holder Country

OTOSPORIN EAR DROPS NA THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

OTOSPORIN DROPS EAR DROPS NA GLAXOWELLCOME PAKISTAN

OTRINOL PROLONGED RELEASECAPSULE

120MG NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

OTRISAL BABY NASAL SPRAY N/A NOVARTIS CONSUMERHEALTH — GEBROGMBH

AUSTRIA

OTRIVIN NASAL SPRAY 0.1% W/V NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

OTRIVIN SOLUTION 0.05% W/V NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

OTRIVIN SOLUTION 0.1% W/V NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

OTRIVIN GEL 0.1% W/W NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

OTRIVIN NEBULISING SOLUTION N/A CIBA PAKISTAN

OTRIVIN NASAL DROPS 1MG/ML NOVARTIS CONSUMERHEALTH SCHWEIZ AG

SWITZERLAND

OTRIVIN 0.05% NASAL DROPS 0.5MG/ML NOVARTIS CONSUMERHEALTH SCHWEIZ AG

SWITZERLAND

OTRIVIN 0.1% NASAL DROPS INNEBULISER

1MG/ML NOVARTIS CONSUMERHEALTH SCHWEIZ AG

SWITZERLAND

OTRIVIN 0.1% NASAL GEL 0.1%W/W NOVARTIS CONSUMERHEALTH SCHWEIZ AG

SWITZERLAND

OTRIVIN 0.1% METERED DOSE SPRAY 1MG/1ML NOVARTIS CONSUMERHEALTH SCHWEIZ AG

SWITZERLAND

OVRAL COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY

OWS (DICLOFENAC SODIUM) SOLUTION FORINJECTION

75MG/2ML UNIMEDPHARMACEUTICALS INC.

KOREA REPUBLIC

OXACID 200 CAPSULES 200MG AEGIS LTD. CYPRUS

OXACTIN CAPSULES 20MG SCHEINPHARMACEUTICAL UKLIMITED

UNITED KINGDOM

OXILAN — 300 SOLUTION FORINJECTION

300MG IODINE/ML COOK IMAGINGCORPORATION

UNITED STATES OFAMERICA

OXILAN — 350 SOLUTION FORINJECTION

350MG IODINE/ML COOK IMAGINGCORPORATION

UNITED STATES OFAMERICA

OXIS TURBUHALER INHALATION POWDER 6MCG/AC ASTRAPHARMACEUTICALSLIMITED

UNITED KINGDOM

OXIS TURBUHALER INHALATION POWDER 12MCG/AC ASTRAPHARMACEUTICALSLIMITED

UNITED KINGDOM

OXISEPT SOL.EXT.U.S. 7.5% 75MG DEMO S.A. GREECE

OXISEPT 10% EXTERNAL SOLUTION 10% DEMO SA GREECE

OXSORALEN LOTION 1% W/V ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

EL662 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

OXSORALEN CAPSULE 10MG ICN PHARMACEUTICALS,INC.

UNITED STATES OFAMERICA

OXSORALEN CAPSULES 10MG ICN PHARMACEUTICALS UNITED STATES OFAMERICA

OXSORALEN LOTION 1% V/V ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

OXSORALEN CAPSULES 10MG ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

OXYBUTYNIN HYDROCHLORIDE TABLET 5MG GENERICS (UK) LIMITED UNITED KINGDOM

OXYBUTYNIN HYDROCHLORIDE TABLETS 5MG GENERICS (UK) LIMITED UNITED KINGDOM

OXYBUTYNIN HYDROCHLORIDETABLETS 5MG

TABLET 5MG SANOFI WINTHROP LTD UNITED KINGDOM

OXYTETRACYCLINE TABLETS 250MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

OXYTETRACYCLINE TABLETS 250MG PHARMAMED LTD. MALTA

OXYTETRACYCLINE 100MG TABLET 100MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

OXYTETRACYCLINE BP 250MG TABLET 250MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

OXYTETRACYCLINE BP 50MG TABLET 50MG SUSSEXPHARMACEUTICALLIMETED

UNITED KINGDOM

OZEPAL TABLETS 5MG DEMO ABEE GREECE

OZOPULMIN SUPPOSITORIES 40MG GEYMONAT SPA ITALY

OZOPULMIN SUPPOSITORIES 80MG GEYMONAT SPA ITALY

OZOPULMIN SUPPOSITORIES 160MG GEYMONAT SPA ITALY

OZOPULMIN GEL N/A GEYMONAT SPA ITALY

OZOPULMIN SYRUP N/A GEYMONAT SPA ITALY

OZOTHINE SYRUP 0.24G/100ML SOCIETE PHOCEAL FRANCE

PABRINEX INTRAMUSCULARHIGH POTENCY

SOLUTION FORINJECTION

N/A LINK PHARMACEUTICALSLIMITED

UNITED KINGDOM

PABRINEX INTRAVENOUS HIGHPOTENCY

SOLUTION FORINJECTION

N/A LINK PHARMACEUTICALSLIMITED

UNITED KINGDOM

PACIFENE TABLETS 200MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PACIFENE MAXIMUM STRENGTH TABLETS 400MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PACIMOL(PARACETAMOLTABLETS BP)

TABLET 500MG IPCA LABORATORIESLIMITED

INDIA

PAEDIATRIC PARACETAMOLORAL SOLUTION BP

ORAL SOLUTION 120MG WILLIAM RANSOM &SON PLC

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 663

Trade Name Dosage Form Dose MA Holder Country

PALDESIC (PARACETAMOLSUSPEN. 120MG/5ML)

ORAL SUSPENSION 120MG/5ML ROSEMONTPHARMACEUTICALSLIMITED

UNITED KINGDOM

PALUDRINE TABLETS 100MG ZENECA LIMITED UNITED KINGDOM

PALUDRINE 100MG TABLET 100MG ASTRAZENECA UKLIMITED

UNITED KINGDOM

PAMECIL POWDER FOR OR.SUSPENSION

125MG/5ML MEDOCHEMIE LTD CYPRUS

PAMECIL 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

PAMECIL 250MG POWDER FOR INJECTION 250MG MEDOCHEMIE LTD CYPRUS

PAMOCIL CAPSULES 1G FARMA UNO SRL ITALY

PAMOL SUSPENSION 120MG/5ML DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LIMITED

JORDAN

PANADOL SUPPOSITORY 500MG SANOFI WINTHROP —PRODUCTOSFARMACEUTICOS, LDA.

PORTUGAL

PANADOL SUPPOSITORY 250MG SANOFI WINTHROP —PRODUCTOSFARMACEUTICOS, LDA.

FRANCE

PANADOL SUPPOSITORY 125MG SANOFI WINTHROP —PRODUCTOSFARMACEUTICOS, LDA.

PORTUGAL

PANADOL TABLET 500MG PHARMATEC PAKISTAN

PANADOL TABLET 500MG WINTHROP PAKISTAN

PANADOL COATED EMBOSSEDTABLETS

500MG SMITHKLINE BEECHAM(IRELAND)

IRELAND

PANADOL 250MG SUPPOSITORIES 250MG GLAXOSMITHKLINESANTE GRAND PUBLIC

FRANCE

PANADOL ACTIFAST TABLETS 500MG SMITHKLINE BEECHAM(IRELAND) LIMITED

IRELAND

PANADOL ACTIFAST TABLET 500MG SMITHKLINE BEECHAM(SWG) LIMITED T/A GSKCONSUMERHEALTHCARE

UNITED KINGDOM

PANADOL BABY AND INFANTSUSPENSION

ORAL SUSPENSION 120MG/5ML SMITHKLINE BEECHAM(SWG) LTD T/A SMITHK.BEEC. CONSUM. HLTHC

UNITED KINGDOM

PANADOL COLD AND FLU CAPLETS NA SMITHKLINE BEECHAMCONSUMERHEALTHCARE

AUSTRALIA

PANADOL EXTRA TABLET N/A PHARMATEC PAKISTAN

PANADOL EXTRA TABLET N/A WINTHROP PAKISTAN

PANADOL EXTRA COATED EMBOSSEDTABLETS

NA SMITHKLINE BEECHAM(IRELAND) LTD

IRELAND

PANADOL EXTRA TABLETS TABLET N/A SMITHKLINE BEECHAM(SWG) LIMITED

UNITED KINGDOM

EL664 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PANADOL SINUS CAPLETS NA SMITHKLINE BEECHAMCONSUMERHEALTHCARE

AUSTRALIA

PANADOL SOLUBLE TABLETS500MG

EFFERVESCENT TABLET 500MG SMITHKLINE BEECHAM(SWG) LTD T/A STERLINGHEALTH

UNITED KINGDOM

PANADOL SUPPOSITORIES SUPPOSITORY 125MG SMITHKLINE BEECHAMSANTE AND HYGIENE

FRANCE

PANADOL TABLETS (500MG) TABLET 500MG SMITHKLINE BEECHAM(SWG) LIMITED T/ASMITHKL. BEEC. CONS.HC

UNITED KINGDOM

PANADOL ULTRA TABLETS N/A SMITHKLINE BEECHAMLTD T/AGLAXOSMITHKLINECONS HEALTHCARE

UNITED KINGDOM

PANAGESIC TABLET 30MG MEDOCHEMIE LTD CYPRUS

PANCURONIUM BROMIDE SOLUTION FORINJECTION

4MG/2ML PHARMAMEDPARENTERALS LTD.

MALTA

PANCURONIUM BROMIDEINJECTION BP 4MG/2ML

SOLUTION FORINJECTION

4MG/2ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

PANETS CAPLETS TABLET 500MG THE BOOTS COMPANYPLC

UNITED KINGDOM

PANETS TABLETS TABLET 500MG THE BOOTS COMPANYPLC

UNITED KINGDOM

PANOXYL ACNEGEL 10 GEL 10% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

PANOXYL ACNEGEL 5 GEL 5% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

PANOXYL AQUAGEL 10 GEL 10% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

PANOXYL AQUAGEL 2.5 GEL 2.5% W/W STIEFEL LABORATORIES(UK) LTD

UNITED KINGDOM

PANOXYL AQUAGEL 5 GEL 5% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

PANOXYL WASH 10% W/W TOPICAL SUSPENSION 10% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

PANTINE TABLET SUGAR-COATED TABLET 15MG CAMDEN INDUSTRIES (M)SDN BHD

MALAYSIA

PANTOGAR CAPSULES N/A ADROKA AG SWITZERLAND

PARA PLUS LOTION IN PRESSURISEDBOT

N/A LABORATORE S.C.A.T FRANCE

PARA SPECIAL POUX (LICE) SHAMPOO N/A LABORATOIRES S.C.A.T FRANCE

PARA SPECIAL POUX (LICE) SOL FOR LOCALAPPLICATION

N/A LABORATOIRES S.C.A.T FRANCE

PARACEN 500 TABLETS 500MG AEGIS LTD. CYPRUS

PARACETAMOL TABLETS 500MG PHARMAMED LTD. MALTA

PARACETAMOL TABLETS 500MG CIPLA LIMITED INDIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 665

Trade Name Dosage Form Dose MA Holder Country

PARACETAMOL 500MG SOLUBLETABLETS

TABLET FOR ORALSOLUTION

500MG SANOFI WINTHROP LTD UNITED KINGDOM

PARACETAMOL BP 500MG TABLET 500MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PARACETAMOL DENK 125 SUPPOSOTORY 125MG E.DENK OHG GERMANY

PARACETAMOL DENK 250 SUPPOSITORY 250MG E.DENK OHG GERMANY

PARACETAMOL DENK 500' SUPPOSITORY 500MG E.DENK OHG GERMANY

PARACETAMOL INFANT DROPS100MG/ML

ORAL SOLUTION 100MG/ML OLINKA UK LIMITED UNITED KINGDOM

PARACETAMOL TABLET B.P.500MG

TABLET 500MG ASPARPHARMACEUTICALS LTD

UNITED KINGDOM

PARACETAMOL TABLET BP500MG

TABLET 500MG ASPARPHARMACEUTICALS LTD

UNITED KINGDOM

PARACETAMOL TABLETS 500MG TABLET 500MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

PARACETAMOL TABLETS 500MG TABLET 500MG SANOFI WINTHROP LTD UNITED KINGDOM

PARACETAMOL TABLETS 500MG TABLET 500MG SANOFI WINTHROPLIMITED

UNITED KINGDOM

PARACETAMOL TABLETS 500MG TABLET 500MG GEOFMANPHARMACEUTICALS

PAKISTAN

PARACETAMOL TABLETS BP500MG

TABLETS 500MG M & A PHARMACHEMLIMITED — UK

UNITED KINGDOM

PARACETAMOL TABLETS BP500MG

TABLET 500MG OBG PHARMACEUTICALSLIMITED

UNITED KINGDOM

PARACETAMOL TABLETS BP500MG

TABLETS 500MG OBG PHARMACEUTICALSLIMITED

UNITED KINGDOM

PARACETAMOL TABLETS BP500MG FEVASTIN

UNCOATED TABLET 500MG TABLET (INDIA) LIMITED INDIA

PARACETAMOL+CAFFEINETABLETS

TABLET N/A SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

PARACETAMOL-RATIOPHARM125 SUPPOSITORIEN

SUPPOSITORY 125MG RATIOPHARM GMBH GERMANY

PARACETAMOL-RATIOPHARM250 SUPPOSITORIEN

SUPPOSITORY 250MG RATIOPHARM GMBH GERMANY

PARACETS TABLET 500MG SUSEEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PARACETS (PARACETS G) CAPSULE 500MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PARACETS PLUS COLD RELIEFCAPS

CAPSULE N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PARACIL TABLET 500 MG TABLET 500MG SM PHARMACEUTICALSSDN BHD

MALAYSIA

PARAFFIN WHITE SOFT BP OINTMENT 100%W/W LCM LTD UNITED KINGDOM

EL666 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PARALDEHYDE INJECTION SOLUTION FORINJECTION

5ML/VIAL F.H. FAULDING & CO LTD(T/A DAVID BULL LABS)

UNITED KINGDOM

PARALIEF TABLETS 500MG CLONMEL HEALTHCARELIMITED

IRELAND

PARAMETTES CHEWABLEMULTIVIT. PLUS IRON

TABLETS N/A WYETH-AYERSTCANADA INC.

CANADA

PARAMOL 500 TABLET TABLET 500MG CAMDEN INDUSTRIES (M)SDN. BHD

MALAYSIA

PARAPLATIN SOLN. FOR I.V INFUSION 450MG/45ML BRISTOL-MYERS SQUIBBS.P.A.

ITALY

PARAPLATIN SOLN. FOR I.V INFUSION 50MG/5ML BRISTOL MYERS SQUIBBS.P.A.

ITALY

PARAPLATIN POWDER FOR INJECTION 450MG BRISTOL-MYERSCOMPANY

UNITED STATES OFAMERICA

PARASUPP 125 MGSUPPOSITORIES

SUPPOSITORIES 125 MG DELTA HF ICELAND

PARASUPP 250 MGSUPPOSITOPRIES

SUPPOSITORIES 125MG DELTA HF ICELAND

PARASUPP 60 MG SUPPOSITORIES SUPPOSITORIES 60 MG DELTA HF ICELAND

PARATABS 160 MGORODISPERSIBLE

TABLET 160MG DELTA HF ICELAND

PARATABS 500 MG TABLETS TABLETS 500MG DELTA HF ICELAND

PARATABS 80 MGORODISPERSIBLE

TABLET 80 MG DELTA HF ICELAND

PARATABS RETARD 500MGPROLONGED-RELEASE

TABLET 500 MG DELTA HF ICELAND

PARCOTEN 500/10 TABLETS N/A AEGIS LTD. CYPRUS

PARIET TABLETS 10MG JANSSEN-CILAG N.V. BELGIUM

PARIET TABLETS 20MG JANSSEN-CILAG N.V. BELGIUM

PARIET 10MG ORAL TABLET 10MG EISAI LTD UNITED KINGDOM

PARIET 20MG ORAL TABLET 20MG EISAI LTD UNITED KINGDOM

PARITREL TABLETS 100MG TRIMA ISRAELPHARMACEUTICALPRODUCTS LIIMITED

ISRAEL

PARKODIN TABLET N/A DELTA HF ICELAND

PARKODIN SUPPOSITORIES N/A DELTA HF ICELAND

PARKODIN FORTE 30/500TABLETS

TABLETS N/A DELTA HF ICELAND

PARKODIN FORTE 30/500MGSUPPOSITORIES

SUPPOSITORIES N/A DELTA HF ICELAND

PARLODEL TABLETS 2.5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

PARLODEL TABLET 2.5MG SANDOZ PAKISTAN

PARLODEL TABLETS 2.5MG NOVARTIS PHARMA N.V BELGIUM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 667

Trade Name Dosage Form Dose MA Holder Country

PARLODEL TABLETS 2.5MG NOVARTIS FARMA SPA ITALY

PARLODEL 2.5MG TABLET 2.5MG NOVARTIS PAKISTAN

PARMOL 120 SYRUP SYRUP 120MG/5ML HOVID SDN. BHD. MALAYSIA

PAROXAT TABLETS 20MG OMEGA FARMA ICELAND

PARPLATIN SOLN. FOR I.V INFUSION 150MG/15ML BRISTOL MYERS SQUIBBS.P.A

ITALY

PARRASUPP 500 MGSUPPOSITORIES

SUPPOSITORIES 500 MG DELTA HF ICELAND

PASSIFLORA TABLETS,NATRACALM

COATED TABLET 71.4MG PETER BLACKHEALTHCARE LTD.

UNITED KINGDOM

PATANOL 0.1% OPHTHALMIC SOLUTION 0.1% W/V ALCON LABORATORIESINC.

UNITED STATES OFAMERICA

PAVULON 4MG=2ML SOLUTION FORINJECTION

2MG/ML N.V. ORGANON (PARTOF AKZO NOBEL)

NETHERLANDS

PAVULON 4MG=2ML SOLUTION FORINJECTION

2MG/ML N.V.ORGANON NETHERLANDS

PAX INJECTION 10MG/2ML SOLUTION FORINJECTION

10MG/2ML PHARMACARE LIMITED SOUTH AFRICA

PAXIDORM TABLETS TABLETS 25MG NORMA CHEMICALSLIMITED

UNITED KINGDOM

PECTYLIN-C EXPECTORANT ORAL LIQUID NA IPCA LABORATORIESLIMITED

INDIA

PEDITRACE CONC. F/SOLUTION F/INF.

N/A PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

PEDITRACE SOLUTION FORINFUSION

N/A FRESENIUS KABI LIMITED UNITED KINGDOM

PEDITRACE SOLUTION FORINFUSION

NA FRESENIUS KABI LIMITED UNITED KINGDOM

PEDVAX HIB VACCINE N/A MERCK SHARP & DOHME NETHERLANDS

PEGASYS SOLUTION FORINJECTION

135MCG/VIAL ROCHE REGISTRATIONLIMITED

EUROPEAN COMMUNITY

PEGASYS SOLUTION FORINJECTION

180MCG/VIAL ROCHE REGISTRATIONLIMITED

EUROPEAN COMMUNITY

PEGINTRON POW.AND SOL.F/SOL.F/INJ.

SEE REMARKS SP EUROPE EUROPEAN COMMUNITY

PELLIT INSECT GEL GEL 1G/100G KARL ENGELHARD GERMANY

PENBRITIN CAPSULE 250MG SMITH KLINE &BEECHAM

PAKISTAN

PENBRITIN CAPSULE 500MG SMITH KLINE &BEECHAM

PAKISTAN

PENBRITIN CAPSULES 250MG CAPSULE 250MG BEECHAM GROUP PLC UNITED KINGDOM

PENBRITIN CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC UNITED KINGDOM

PENBRITIN PAEDIATRIC SUSP.125MG/1.25ML

POWDER FOR ORALSOLUTION

125MG/1.25ML BEECHAM GROUP PLC UNITED KINGDOM

EL668 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PENBRITIN SYRUP 125MG/5ML POWDER FOR ORALSOLUTION

125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM

PENBRITIN SYRUP FORTE POWDER FOR ORALSOLUTION

250MG/5ML BEECHAM GROUP PLC UNITED KINGDOM

PENBRITIN VIALS FOR INJECTION POWDER FOR INJECTION 250MG BEECHAM GROUP PLC UNITED KINGDOM

PENBRITIN VIALS FOR INJECTION POWDER FOR INJECTION 500MG BEECHAM GROUP PLC UNITED KINGDOM

PENFEN TABLETS 50MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

PENFEN SOLUTION FORINJECTION

75MG/3ML ATCO LABORATORIES(PVT) LTD

PAKISTAN

PENICILLAMINE COATED TABLETS 250MG GENERICS (UK) LIMITED UNITED KINGDOM

PENICILLIN VK TABLETS 250MG ATHLONELABORATORIES LIMITED

IRELAND

PENIILLAMINE TABLETS BP250MG

TABLET 250MG GENERICS (UK) LIMITED UNITED KINGDOM

PENODIL CAPSULES 250MG REMEDICA LTD CYPRUS

PENRAZOL E.C. CAPSULE 20MG ELPEN S.A. GREECE

PENSORDIL TABLET 10MG ELPEN S.A GREECE

PENTACOL TABLETS 400MG SOFAR SPA ITALY

PENTACOQ SUSPENSION FORINJECTION

N/A PASTEUR MERIEUX FRANCE

PENTAGLOBIN SOL FOR IV USE 50MG/ML BIOTEST PHARMA GMBH GERMANY

PENTAMIDINE ISETHIONATE SOLUTION FORINJECTION

300MG ABBOTT LABORATORIES UNITED STATES OFAMERICA

PENTASA MESALAZINE ENEMA1G

RECTAL SUSPENSION 1G/100ML FERRINGPHARMACEUTICALSLIMITED

UNITED KINGDOM

PENTASA SUPPOSITORIES IGM SUPPOSITORY 1G FERRINGPHARMACEUTICALSLIMITED

UNITED KINGDOM

PENTASPAN INJECTABLE SOLUTION FORINJECTION

N/A DUPONT PHARMA INC CANADA

PENTAZOCINE CAPSULES 50MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

PENTOSTAM SOLUTION FORINJECTION

10G/100ML THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

PENTOTHAL SODIUM POWDER FOR INJECTION 0.5G ABBOTT S.P.A. ITALY

PENTOTHAL SODIUM POWDER FOR INJECTION 1G ABBOTT S.P.A. ITALY

PEP TABLETS N/A HEALTHY IDEAS LIMITED UNITED KINGDOM

PEPDINE 20MG TABLET 20MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

PEPDINE 40MG TABLET 40MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

PERAZODIN 100 TABLETS 100MG REMEDICA LTD CYPRUS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 669

Trade Name Dosage Form Dose MA Holder Country

PERFANE 100MG/20ML IV INJ. SOLN FORDILUTION

100MG/20ML LABORATOIRES MARIONMERRELL DOW S.A.

FRANCE

PERFORMER MODIFIED RELEASETABLET

750MG VECCHI & PIAM S.A.P.A ITALY

PERFORMER GRANULES FOR ORALSUSP.

250MG/5ML VECCHI & C. PIAMS.A.P.A

ITALY

PERGONAL POWDER FORINJECTABLE SOL

N/A SERONO PHARMA S.P.A. ITALY

PERGONAL 150IU POWDER FOR INJECTION N/A LABORATOIRES SERONOSA

SWITZERLAND

PERGONAL 75IU INJECTABLEPREPARATION

75IU HMG/ML LABORATOIRES SERONOSA

SWITZERLAND

PERIACTIN 4MG TABLET 4MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

PERIDON TABLET 10MG ITALCHIMICI SPA ITALY

PERIDON SUPPOSITORIES 30MG ITALCHIMICI SPA ITALY

PERIDON SUPPOSITORIES 60MG ITALCHIMICI SPA ITALY

PERIDON SYRUP 100MG/100ML ITALCHIMICI SPA ITALY

PERINORM (METOCLOPRAMIDETABLETS BP)

TABLET 10MG IPCA LABORATORIESLIMITED

INDIA

PERISET-4 (ONDANSETRONTABLETS)

TABLET 4MG IPCA LABORATORIESLIMITED

INDIA

PERLUTEX TABLETS 5MG LEO PHARMACEUTICALPRODUCTS

DENMARK

PEROFEN 200 TABLETS 200MG REMEDICA LTD CYPRUS

PERPECTOR DROPS N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

PERSANTIN S.C. TABLET 25MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

PERSANTIN S.C. TABLET 75MG BOEHRIGER INGELHEIMPHARMA KG

GERMANY

PERSANTIN SUGAR COATED TABLET 25MG BOEHRINGER-INGELHEIM PAKISTAN

PERSANTIN TABLETS 100MG BOEHRINGER INGELHEIM PAKISTAN

PERSANTIN 100MG SUGAR COATED TABLET 100MG BOEHRINGER-INGELHEIM PAKISTAN

PERSKINDOL CLASSIC GEL N/A PHARMA-SINGER AG SWITZERLAND

PERSKINDOL CLASSIC SPRAY N/A PHARMA-SINGER AG SWITZERLAND

PERSKINDOL CLASSIC LINIMENT N/A PHARMA-SINGER AG SWITZERLAND

PERSKINDOL CLASSIC BATH-OIL N/A PHARMA-SINGER AG SWITZERLAND

PETHIDINE SOLUTION FORINJECTION

100MG/2ML DUOPHARMA(M)SDN.BHD.

MALAYSIA

PETHIDINE INJECTION BP50MG/ML

SOLUTION FORINJECTION

50MG/ML ANITGENPHARMACEUTICALSLIMITED

IRELAND

EL670 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PETHIDINE INJ. BP SOLUTION FORINJECTION

5% W/V MACARTHYSLABORATORIES LTD T/AMARTINDALEPHARMACEUTICALS

UNITED KINGDOM

PETHIDINE INJECTION SOLUTION FORINJECTION

50MG/1ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

PETHIDINE INJECTION SOLUTION FORINJECTION

100MG/2ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

PEVARYL POWDER 10MG/G JANSSEN-CILAG AG SWITZERLAND

PEVARYL CREAM 10MG/G JANSSEN-CILAG N.V. SWITZERLAND

PEVARYL CREAM 1G/100G JANSSEN-CILAG N.V. BELGIUM

PEVARYL MILK 10MG/G JANSSEN-CILAG AG SWITZERLAND

PEVARYL 1% SOLUTION 1G/100G JANNSEN-CILAG AG SWITZERLAND

PEVARYL LIPOGEL GEL 10MG/G JANSSEN-CILAG AG SWITZERLAND

PEVARYL PV FOAMING SOLUTION 1G/100G JANSSEN-CILAG AG SWITZERLAND

PEVARYL SHAMPOO SOLUTION 10MG/G JANSSEN-CILAG AG SWITZERLAND

PEVISONE CREAM N/A JANSSEN-CILAG AG SWITZERLAND

PEVISONE CREAM N/A JANSSEN-CILAG N.V. BELGIUM

PHARMATOVIT CAPSULES N/A PHARMATON SA SWITZERLAND

PHENERGAN ELIXIR 5MG/5ML RHONE-POULENC-RORER PAKISTAN

PHENERGAN ELIXIR ORAL SOLUTION 5MG/5ML MAY & BAKER LIMITED UNITED KINGDOM

PHENERGAN INJECTION 2.5% W/V SOLUTION FORINJECTION

2.5% W/V MAY & BAKER LIMITED(REFER TO CPP)

UNITED KINGDOM

PHENERGAN TABLETS 10MG COATED TABLET 10MG MAY & BAKER LIMITED(T/A RHONE-POULENCRORER)

UNITED KINGDOM

PHENERGAN TABLETS 25MG COATED TABLET 25MG MAY & BAKER LIMITED(T/A RHONE-POULENCRORER)

UNITED KINGDOM

PHENINDIONE TABLETS TABLETS 50MG GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

PHENOBARBITAL TABLETS 30MG PHARMAMED LTD. MALTA

PHENOBARBITONE BP 60MG TABLET 60MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PHENOBARBITONE BP 15MG TABLETS 15MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PHENOBARBITONE BP 30MG TABLET 30MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PHENOBARBITONE TABLETS BP30MG

TABLETS 30MG APPROVEDPRESCRIPTION SERVICESLIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 671

Trade Name Dosage Form Dose MA Holder Country

PHENOL OILY BP OIL FOR INJECTION 5%W/V EVANS MEDICAL LIMITED UNITED KINGDOM

PHENOXYBENZAMINE INJECTIONCONCENTRATE

SOLUTION FORINJECTION

100MG/2ML FORLEY LIMITED IRELAND

PHENOXYMETHYLPENICILLIN 250 TABLETS 250 MG REMEDICA LTD CYPRUS

PHENSEDYL WITH CODEINECOUGH LINCTUS

ORAL SOLUTION N/A MAY & BAKER (T/ARHONE-POULENCRORER)'

UNITED KINGDOM

PHENYLBUTAZONE BP 100MG TABLET 100MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PHENYLBUTAZONE BP 200MG TABLET 200MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PHILLIP'S MILK OF MAGNESIA ORAL SUSPENSION 415MG/5ML SMITHKLINE BEECHAM(SWG) LTD T/A STERLINGHEALTH

UNITED KINGDOM

PHILLIP'S MILK OF MAGNESIATABLETS

TABLET 300MG SMITHKLINE BEECHAM(SWG) LTD T/A STERLINGHEALTH/SKB INTRNTL

UNITED KINGDOM

PHLOGENZYM GASTRO-RESISTANTTABLET

N/A MUCOS PHARMA GMBH& CO.

GERMANY

PHOLCODINE LINCTUS B.P. ORAL SOLUTION 5MG/5ML WILLIAM RANSOM &SON PLC

UNITED KINGDOM

PHOLCODINE LINCTUS BP ORAL SOLUTION 5MG LCM LTD UNITED KINGDOM

PHOSPHATE SODIQUE DEDEXAMETHASONE MERCK

SOL FOR INJECTION INAMP

4MG MERCK GENERIQUES FRANCE

PHYLLOCONTIN CONTINUSTABLETS 225MG

MODIFIED RELEASETABLET

225MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

PHYLLOCONTIN FORTECONTINUS TABS. 350MG

MODIFIED RELEASETABLETS

350MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

PHYLLOCONTIN PAEDIATRICCONTINUS TABLETS

MODIFIED RELEASETABLET

100MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

PHYSIONEAL GLUCOSE SOL.F PERITONEALDIALYSIS

N/A BAXTER HEALTHCARELIMITED UK

IRELAND

PHYSIONEAL GLUCOSE SOLUTION N/A BAXTER HEALTHCARELIMITED UK

IRELAND

PHYSIONEAL GLUCOSE 3.86%W/V SOL. F. PERITONEALDIALYS

N/A BAXTER HEALTHCARELIMITED UK

IRELAND

PHYSIOTENS 0.2 FILM COATED TABLET 0.2MG SOLVAY ARZNEIMITTELGMBH

GERMANY

PHYSIOTENS 0.3 FILM COATED TABLET 0.3MG SOLVAY ARZNEIMITTELGMBH

GERMANY

PHYSIOTENS 0.4 FILM COATED TABLET 0.4MG SOLVAY ARZNEIMITTELGMBH

GERMANY

PHYTEX PAINT PAINT N/A WYNLIT LABORATORIESLIMITED

UNITED KINGDOM

PHYTOMENADIONE INJECTION BP10MG (VITAMIN K1 INJECTION10MG)

SOLUTION FORINJECTION

10MG/1ML ROTEXMEDICA GMBH,ARZNEIMITTELWERK

GERMANY

EL672 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PICKLES OINTMENT OINTMENT N/A J PICKLES (HARROGATE)LIMITED T/A J. PICKLESAND SON

UNITED KINGDOM

PICOLAX POWDER POWDER FOR ORALSOLUTION

N/A FERRINGPHARMACEUTICALSLIMITED

UNITED KINGDOM

PICO-SALAX POWDER SINGLE DOSE N/A FERRING AB SWEDEN

PIL-FOOD CAPSULE N/A LABORATOIRE GOLAZSA

SWITZERLAND

PIL-FOOD CAPSULES CAPSULES NA LABORATOIRE GOLAZSA

SWITZERLAND

PILOCARPINA CLORIDRATO SOLUTION 4% COLLIRIO TUBILUX PHARMA S.P.A. ITALY

PILOCARPINE 1% EYE DROPS (OPTIFILM) 0.01G/ML AMOUNPHARMACEUTICALINDUSTRIES CO.

EGYPT

PILOCARPINE 2% EYE DROPS(OPTIFILM) 0.02G/ML AMOUNPHARMACEUTICALINDUSTRIES CO.

EGYPT

PILOCARPINE EYE DROPS 0.5% EYE DROPS 0.5% W/W SCHERING-PLOUGHLIMITED

UNITED KINGDOM

PILOCARPINE EYE DROPS 1% BP EYE DROPS 1% W/V SCHERING-PLOUGHLIMITED

UNITED KINGDOM

PILOCARPINE EYE DROPS 2% BP EYE DROPS 2% W/V SCHERING-PLOUGHLIMITED

UNITED KINGDOM

PILOCARPINE EYE DROPS 3% EYE DROPS 3% W/V SCHERING-PLOUGHLIMITED

UNITED KINGDOM

PILOCARPINE EYE DROPS 4% EYE DROPS 4% W/V SCHERING-PLOUGHLIMITED

UNITED KINGDOM

PILOCARPINE EYE DROPS BP 1% EYE DROPS 1%W/V MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

PILOCOLLYRE EYE DROPS SOLUTION 4% W/V COOPER S.A. GREECE

PILOCOLLYRE EYE DROPS SOLUTION 1% W/V COOPER S.A. GREECE

PILOCOLLYRE EYE DROPS SOLUTION 2% W/V COOPER S.A. GREECE

PILODREN EYE DROPS N/A FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

PILOPOS 2% EYE DROPS 2% W/V URSAPHARMARZNEIMITTEL GMBH

GERMANY

PILOTONINA EYE DROPS 2% W/V FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

PILOTONINA EYE DROPS 4% W/V FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

PIMAFUCIN CREAM 20MG/G YAMANOUCHI PHARMAB.V.

NETHERLANDS

PIMAFUCORT CREAM N/A YAMANOUCHI PHARMAB.V.

NETHERLANDS

PINADONE METHADONEMIXTURE DTF

ORAL SOLUTION 1MG/ML PINEWOODLABORATORIES LIMITED

IRELAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 673

Trade Name Dosage Form Dose MA Holder Country

PINADONE METHADONEMIXTURE DTF

ORAL SOLUTION, SUGARFREE

1MG/ML PINEWOODLABORATORIES LIMITED

IRELAND

PINORAX STRONGCO-DANTHRAMER

ORAL SUSPENSION 75/1000 PINEWOODLABORATORIES LIMITED

IRELAND

PIPRIL 1G POWDER FOR INJECTION 1G/10ML LEDERLEPHARMACEUTICALS

GERMANY

PIPRIL 2G POWDER FOR INJECTION 2G/20ML LEDERLE ARZNEIMITTELGMBH & CO

GERMANY

PIPRIL INJECTION POWDER FOR INJECTION 4G/VIAL CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

PIPRIL INJECTION POWDER FOR INJECTION 2G/VIAL CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

PIRACTAM CAPSULES 10MG KOREA UNITED PHARM.INC.

KOREA REPUBLIC

PIRFALIN OPHTHALMIC DROPS 0.005% W/V FARMIGEA SPA ITALY

PIRITON TABLET 4MG STAFFORD-MILLERLIMITED

UNITED KINGDOM

PIRITON SYRUP 2MG/5ML STAFFORD-MILLERLIMITED

UNITED KINGDOM

PIRITON SYRUP SYRUP (ORAL SOLUTION) 2MG/5ML STAFFORD MILLERLIMITED

UNITED KINGDOM

PIRITON TABLETS TABLET 4MG STAFFORD MILLERLIMITED

UNITED KINGDOM

PIROXICAM CAPSULES 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

PIROXICAM CAPSULE 20MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

PITRESSIN SOLUTION FORINJECTION

0.4 MG/1 ML GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

PITRESSIN AMPOULES SOLUTION FORINJECTION

20PU GOLDSHIELDPHARMACEUTICALSLIMITED

UNITED KINGDOM

PK-MERZ INFUSION SOLUTION 200 MG MERZ+CO. GMBH & CO. GERMANY

PK-MERZ TABLETS 100 MG MERZ+CO. GMBH & CO. GERMANY

PLACIS INJECTABLE SOLUTION 10MG/10ML CHIESI ESPANA S.A. SPAIN

PLACIS INJECTABLE SOLUTION 50MG/50ML CHIESI ESPANA S.A. SPAIN

PLACIS 10MG SOLUTION INJECTABLE 10MG/20ML CHIESI WASSERMANNS.A.

SPAIN

PLACIS 50MG SOLUTION INJECTABLE 50MG/50ML CHIESI WASSERMANNS.A.

SPAIN

PLAQUENIL TABLET 200MG SANOFI WINTHROP LTD. UNITED KINGDOM

PLASMA-LYTE 148 ELECTROLYTESOL IN WATER

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

PLATINWAS INJECTABLE SOLUTION 150MG/15ML CHIESI ESPANA S.A. SPAIN

EL674 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PLAVIX FILM COATED TABLETS 75MG SANOFI PHARMABRISTOL-MYERS SQUIBBSNC

FRANCE

PLEGISOL SOLUTION N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

PLEGISOL SOLN F/CARDIACPERFUSION

SOLN F/CARDIACPERFUSION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

PLEGIVEX CARDIOPLEGIA SOLUTION NA GALEN LIMITED UNITED KINGDOM

PLENDIL PROLONGED RELEASETABLETS

5MG HASSLE LAKEMEDEL AB SWEDEN

PLENDIL PROLONGED RELEASETABLETS

10MG HASSLE LAKEMEDEL AB SWEDEN

PMS- HALOPERIDOL SOLUTION ORAL SOLUTION 2MG/ML PHARMASCIENCE INC. CANADA

PMS-IPRATROPIUM LIQUID 250MCG/ML PHARMASCIENCE INC. CANADA

PMS-SELEGILENE TABLET 5MG PHARMASCIENCE INC. CANADA

PNEUMO 23 SOLUTION FORINJECTION

N/A PASTEUR MERIEUX FRANCE

PNEUMOREL 0.2% SYRUP 0.2% W/V LES LABORATOIRESSERVIER

FRANCE

PNEUMOREL 80MG COATED TABLET 80MG LES LABORATOIRESSERVIER

FRANCE

POFOL INJECTION SUSPENSION FORINJECTION

10MG/ML DONG KOOK PHARM.CO. LTD

KOREA REPUBLIC

POLARAMINE SYRUP 0.40MG/ML SCHERING-PLOUGHNV/SA

BELGIUM

POLARAMINE EXPECTORANT SYRUP N/A SCHERING-PLOUGH S.A. BELGIUM

POLARMINE REPETABS 6MG SCHERING-PLOUGHNV/SA

BELGIUM

POLARONIL TABLETS N/A SCHERING-PLOUGH S.A. BELGIUM

POLJODURATO OPHTHALMIC DROPS N/A FARMIGEA SPA ITALY

POLYDERM OINTMENT USP OINTMENT N/A TAROPHARMACEUTICALS INC.

CANADA

POLYFAX OPHTHALMIC OINTMENT N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

POLYFAX OINTMENT OINTMENT N/A THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

POLYGNAX VAGINAL CAPSULE N/A LABORATOIREINNOTECHINTERNATIONAL

FRANCE

POLYGYNAX VAGINAL CAPSULE N/A LABORATOIREINNOTECHINTERNATIONAL

FRANCE

POLYOSIDE MENINGOCOCCALA+C VACCINE

INJECTABLE N/A PASTEUR MERIEUX FRANCE

POLYSILANE DELALANDE CHEWABLE TABLET N/A LABORATOIRESSYNTHELABO

FRANCE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 675

Trade Name Dosage Form Dose MA Holder Country

POLYSILANE NOURRISSONJOULLIE

GRANULATES N/A LABORATOIRESSYNTHELABO

FRANCE

POLYTAR LIQUID 1% W/W STIEFEL LABORATORIES(UK) LTD

IRELAND

POLYTAR ANTI-FUNGAL SHAMPOO N/A STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

POLYTAR EMOLLIENT TOPICAL SOLUTION 25% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

POLYTAR PLUS TOPICAL SOLUTION 1% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

POLYTONYL FOR ADULTS POWDER FOR ORALSOLN

N/A UPSA CONSEIL FRANCE

POLYTONYL FOR CHILDREN POWDER FOR ORALSOLN

N/A UPSA CONSEIL FRANCE

POLYTRIM OPHTHALMIC OINTMENT N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

POLYTRIM EYE DROPS N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

PONDOCILLIN TABLETS 500MG LEO PHARMACEUTICALPRODUCTS

DENMARK

PONSTAN SYRUP 50MG/5ML PARKE DAVIS &COMPANY

UNITED KINGDOM

PONSTAN CAPSULE 250MG PARKE-DAVIS GMBH GERMANY

PONSTAN FORTE FILMCOATED TABLET 500MG GODECKE AG GERMANY

PONSTAN FORTE TABLET 500MG PARKE DAVIS PAKISTAN

PONSTAN FORTE TABLET 500MG PARKE-DAVIS PAKISTAN

PONSTYL CAPSULE 250MG PARKE-DAVIS AFRIQUEDE L'OUEST

SENEGAL

PONSTYL FORT 500MG TABLET 500MG PARKE-DAVIS AFRIQUEDE L'OUEST

SENEGAL

PONSTYL SIROP ENFANT SYRUP 50MG/5ML PARKE-DAVIS AFRIQUEDE L'OUEST

SENEGAL

PORFYROCIN 125MG/5ML POWDER FOR OR.SUSPENSION

125MG/5ML MEDOCHEMIE LTD CYPRUS

PORFYROCIN 250MG/5ML POWDER FOR OR.SUSPENSION

250MG/5ML MEDOCHEMIE LTD CYPRUS

PORFYROCIN 500MG/5ML POWDER FOR OR.SUSPENSION

500MG/5ML MEDOCHEMIE LTD CYPRUS

PORPHYROCIN 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

POSALFILIN OINTMENT N/A NORGINE LIMITED UNITED KINGDOM

POSALFILIN OINTMENT N/A NORGINE LIMITED UNITED KINGDOM

POSIFENICOL 1 % EYE DROPS 1 % W/V URSAPHARMARZNEIMITTEL GMBH

GERMANY

POSIFENICOL C 1 % EYE OINTMENT 1 % W/W URSAPHARMARZNEIMITTEL GMBH

GERMANY

EL676 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

POTABA ENVULES 3G ORAL POWDER 3G GLENWOOD UNITED KINGDOM

POTASSIUM CHLORIDE 20%AGUETTANT

SOLUTION FORINFUSION

20G/100ML LABORATOIREAGUETTANT

FRANCE

POTASSIUM CHLORIDE 20%AGUETTANT

INJECTABLE SOLUTION 20% W/V LABORATOIREAGUETTANT

FRANCE

POTRELEASE TR TABLET 600MG TABLET 600MG SM PHARMACEUTICALSSDN BHD

MALAYSIA

POVIDONE IODINE TOPICAL SOLUTION 10GM/100ML AMOUNPHARMACEUTICAL COS.A.E

EGYPT

PR HEAT SPRAY TOPICAL SPRAY N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

PRAZIQUANTEL FILM COATED TABLETS 600MG PHARMAMED LTD. MALTA

PRAZOSIN TABLETS BP 0.5MG TABLETS 0.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

PRAZOSIN TABLETS BP 1MG TABLETS 1MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

PRAZOSIN TABLETS BP 2MG TABLETS 2MG NORTON HEALTHCARELIMTED

UNITED KINGDOM

PRAZOSIN TABLETS BP 5MG TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

PRECONCEIVE TABLETS 400MCG TABLET 400MCG G R LANE PRODUCTSLTD

UNITED KINGDOM

PRED FORTE OPHTHALMICSUSPENSION

1% W/V ALLERGANPHARMACEUTICALS(IRELAND) LTD., INC.

IRELAND

PREDFOAM FOAM RETENTIONENEMA

31.4MG/DOSE PHARMAX LIMITED UNITED KINGDOM

PREDNISOLON TABLETS 5MG NYCOMED AUSTRIAGMBH

AUSTRIA

PREDNISOLONE ENTERIC COATEDTABLETS

5MG BIOREX LABORATORIESLTD.

UNITED KINGDOM

PREDNISOLONE TABLET 5MG CAMDEN INDUSTRIES (M)SDN.BHD

MALAYSIA

PREDNISOLONE TABLETS 20MG CLONMEL HEALTHCARELIMITED

IRELAND

PREDNISOLONE BP 1MG TABLET 1MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PREDNISOLONE BP 5MG TABLETS 5MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PREDNISOLONE TABLETS BP 1MG TABLETS 1MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

PREDNISOLONE TABLETS BP 1MG TABLET 1MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

PREDNISOLONE TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

PREDNISOLON-RATIOPHARM 5 TABLET 5MG RATIOPHARM GMBH GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 677

Trade Name Dosage Form Dose MA Holder Country

PREFRIN PHENYLEPHRINE HCLLIQUIFILM

EYE DROPS 1.2MG/ML ALLERGANPHARMACEUTICALS(IRELAND) LTD., INC.

IRELAND

PREMAK-C TABLET N/A JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES— UK

UNITED KINGDOM

PREMAK-C COATED TABLET 1.25MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES— UK

UNITED KINGDOM

PREMARIN TABLET 0.625MG WYETH LEDERLE PAKISTAN

PREMARIN 0.625MG TABLET 0.625MG WYETH-LEDERLE PAKISTAN

PREMARIN 0.625MG TABLETS 0.625MG JOHN WYETH &BROTHER LTD.

UNITED KINGDOM

PREMARIN 0.625MG COATED TABLET 0.625MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES -UK

UNITED KINGDOM

PREMARIN 1.25MG TABLET 1.25MG WYETH-LEDERLE PAKISTAN

PREMARIN 1.25MG TABLETS 1.25MG JOHN WYETH &BROTHER LTD.

UNITED KINGDOM

PREMARIN COATED TABLET COATED TABLET 0.625MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES

UNITED KINGDOM

PREMARIN TABLETS 1.25MG. TABLET 1.25MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES— UK

UNITED KINGDOM

PREMARIN VAGINAL CREAM CREAM 0.625MG / G WYETH-AYERSTCANADA INC.

CANADA

PREMARIN VAGINAL CREAM CREAM 34.72MG JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES -UK

UNITED KINGDOM

PREMELLE 2.5 TABLETS NA JOHN WYETH ANDBROTHER LIMITED

IRELAND

PREMELLE 5 TABLET N/A JOHN WYETH &BROTHER LTD

UNITED KINGDOM

PREMELLE CYCLE 10 TABLETS TABLETS NA JOHN WYETH &BROTHER LIMITED T/AWYETH LABORATORIES

UNITED KINGDOM

PREMELLE CYCLE 5 TABLETS NA JOHN WYETH ANDBROTHER LIMITED

IRELAND

PREMIQUE COATED TABLETS NA JOHN WYETH &BROTHER LIMITED

UNITED KINGDOM

PREMIQUE CYCLE TABLETS NA JOHN WYETH &BROTHER

UNITED KINGDOM

PREMPACK-C 0.625MG TABLETS 0.625MG JOHN WYETH &BROTHER LTD

UNITED KINGDOM

PREMPACK-C 0.625MG TABLETS 0.625MG JOHN WYETH &BROTHER LTD

UNITED KINGDOM

EL678 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PREMPACK-C 1.25MG TABLET 1.25MG JOHN WYETH &BROTHER LTD.

UNITED KINGDOM

PREMPAK-C 1.25MG TABLETS 1.25MG JOHN WYETH &BROTHER LTD

UNITED KINGDOM

PRENOL TABLETS 5MG AEGIS LTD CYPRUS

PREPERATION H OINTMENT N/A WHITEHALLLABORATORIES LTD

UNITED KINGDOM

PREPERATION H SUPPOSITORIES N/A WHITEHALLLABORATORIES LTD

UNITED KINGDOM

PREPULSID (CYPRID) 5MG TABLET 5MG JANSSEN-CILAG N.V. BELGIUM

PREPULSID 10MG TABLET 10MG JANSSEN-CILAG N.V. BELGIUM

PREPULSID 1MG/ML ORAL SUSPENSION 1MG/ML JANSSEN-CILAG N.V. BELGIUM

PRESSICAINE A SANSVASOCONSTRICTEUR 3%

SOLN FOR DENTALINJECTION

3% W/V LABORATOIRES SPAD FRANCE

PRESSICAINE N SOLUTION FOR DENTALINJ

N/A LABORATOIRES SPAD FRANCE

PRETERAX SCORED TABLET N/A LES LABORATOIRESSERVIER

FRANCE

PREVENAR SUSPENSION FORINJECTION

NA WYETH LEDERLEVACCINES SA

EUROPEAN COMMUNITY

PRIMALAN SYRUP 0.03G/60ML LABORATOIRES PIERREFABRE MEDICAMENT

FRANCE

PRIMALAN 5MG SCORED TABLET 5MG LABORATOIRES PIERREFABRE MEDICAMENT

FRANCE

PRIMOLUT N TABLET 5MG SCHERING AG GERMANY

PRIMOLUT N TABLET 5MG SCHERING PAKISTAN

PRIMOLUT N TABLETS 5MG SCHERING PAKISTAN

PRIMOLUT N TABLET 5MG SCHERING HEALTH CARELIMITED

UNITED KINGDOM

PRIMPERAN ORAL SOLUTION DROPS 260MG/100ML LABORATOIRESSYNTHELABO

FRANCE

PRIMPERAN 0.1% ORAL SOLUTION 0.1% W/V LABORATOIRESSYNTHELABO

FRANCE

PRIMPERAN 10MG SCORED TABLET 10MG LABORATOIRESSYNTHELABO

FRANCE

PRIMPERAN 10MG/2ML SOLUTION FORINJECTION

10MG/2ML LABORATOIRESSYNTHELABO

FRANCE

PRIODERM LOTION 0.5% LOTION 0.5%W/V MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

PRIODERM SHAMPOO SHAMPOO 1%W/W MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

PRIORIX POWDER FOR INJECTION N/A SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

PRITOR TABLETS 80MG GLAXO GROUP LTD. UNITED KINGDOM

PRITOR TABLETS 40MG GLAXO GROUP LTD. UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 679

Trade Name Dosage Form Dose MA Holder Country

PROCARDIN 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

PROCARDIN 75MG TABLET 75MG MEDOCHEMIE LTD CYPRUS

PROCHLORPERAZINE TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

PROCHLORPERAZINE INJECTION SOLUTION FORINJECTION

1.25%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

PROCHLORPERAZINE INJECTIONBP

SOLUTION FORINJECTION

12.5MG/ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

PROCHLORPERAZINE MALEATE TABLETS 5MG PHARMAMED LTD. MALTA

PROCTOFOAM HEMORRHOIDAL FOAM N/A SCHWARZ PHARMA UNITED STATES OFAMERICA

PROCTOFOAM-HC TOPICAL AEROSOL N/A SCHWARZ PHARMA INC. UNITED STATES OFAMERICA

PROCTO-GLYVENOL CREAM N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

PROCTO-GLYVENOL SUPPOSITORIES N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

PROCTOSEDYL OINTMENT OINTMENT N/A HOECHST MARIONROUSSEL LIMITED

UNITED KINGDOM

PROCTOSEDYL SUPPOSITORIES SUPPOSITORY N/A HOECHST MARIONROUSSEL LIMITED

UNITED KINGDOM

PROCTOSOLL CREAM N/A ALFA WASSERMANNS.P.A.

ITALY

PROCYCLIDINE TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

PROCYCLIDINE SYR. SUG. FREEARPICOLIN SF

ORAL SOLUTION 5MG/5ML ROSEMONTPHARMACEUTICALSLIMITED

UNITED KINGDOM

PROFASI 10000 IU INJECTABLEPREPARATION

10000 IU HCG/ML LABORATOIRES SERONOSA

SWITZERLAND

PROFASI 5000IU INJECTABLEPREPARATION

5000IU HCG/ML LABORATOIRES SERONOSA

ITALY

PROFASI HP POWDER AND SOLVENTFOR INJ.

N/A SERONO PHARMA S.P.A. ITALY

PROFENID GEL 2.5% LABORATOIRES AVENTIS FRANCE

PROFENID 100MG SUPPOSITORIES 100MG LABORATOIRES SPECIA FRANCE

PROFENID 100MG FILM-COATED TABLET 100MG LABORATOIRES SPECIA FRANCE

PROFENID 100MG (IV USE) POWDER F.SOLN.F.INJECTION

100MG/VIAL RHONE-POULENC RORER FRANCE

PROFENID 100MG,INTRAMUSCULAR

POWDER AND SOLVENTFOR INJ

N/A SPECIA LABORATORIES FRANCE

PROFENID 2.5 PER CENT GEL N/A RPR SPECIALABORATORIES

FRANCE

PROFENID 50MG CAPSULE 50MG LABORATOIRES SPECIA FRANCE

PROFENID LP 200MG SR FILM COATED TABLET 200MG RHONE-POULENC RORER FRANCE

EL680 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PROFLAVINE CREAM B.P.C.1973 CREAM N/A THORNTON & ROSS LTD UNITED KINGDOM

PROGEMOX TABLET 1G PROGE FARM S.R.L. ITALY

PROGEMOX COMPRESSE 1G PROGE FARM S.R.L ITALY

PROGERON TABLETS 100MG REMEDICA LTD. CYPRUS

PROGESTOGEL 1 POUR CENT GEL N/A BESINS INTERNATIONAL FRANCE

PROGRAF CAPSULES 1MG HIKMAPHARMACEUTICALS

JORDAN

PROGRAF CAPSULES 5MG HIKMAPHARMACEUTICALS

JORDAN

PROGYLUTON COATED TABLET N/A SCHERING AG GERMANY

PROGYNOVA 2MG TABLET COATED TABLET 2MG SCHERING HEALTH CARELTD

UNITED KINGDOM

PROGYNOVA TS TRANSDERMAL PATCH 3.8MG SCHERING HEALTH CARELTD

UNITED KINGDOM

PROGYNOVA TS FORTE TRANSDERMAL PATCH 7.6MG SCHERING HEALTH CARELTD

UNITED KINGDOM

PROHANCE SOLN FOR I.V INJECTION 2.79.3MG/ML BRACCO S.P.A ITALY

PROHANCE SOLN FOR IV INJECTION 279.3MG/ML BRACCO S.P.A ITALY

PROMENSIL TABLET 200MG NOVOGENLABORATORIES PTY LTD

AUSTRALIA

PROMETHAZINE TABLETS 25MG REMEDICA LTD. CYPRUS

PROMETHAZINE HCL SYRUPPLAIN

SYRUP 6.25MG/5ML WYETH-AYERSTLABORATORIES

UNITED STATES OFAMERICA

PROMETHAZINE HCL12.5MG TABLETS 12.5MG WYETH-AYERSTLABORATORIES

UNITED STATES OFAMERICA

PROMETHAZINEHYDROCHLORIDE

TABLETS 25MG PHARMAMED LTD. MALTA

PRONESTYL TABLETS 250MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

PRONTOPYRIN PLUS TABLETS N/A HEINRICH MACK NACHF GERMANY

PROPA PH FOAMING FACE WASH FACE WASH N/A DEL LABORATORIES INC. UNITED STATES OFAMERICA

PROPAFENON «GENERICON» FILM COATED TABLETS 150MG GENERICON PHARMAGES.M.B.H

AUSTRIA

PROPANTHELINE TABLETS 15MG REMEDICA LTD. CYPRUS

PROPECIA 1MG TABLETS FILM COATED TABLET 1MG MERCK SHARP & DOHMELIMITED

UNITED KINGDOM

PROPECIA TABLETS TABLET 1MG MERCK & CO. INC UNITED STATES OFAMERICA

PROPESS PESSARY 10MG CONTROLLEDTHERAPEUTICS(SCOTLAND) LIMITED

UNITED KINGDOM

PROPESS 10MG VAGINAL PESSARY 10MG CONTROLLEDTHERAPEUTICS(SCOTLAND) LIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 681

Trade Name Dosage Form Dose MA Holder Country

PROPESS 10MG PESSARY 10MG CONTROLLEDTHERAPEUTICS(SCOTLAND) LTD.

UNITED KINGDOM

PROPESS 10MG PESSARY 10MG CONTROLLEDTHERAPEUTICS(SCOTLAND) LIMITED

UNITED KINGDOM

PROPOFOL EMULSION FOR IV INJ /INF

10MG/ML ABBOTT LABORATORIES UNITED KINGDOM

PROPOFOL ABBOTT EMULSION FOR IV INJ./INF.

10MG/ML ABBOTT AG SWITZERLAND

PROPOFOL-LIPURO 1% (10MG/ML) EMULSION FOR INJ. ORINFU

10MG/ML B.BRAUN MELSUNGENAG

GERMANY

PROPRANOLO BP 80MG TABLET 80MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PROPRANOLOL TABLETS 40MG PHARMAMED LTD. MALTA

PROPRANOLOL BP 10MG TABLET 10MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PROPRANOLOL BP 40MG TABLET 40MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

PROPRANOLOL TABLET 40MG TABLET 40MG RAZA MANUFACTURINGBERHAD

MALAYSIA

PROPYLTHIOURACIL BP TABLET 50MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

PROPYLTHIOURACIL TABLETS BP50MG

TABLETS 50MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

PROPYLTHIOURACIL TABLETS BP50MG

TABLET 50 MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

PROSCAR 5MG TABLET 5MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

PROSPAN COUGH SYRUP SYRUP 0.7G/100ML KARL ENGELHARD GERMANY

PROSPAN HERBAL DROPS DROPS 20MG/ML KARL ENGELHARD GERMANY

PROSTAP SR LEUPROPELINACETATE DEPOT INJ

POWDER FOR INJECTION 3.75MG/VIAL CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

PROSTATONIN CAPSULE N/A PHARMATON SA SWITZERLAND

PROSTIN 15M INJECTABLE SOLUTION 0.25MG/ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

PROSTIN E2 CONC. FOR SOL. FOR INJ. 10MG/ML PHARMACIA & UPJOHNN.V./ S.A.

BELGIUM

PROSTIN E2 CONC. FOR SOL. FORINF.

1MG/ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

PROSTIN E2 VAGINAL GEL 1MG/3G PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

PROSTIN E2 VAGINAL GEL 2MG/3G PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

PROSTIN E2 VAGINAL TABLETS 3MG PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

EL682 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PROSTIN VR 0.5MG CONC. FOR SOL. FORINF.

0.5MG/ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

PROSULF SOLUTION FORINJECTION

10MG/ML CP PHARMACEUTICALSLTD.

UNITED KINGDOM

PROSULF INJECTION1%,PROTAMINE SULPHATE

SOLUTION FORINJECTION

10MG/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

PROTAMINE SULPHATEINJECTION BP

SOLUTION FORINJECTION

50MG/5ML EVANS MEDICAL LIMITED UNITED KINGDOM

PROTAMINE SULPHATEINJECTION BP,50MG/5ML

SOLUTION FORINJECTION

10MG/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

PROTAMINE SULPHATE LEO SOLUTION FORINJECTION

10MG/ML LEO PHARMACEUTICALPRODUCTS

DENMARK

PROTHIAZINE TABLETS 25MG CTS CHEMICALINDUSTRIES

ISRAEL

PROTHIAZINE SYRUP 5MG/5ML CTS CHEMICALINDUSTRIES

ISRAEL

PROTHIAZINE SYRUP SYRUP 5MG/5ML CTS CHEMICALINDUSTRIES LTD

ISRAEL

PROTOMID TABLET 250MG MACLEODS INDIA

PROTOP CAPSULE 20MG PT INTERBAT INDONESIA

PROTOP CAPSULES BOX,BOTTLE 14

20 MG/CAP PT INTERBAT INDONESIA

PROVERA TABLETS 5MG PHARMACIA N.V. / S.A. BELGIUM

PROVERA TABLETS 100MG PHARMACIA & UPJOHNS.P.A.

ITALY

PROVERA TABLETS 100MG PHARMACIA ITALIA SPA ITALY

PROVIRON TABLET 25MG SCHERING AG GERMANY

PROVIRON TABLET 25MG SCHERING PAKISTAN

PROVIRON TABLETS TABLET 25MG SCHERING PAKISTAN

PRO-VIRON TABLETS TABLETS 25MG SCHERING HEALTH CARELIMITED

UNITED KINGDOM

PROVISC OCULAR VISCOELASTICSOLN.

10MG/ML S.A. ALCON-COUVREURN.V.

BELGIUM

PROXEN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

PROXIL 250MG TABLET 250MG CODAL SYNTO LTD CYPRUS

PROZAC CAPSULE 20MG ELI LILLY & COMPANYLIMITED

UNITED KINGDOM

PROZAC WKLY DELAYED RELEASECAPS

90MG ELI LILLY AND COMPANY UNITED STATES OFAMERICA

PRURI-MED SKIN CLEANSINGEMULSION

N/A PERMAMED AG SWITZERLAND

PSILO-BALSAM N GEL N/A STADA OTCARZNEIMITTEL GMBH

GERMANY

PTU TABLETS 50MG MACLEODSPHARMACEUTICALS LTD

INDIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 683

Trade Name Dosage Form Dose MA Holder Country

PULANIL TABLETS 200MG HANBUL PHARMA KOREA

PULMEX OINTMENT N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

PULMEX BABY OINTMENT N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

PULMICORT INHALATIONSUSPENSION

0.25MG/ML DRACO LAKEMEDEL AB SWEDEN

PULMICORT INHALATIONSUSPENSION

0.5MG/ML DRACO LAKEMEDEL AB SWEDEN

PULMICORT AEROSOL FORINHALATION

50MCG/DOSE DRACO LAKEMEDEL AB SWEDEN

PULMICORT AEROSOL FORINHALATION

200MCG/DOSE DRACO LAKEMEDEL AB SWEDEN

PULMICORT INHALER 50MCG BARRETT HODGSON PAKISTAN

PULMICORT TURBUHALER INHALATION POWDER 100MCG/DOSE DRACO LAKEMEDEL AB SWEDEN

PULMICORT TURBUHALER INHALATION POWDER 200MCG/DOSE DRACO LAKEMEDEL AB SWEDEN

PULMO BAILLY ORAL LIQUID NA DDD LIMITED UNITED KINGDOM

PULMOCIS POWDER FOR INJECTION N/A LABORATOIRES CIS BIOINTERNATIONAL

FRANCE

PULMOZYME AMPOULE 2.5MG/2.5ML ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

PULMOZYME INHALATIONSOLUTION 1MG/ML

INHALATION SOLUTION 1MG/ML ROCHE PRODUCTSLIMITED

UNITED KINGDOM

PULSATE TABLETS 150MG SAMI PAKISTAN

PULVO 47 POWDER FOR TOPICALAPPL.

2.10(7) CU/100G LABORATOIRESFOURNIER SCA

FRANCE

PULVO 47 NEOMYCIN POWDER FOR TOPICALAPPL.

N/A LABORATOIRESFOURNIER SCA

FRANCE

PUMP-HEP SOLUTION FORINJECTIONS

1000IU/ML LEO LABORATORIESLIMITED

UNITED KINGDOM

PURFALOX CAPSULE 200MG KLEVA LTD GREECE

PURI-NETHOL TABLETS 50MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

PURI-NETHOL TABLETS 50MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

PUVADIN 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

PYLORID TABETS 400MG COATED TABLET 400MG GLAXO GROUP LTD UNITED KINGDOM

PYOPEN INJECTION 1G POWDER FOR INJECTION 1G BEECHAM GROUP PLC UNITED KINGDOM

PYOPEN INJECTION 5G POWDER FOR INJECTION 5G BEECHAM GROUP PLC UNITED KINGDOM

PYRALVEX BUCCAL & GINGIVALGEL

N/A NORGINE PHARMA FRANCE

PYRALVEX GEL FOR ORAL MUCOSA N/A NORGINE PHARMA FRANCE

PYRALVEX SOLUTION N/A NORGINE LIMITED UNITED KINGDOM

EL684 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PYRALVEX GEL N/A NORGINE PHARMA FRANCE

PYRAZINAMIDE TABLETS 500MG PHARMAMED LTD. MALTA

PYRCOST CAPSULE 20MG KLEVA LTD GREECE

PYRCOST SUPPOSITORY 20MG KLEVA LTD GREECE

PYRCOST GEL 0.5% W/W KLEVA LTD. GREECE

PYRIDOXINE HYDROCHLORIDE50MG TABLETS BP

TABLET 50 MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

PYRIDOXINE TABLETS BP 50MG TABLETS 50MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

PYRIDOXINE TABLETS BP 50MG TABLETS 50MG NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

PYRIDOXINE-10 TABLET TABLET 10MG CAMDEN INDUSTRIES (M)SDN. BHD.

MALAYSIA

QUADRASA POWDER FOR RECTALSOL.

2G NORGINE PHARMA FRANCE

QUIET LIFE TABLETS COATED TABLET N/A G R LANE HEALTHPRODUCTS LTD

UNITED KINGDOM

QUINIMAX 125MG SCORED FILM-COATEDTABLET

N/A SANOFI WINTHROP FRANCE

QUINIMAX 125MG/ML SOLUTION FORINJECTION

N/A SANOFI WINTHROP FRANCE

QUINIMAX 250MG/2ML SOLUTION FORINJECTION

N/A SANOFI WINTHROP FRANCE

QUINIMAX 500MG FILM-COATED TABLET N/A SANOFI WINTHROP FRANCE

QUINIMAX 500MG/4ML SOLUTION FORINJECTION

N/A LABORATOIRES SANOFIWINTHROP

FRANCE

QUININE TABLET 300MG CAMDEN INDUSTRIES(M)SDN.BHD.

MALAYSIA

QUININE DIHYDROCHLORIDE SOLUTION FORINJECTION

600MG/2ML PHARMAMEDPARENTERALS LTD.

MALTA

QUININE SULPHATE TABLETS 200MG PHARMAMED LTD. MALTA

QUININE SULPHATE TABLETS 300MG PHARMAMED LTD. MALTA

QUININE SULPHATE 300 TABLETS 300MG REMEDICA LTD CYPRUS

QUININE SULPHATE BP 300MG TABLET 300MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

QUININE SULPHATE TABLETS BP300MG

TABLETS 300MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

QUININE SULPHATE TABLETS BP300MG

COATED TABLET 300MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

QUINOCORT CREAM CREAM N/A QUINODERM LIMITED UNITED KINGDOM

QVAR 100 AEROSOL AEROSOL 100MCG 3M HEALTHCARELIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 685

Trade Name Dosage Form Dose MA Holder Country

QVAR 100 AUTOHALER AEROSOL 100MCG 3M HEALTHCARELIMITED

UNITED KINGDOM

QVAR 50 AEROSOL AEROSOL 50MCG 3M HEALTHCARELIMITED

UNITED KINGDOM

QVAR 50 AUTOHALER AEROSOL 50MCG 3M HEALTHCARELIMITED

UNITED KINGDOM

RABIVAC POWDER FOR SOL. FORINJE

N/A CHIRON BEHRING GMBH& CO

GERMANY

RADIAN B MUSCLE LOTION TOPICAL SOLUTION N/A ROCHE PRODUCTSLIMITED

UNITED KINGDOM

RADIAN MASS.CR./ASKIT MUS.RUB/RADIAN B

CREAM N/A ROCHE PRODUCTSLIMITED

UNITED KINGDOM

RALGEX CREAM N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

RALGEX FREEZE SPRAY TOPICAL SPRAY N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

RALGEX FREEZE SPRAY TOPICAL SPRAY N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

RALGEX HEAT RUB CREAM CREAM N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

RALGEX HEAT SPRAY TOPICAL SPRAY N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

RALGEX LOW ODOUR HEATSPRAY

TOPICAL SPRAY N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

RAMAXIR CAPSULES 250MG REMEDICA LTD. CYPRUS

RANIGYL TABLET 200MG RAZA MANUFACTURINGBERHAD

MALAYSIA

RANITIDINE COATED TABLET 75MG EASTERNPHARMACEUTICALSLIMITED

UNITED KINGDOM

RANITIDINE TABLETS BP FILM COATED TABLETS 75MG RANBAXY (UK) LIMITED UNITED KINGDOM

RANITINE FILMCOATED TABLETS 150MG BIOFARMA ILAC SAN.VETIC. A.S.

TURKEY

RANIVIT 150 TABLETS 150MG M/S VITAPURECORPORATION

INDIA

RANSOM GLYCERIN, LEMON ANDHONEY LINCTUS

ORAL SOLUTION N/A WILLIAM RANSOM &SON PLC

UNITED KINGDOM

RANTAC-150 TABLET 150MG UNIQUEPHARMACEUTICALLABORATORIES

INDIA

RANTIN TABLETS 150MG MACTERINTERNATIONAL (PVT)LTD.

PAKISTAN

RANTUDIL FORTE CAPSULE 60MG BAYER VITAL GMBH &CO. KG

GERMANY

RANTUDIL FORTE CAPSULES 60MG TROPON GMBH GERMANY

RANTUDIL RETARD CAPSULE 90MG BAYER VITAL GMBH &CO. KG

GERMANY

EL686 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

RANTUDIL RETARD CAPSULES 90MG TROPON GMBH GERMANY

RAPAMUNE ORAL SOLUTION 1MG/1ML WYETH-AYERSTLABORATORIES

UNITED KINGDOM

RAPAMUNE ORAL SOLUTION 1MG/ML WYETH EUROPA LTD. UNITED KINGDOM

RAPIFEN 0.5MG/ML SOLUTION FORINJECTION

0.5MG/ML JANSSEN-CILAG N.V. BELGIUM

RAPOLYTE POWDER N/A HELSINN BIREXPHARMACEUTICALS LTD.

IRELAND

RAXAR TABLETS 400MG TABLET 400MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

RAXAR TABLETS 600MG TABLET 600MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

RBC CREAM CREAM N/A RYBAR LABS. LIMITED UNITED KINGDOM

REBETOL HARD CAPSULES 200MG SP EUROPE UNITED KINGDOM

REBIF 22MCG SOLUTION FORINJECTION

22MCG/0.5ML ARES SERONO (EUROPE)LTD.

ITALY

RECOFOL EMULSION FORINFUSION

20MG/ML LEIRAS OY FINLAND

RECOFOL 10MG/ML EMULSION FOR INJEC./INFUS

10MG/ML LEIRAS OY FINLAND

RECOMBINANT HUMANERYTHROPOIETIN

INJECTION 6000IU/VIAL NANJING HUAXIN BIO-PHARMACEUTICALS LTD

REPUBLIC OF CHINA

RECOMBINANT HUMANERYTHROPOIETIN

INJECTION 3000IU/VIAL NANJING HUAXIN BIO-PHARMACEUTICALS LTD

REPUBLIC OF CHINA

RECOMBINANT HUMANERYTHROPOIETIN

INJECTION 4000IU/VIAL NANJING HUAXIN BIO-PHARMACEUTICALS LTD

REPUBLIC OF CHINA

RECOMBINANT HUMANERYTHROPOIETIN

INJECTION 2000IU/VIAL NANJING HUAXIN BIO-PHARMACEUTICALS LTD

REPUBLIC OF CHINA

RECOMBINATEANTIHAEMOPHILIC FACTOR

POWDER FOR INJECTION 250IU/VIAL BAXTER HEALTHCARELIMITED

UNITED KINGDOM

RECOMBINATE RAHF NOMINAL POWDER OR INJECTION 500IU/VIAL BAXTER HEALTHCARELIMITED

UNITED KINGDOM

RECOMBINATE RAHF NOMINAL1000IU/VIAL

POWDER FOR INJECTION 1000IU/VIAL BAXTER HEALTHCARELIMITED

UNITED KINGDOM

RECORMON PREFILLED SYRINGES PREFILLED SYRINGES 1000 IU/0.6ML ROCHEPHARMA(SCHWEIZ) LTD.

SWITZERLAND

RECORMON PREFILLED SYRINGES PREFILLED SYRINGES 4000/6000 IU ROCHEPHARMA(SCHWEIZ) LTD.

SWITZERLAND

RECORMON PREFILLED SYRINGES PREFILLED SYRINGES 2000/3000/5000 ROCHEPHARMA(SCHWEIZ) LTD.

SWITZERLAND

RECTODELT 10MG SUPPOSITORY 10MG TROMMSDORFF GMBH &CO. AG

GERMANY

RECTODELT 30MG SUPPOSITORY 30MG TROMMSDORFF GMBH &CO. AG

GERMANY

RECTODELT 5MG SUPPOSITORY 5MG TROMMSDORFF GMBH &CO. KG

GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 687

Trade Name Dosage Form Dose MA Holder Country

RECTOPLEXIL 3.3MG CHILDREN SUPPOSITORY 3.3MG LABORATOIRESTHERAPLIX

FRANCE

RECTOPLEXIL CHILDREN SUPPOSITORY 3.3MG LABORATOIRESTHERAPLIX

FRANCE

REDUCTIL HARD CAPSULE 10MG ABBOTT LABORATORIES UNITED KINGDOM

REDUCTIL HARD CAPSULE 15MG ABBOTT LABORATORIES UNITED KINGDOM

REFACTO POWDER AND SOLVENTFOR SOLUTION FORINJECTION

250IU GENETICS INSTITUTE OFEUROPE B.V.

EUROPEAN COMMUNITY

REFACTO POWDER AND SOLVENTFOR SOLUTION FORINJECTION

500IU GENETICS INSTITUTE OFEUROPE B.V.

EUROPEAN COMMUNITY

REFACTO POWDER AND SOLVENTFOR SOLUTION FORINJECTION

1000IU GENETICS INSTITUTE OFEUROPE B.V.

EUROPEAN COMMUNITY

REFRESH PLUS LUBRICANT EYE DROPS 0.5% W/V ALLERGAN UNITED STATES OFAMERICA

REGAINE 2% CUTANEOUS SOLUTION 20MG/ML PHARMACIA N.V./S.A. BELGIUM

REGAINE 2% GEL 20MG/G PHARMACIA & UPJOHNN.V / S.A

BELGIUM

REGAINE 5% CUTANEOUS SOLUTION 5% W/V PHARMACIA N.V. / S.A. BELGIUM

REGAINE EXTRA STRENGTH 5% TOPICAL SOLUTION 5% PHARMACIA LIMITED UNITED KINGDOM

REHIDRAT POWDER FOR ORALSOLUTION

N/A MONSANTO PLC T/ASEARLE

UNITED KINGDOM

REHIDRAT POWDER FOR ORALSOLUTION

NA PHARMACIA LIMITED UNITED KINGDOM

RELAXIN TABLETS 3MG MACTERINTERNATIONAL (PVT)LTD.

PAKISTAN

RELENZA 5MG/DOSE POWDER FORINHALATION

5MG/DOSE LABORATOIRE GLAXOWELLCOME

FRANCE

RELENZA ROTADISK INSUFFLATION BLISTERPACK

5MG GLAXO WELLCOMEAUSTRALIA LTD.

AUSTRALIA

RELIFEX TABLETS 500MG COATED TABLET 500MG BEECHAM GROUP PLC UNITED KINGDOM

REMEDEINE EFFERVESCENTTABLETS

EFFERVESCENT TABLET N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

REMEDEINE FORTE EFFERVESCENTTABLETS

EFFERVESCENT TABLET N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

REMEDEINE FORTE TABLETS TABLET N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

REMEDEINE TABLETS TABLET N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

REMEGEL CHEWABLE TABLET CHEWABLE TABLET 800 MG SETON PRODUCTSLIMITED

UNITED KINGDOM

REMEGEL FRESHMINT CHEWABLE TABLET 800 MG SETON PRODUCTSLIMITED

UNITED KINGDOM

REMETHAN 25 TABLETS 25MG REMEDICA LTD CYPRUS

EL688 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

REMETHAN 50 TABLETS 50MG REMEDICA LTD CYPRUS

REMICADE POW.ANDCONC.F/SOL/F/INF.

SEE REMARKS CENTOCOR B.V. UNITED KINGDOM

REMINYL ORAL SOLUTION 4MG/1ML JANSSENPHARMACEUTICA N.V.

BELGIUM

REMINYL FILM-COATED TABLETS 8MG JANSSEN CILAG SPA ITALY

REMINYL FILM COATED TABLETS 4MG JANSSEN CILAG SPA ITALY

REMINYL FILM COATED TABLETS 12MG JANSSEN CILAG SPA ITALY

REMOV GRANULE 100MG/SACHET VECCHI & C PIAMS.A.P.A.

ITALY

REMOV TABLET 100MG VECCHI & C PIAMS.A.P.A.

ITALY

REMYCIN 100 TABLETS 100MG REMEDICA LTD CYPRUS

RENITEC TABLET 10MG MERCK SHARP & DOHME PAKISTAN

RENITEC TABLET 5MG MSD PAKISTAN

RENITEC TABLET 5MG M.S.D. PAKISTAN

RENITEC 20MG TABLET 20MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

RENITEC 20MG TABLETS 20MG MSD PAKISTAN

RENITEC 5MG TABLET 5MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

RENNIE CHEWABLE TABLET N/A LABORATOIRES ROCHENICHOLAS S.A.

FRANCE

RENNIE DEFLATINE TABLET NS ROCHE PRODUCTSLIMITED

UNITED KINGDOM

RENNIE DUO ORAL SUSPENSION NS ROCHE PRODUCTSLIMITED

UNITED KINGDOM

RENNIE PEPPERMINT TABLET N/A ROCHE PRODUCTSLIMITED

UNITED KINGDOM

RENNIE RAP-EZE CHEWABLE TABLET 500MG ROCHE PRODUCTSLIMITED

UNITED KINGDOM

RENNIE SPEARMINT TABLET NS ROCHE PRODUCTSLIMITED

UNITED KINGDOM

REOPRO SOLUTION FORINJECTION

2MG/ML CENTOCOR B.V. NETHERLANDS

REPARIL GEL N GEL NA MADAUS AG GERMANY

REPLAVITE REHYDRATIONTREATMENT GRANULES

GRANULES N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

REPLENINE, (REPLENIN-VF) POWDER FOR INJECTION N/A BPL, BIO PRODUCTSLABORATORY

UNITED KINGDOM

RESCUE REMEDY (BACH) ORAL LIQUID N/A NELSON A. & CO LTD UNITED KINGDOM

RESCULA EYE DROPS 1.2MG/ML NOVARTIS ARGENTINASAICYF

ARGENTINA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 689

Trade Name Dosage Form Dose MA Holder Country

RESCULA EYE DROPS EYE DROPS 1.5MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

RESFOLIN TABLET 15MG VECCHI & C PIAMS.A.P.A.

ITALY

RESOVIST O.5 MMOL FE/ML SOLUTION FORINJECTION

1MG SCHERING AG GERMANY

RETACNYL 0.025% CREAM 0.025% LABORATOIRESGALDERMA

FRANCE

RETACNYL 0.05% CREAM 0.05% LABORATOIREGALDERMA

FRANCE

RETENS CAPSULE 100MG CHIESI WASSERMANNS.A.

SPAIN

RETENS CAPSULES 116MG CHIESI ESPANA S.A. SPAIN

RETIN A SOLUTION 1.183MG/G JANSSEN-CILAG AG SWITZERLAND

RETIN A 0.025% GEL 0.025% JANSSEN-CILAG AG SWITZERLAND

RETIN A 0.05% CREAM 0.05% JANSSEN-CILAG AG SWITZERLAND

RETITOP 0.05% CREAM 0.05% W/W LABORATOIRES ROCHE-POSAY

FRANCE

RETROVIR CAPSULES 100MG CAPSULES 100MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

RETROVIR CAPSULES 250MG CAPSULES 250MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

RETROVIR IV FOR INFUSION SOLUTION FORINJECTIONS

10MG/ML THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

RETROVIR SYRUP 50MG/5ML ORAL SOLUTION 50MG/5ML THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

REVIA TABLETS 50MG DUPONTPHARMACEUTICALSCOMPANY

UNITED STATES OFAMERICA

REVIDOX TABLET 100MG MACLEODSPHARMACEUTICALS LTD

INDIA

RHE FD TABLETS N/A MACLEODSPHARMACEUTICALS LTD

INDIA

RHESONATIV POWDER FOR INJECTION (I+II) 1250IU PHARMACIA & UPJOHNAB

SWEDEN

RHESSONATIV 1250 IU POWDER AND SOLVENT 200 MG BIOVITRUM AB

RHEUMASOL TABLETS COATED TABLET N/A PETER BLACKHEALTHCARE LTD

UNITED KINGDOM

RHINATHIOL 2% FOR CHILDRENAND INFANTS

SYRUP 2% W/V LABORATOIRESSYNTHELABO

FRANCE

RHINATHIOL 375MGEXPECTORANT

CAPSULE 375MG LABORATOIRESSYNTHELABO

FRANCE

RHINATHIOL 5% ADULTSEXPECTORANT

SYRUP 5% W/V LABORATOIRESSYNTHELABO

FRANCE

RHINATHIOL ADULTSSUGER-FREE EXPECTORANT

SYRUP 5% W/V LABORATOIRESSYNTHELABO

FRANCE

EL690 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

RHINATHIOL PROMETHAZINE SYRUP N/A LABORATOIRESSYNTHELABO

FRANCE

RHINATHIOL SUGAR-FREECHILDREN AND INFANTS

SYRUP 2% W/V LABORATOIRESSYNTHELABO

FRANCE

RHINOCAP CAPSULE N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

RHINOCORT AQUA NASAL SPRAY 50MCG/DOSE TIKA LAKEMEDEL AB SWEDEN

RHINOCORT AQUA NASAL SPRAY 32MCG/DOSE TIKA LAKEMEDEL AB SWEDEN

RHINOCORT AQUA NASAL SPRAY 64MCG/DOSE TIKA LAKEMEDEL AB SWEDEN

RHINOLAST NASAL SPRAY NASAL SPRAY 0.1% W/V ASTA MEDICA LTD UNITED KINGDOM

RHINOPRONT CAPSULES N/A HEINRICH MACK NACHF GERMANY

RHINOPRONT SPRAY SOLUTION N/A HEINRICH MACK GERMANY

RHINOPRONT SYRUP SUSPENSION N/A HEINRICH MACK NACHF GERMANY

RHINOTUSSAL CAPSULES NA HEINRICH MACK NACHF GERMANY

RHINOTUSSAL SYRUP NA HEINRICH MACK NACHF GERMANY

RHUMAGEL GEL N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

RHUMAGEL GEL N/A HOE PHARMACEUTICALSSDN BHD

MALAYSIA

RHUMAGEL GEL 0.5% W/W HOE PHARMACEUTICALSSDN. BHD

MALAYSIA

RIAMET TABLETS N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

RIBOMICIN OPHTHALMIC OINTMENT 0.3% W/W FARMIGEA SPA ITALY

RIBOMICIN OPHTHALMIC DROPS 0.3% W/V FARMIGEA SPA ITALY

RIFADINE 150MG CAPSULE 150MG LABORATOIRES MARIONMERRELL DOW

FRANCE

RIFADINE 300MG CAPSULE 300MG LABORATOIRES MARIONMERRELL DOW

FRANCE

RIFADINE LYOPHILISEE 600MG PREPARATION FORINFUSION

600MG LABORATOIRES MARIONMERRELL DOW

FRANCE

RIFAMPICIN FILM COATED TABLETS 300MG PHARMAMED LTD. MALTA

RIFAMPICIN AND ISONIAZID ANDPYRAZINAMIDE

TABLET 150/75/400MG MACLEODSPHARMACEUTICALS LTD

INDIA

RIFAMPICIN AND ISONIAZID150/100MG

TABLET N/A MACLEODSPHARMACEUTICALS LTD

INDIA

RIFAMPICIN AND ISONIAZID150/75MG

TABLET N/A MACLEODSPHARMACEUTICALS LTD

INDIA

RIFAMPICIN AND ISONIAZID300/150MG

TABLETS N/A MACLEODSPHARMACEUTICALS LTD

INDIA

RIFAMPICIN AND ISONOIAZIDAND PYRAZINAMIDE

TABLET 120/50/300MG MACLEODSPHARMACEUTICALS LTD

INDIA

RIFAMPICIN + ISONIAZID TABLETS 300MG +150MG PHARMAMED LTD. MALTA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 691

Trade Name Dosage Form Dose MA Holder Country

RIFAREN CAPSULES 300MG REMEDICA LTD. CYPRUS

RIFAREN 150 CAPSULES 150MG REMEDICA LTD CYPRUS

RIFASYNT 150MG CAPSULE 150MG MEDOCHEMIE LTD CYPRUS

RIFASYNT 300MG CAPSULE 300MG MEDOCHEMIE LTD CYPRUS

RIFATER COATED TABLET N/A LABORATOIRES MARIONMERRELL DOW

FRANCE

RIFINAH TABLETS 150MG/100MG GRUPPO LEPETIT SPA ITALY

RIFINAH 300MG/150MG COATED TABLET N/A LABORATOIRES MARIONMERRELL FRANCE

FRANCE

RIKODEINE 9.5MG/5ML ORAL LIQUID 9.5MG/5ML 3M PHARMACEUTICALSPTY LTD.

AUSTRALIA

RILCAPTON 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

RILCAPTON 50MG TABLET 50MG MEDOCHEMIE LTD CYPRUS

RILUTEK FILM COATED TABLET 50MG RHONE-POULENC RORERS.A.

FRANCE

RINGER LACTATED AGUETTANT SOLUTION FORINFUSION

N/A LABORATOIREAGUETTANT

FRANCE

RINGERS INJECTION USP SOLUTION FORINJECTION

NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

RINGER'S INJECTION USP SOLUTION FOR IVINFUSION

N/A ABBOTT LABORATORIES UNITED STATES OFAMERICA

RINGER'S IRRIGATION SOLUTION IRRIGATION SOLUTION N/A B.BRAUN MELSUNGENAG

GERMANY

RINGERS IV INFUSION SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

RINGER'S LACTATE (HARTMANNSOLUTION)

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIAFARMACEUTICA

PORTUGAL

RINSTEAD ADULT GEL OROMUCOSAL GEL N/A SCHERING-PLOUGHLIMITED

UNITED KINGDOM

RINSTEAD CONTACT PASTILLE LOZENGE 2MG SCHERING-PLOUGHLIMITED

UNITED KINGDOM

RINSTEAD SUGAR FREEPASTILLES

LOZENGE N/A SCHERING-PLOUGHLIMITED

UNITED KINGDOM

RINSTEAD TEETHING GEL ORAL GEL N/A SCHERING-PLOUGHLIMITED

UNITED KINGDOM

RIOPAN PLUS SUS SUSPENSION N/A WYETH-AYERSTCANADA INC.

CANADA

RISDONE-1 TABLET 1MG INTASPHARMACEUTICALS LTD

INDIA

RISDONE-1 (RISPERIDONETABLETS 1MG)

TABLET 1MG INTASPHARMACEUTICALS LTD

INDIA

RISDONE-2 TABLETS 2MG INTASPHARMACEUTICALS LTD

INDIA

RISDONE-2 (RISPERIDONETABLETS 2MG)

TABLET 2MG INTASPHARMACEUTICALS LTD

MALAYSIA

EL692 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

RISDONE-3 TABLET 3MG INTASPHARMACEUTICALS LTD

INDIA

RISDONE-3 (RISPERIDONETABLETS 3MG)

TABLET 3MG INTASPHARMACEUTICALS LTD

MALAYSIA

RISDONE-4 4MG TABLET INTASPHARMACEUTICALS LTD

INDIA

RISDONE-4 (RISPERIDONETABLETS 4MG)

TABLET 4MG INTASPHARMACEUTICALS LTD

INDIA

RISPERDAL 1MG TABLET 1MG JANSSEN-CILAG N.V. BELGIUM

RISPERDAL 1MG/ML ORAL SOLUTION 1MG/ML JANSSEN-CILAG AG BELGIUM

RISPERDAL 2MG TABLET 2MG JANSSEN-CILAG N.V. BELGIUM

RISPERDAL 3MG TABLET 3MG JANSSEN-CILAG N.V. BELGIUM

RITALIN TABLETS 10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

RITALIN TABLETS 10MG NOVARTIS PHARMAGMBH

GERMANY

RITOSIN FILM TABLET 150MG BIOFARMA ILAC SAN VETIC A.S.

TURKEY

RIVOTRIL TABLETS 0.5MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

RIVOTRIL TABLET 2MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

ROACCUTANE CAPSULES 2.5MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

ROACCUTANE CAPSULES 10MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

ROACCUTANE CAPSULE 20MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

ROACCUTANE 10MG CAPSULE 10MG PRODUITS ROCHE FRANCE

ROACCUTANE 20MG CAPSULE 20MG PRODUITS ROCHE FRANCE

ROACCUTANE 5MG CAPSULES 5MG PRODUITS ROCHE FRANCE

ROBITUSSIN SYRUP 100MG/5ML WHITEHALLINTERNATIONAL INC

UNITED STATES OFAMERICA

ROBITUSSIN DM SYRUP N/A WHITEHALLINTERNATIONAL INC.

UNITED STATES OFAMERICA

ROBITUSSIN DM SYRUP SYRUP NS WYETH CONSUMERHEALTHCARE

UNITED STATES OFAMERICA

ROBITUSSIN PAEDIATRIC COUGH SYRUP 7.5MG/5 ML WYETH CONSUMERHEALTHCARE

UNITED STATES OFAMERICA

ROBITUSSIN PE SYRUP N/A WHITEHALLINTERNATIONAL INC.

UNITED STATES OFAMERICA

ROBITUSSIN PE SYRUP SYRUP NA WYETH CONSUMERHEALTHCARE

UNITED STATES OFAMERICA

ROCEPHIN ROCHE VIAL 2G ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 693

Trade Name Dosage Form Dose MA Holder Country

ROCEPHIN VIALS 250MG (I.M.) STERILE POWDER FORRECONS

250MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

ROCEPHIN VIALS 500MG (I.V.) STERILE POWDER FORRECON.

500MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

ROCEPHINE 1G/10ML (IV USE) POWDER AND SOLVENTF. INJ.

1G/10ML PRODUITS ROCHE FRANCE

ROCEPHINE 1G/3.5ML (IM USE) POWDER AND SOLVENTF. INJ

1G/3.5ML PRODUITS ROCHE FRANCE

ROCEPHINE 250MG/5ML (IV USE) POWDER AND SOLVENTF. INJ.

250MG/5ML PRODUITS ROCHE FRANCE

ROCEPHINE 2G POWDER F SOLN FINFUSION

2G PRODUITS ROCHE FRANCE

ROCEPHINE 500MG/5ML (IV USE) POWDER AND SOLVENTF. INJ.

500MG/5ML PRODUITS ROCHE FRANCE

ROCEPHINE VIALS 1G I.M. / I.V. STERILE POWDER FORRECONS

1G ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

RODOGYL FILM COATED TABLET N/A RHONE-POULENC RORER FRANCE

ROFERON-A VIAL SEE CPP ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

ROKAMOL 500MG CAPLETS CAPLET 500MG TAROPHARMACEUTICALINDUSTRIES LTD

ISRAEL

ROPRIL AEGIS LTD. 12.5MG AEGIS LTD CYPRUS

ROPRIL 25 TABLETS 25MG AEGIS LTD. CYPRUS

ROPRIL 50 TABLETS 50MG AEGIS LTD. CYPRUS

ROR, TRIMOVAX, TRIMOVAXMERIEUX

SOLUTION FORINJECTION

N/A PASTEUR MERIEUXSERUMS & VACCINSLABORATORIES

FRANCE

ROVAMYCIN 1.5M IU FILM-COATED TABLETS 1.50 MILLION IU SPECIA LABORATORIES FRANCE

ROVAMYCINE FILM-COATED TABLETS 3 MILLION IU RHONE-POULENC RORER FRANCE

ROVAMYCINE FILM-COATED TABLETS 1.5 MILLION IU RHONE-POULENC RORER FRANCE

ROVAMYCINE 3 MILLION IU FILM-COATED TABLETS N/A SPECIA LABORATORIES FRANCE

ROVAMYCINE CHILDREN 0.75MIU GRANULES FOR ORALSUSPENS

0.75MIU RHONE-POULENC RORERPHARMASPECIALITES

FRANCE

ROWATANAL CREAM N/A ROWAPHARMACEUTICALS LTD

IRELAND

ROXAID TABLET 150MG UNIMEDPHARMACEUTICALS INC.

KOREA REPUBLIC

ROXAMED TABLETS 150MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

ROXITAN 10 CAPSULES 10MG REMEDICA LTD CYPRUS

ROXY — 150 TABLET 150MG CIPLA LTD INDIA

ROZEX GEL FOR CUTANEOUSUSE

0.75% W/W LABORATOIRESGALDERMA

FRANCE

EL694 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ROZEX CREAM 0.75% W/W GALDERMA(UK) LIMITED UNITED KINGDOM

ROZEX CREAM CREAM 0.75%W/W GALDERMA (UK) LIMITED UNITED KINGDOM

ROZEX GEL GEL 0.75% W/W GALDERMA (UK) LIMITED UNITED KINGDOM

RPR SULPHADIAZINE SOLUTION FORINJECTION

27.2% W/V CONCORDPHARMACEUTICALSLIMITED

UNITED KINGDOM

RREDENEMA RECTAL SOLUTION 0.2MG/ML PHARMAX LIMITED UNITED KINGDOM

RUBELLA VACCINE LIVE B.P.LYOPHILISED

FREEZE-DRIED CAKE F/INJ

1000 CCID50 M/S SERUM INSTITUTEOF INDIA

INDIA

RUBILIN RUBELLA VACCINE FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM

RUBIMYCIN TABLET 250MG PHARMACARE LIMITED SOUTH AFRICA

RUDIVAX SOLUTION FORINJECTION

N/A PASTEUR MERIEUX FRANCE

RUDOLAC SYRUP 7G/10ML G.STREULI & CO. AG SWITZERLAND

RULID TABLET 150MG HOECHST MARIONROUSSEL

PAKISTAN

RULID 100MG COATED TABLET 100MG LABORATOIRES AVENTIS FRANCE

RULID 100MG TABLET 100MG HOECHST MARIONROUSSEL

PAKISTAN

RULID 150MG TABLET 150MG LABORATOIRES AVENTIS FRANCE

RULID 150MG TABLET 150MG HOECHST MARIONROUSSEL

PAKISTAN

RULID 50MG TABLET FOR ORALSUSPEN.

50MG LABORATOIRES AVENTIS FRANCE

RUMAFEN-400 TABLETS 400MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

RUMAFEN-600 TABLETS 600MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

RUMAFEN-600 SUSPENSION 100MG/5ML ATCO LABORATORIES(PVT) LTD

PAKISTAN

RUMAFEN-600 GEL 10G/100G ATCO LABORATORIES(PVT) LTD

PAKISTAN

RUPAN 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

RUSYDE TABLETS 20MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

RUSYDE TABLETS 40MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

RUVOMINOX INJECTABLE SOLUTION 75MG/3ML RAFARM GREECE

RYNACROM 2% NASAL SPRAY ORRESISTON TWO

NASAL SPRAY 2%W/V FISONS LTD T/A RHONEPOULENC RORER

UNITED KINGDOM

RYNACROM 2% NASAL SPRAY ORRESTINON TWO

NASAL SPRAY 2% W/V FISONS LTD. T/A RHONEPOULENC RORER

UNITED KINGDOM

RYNACROM 4% NASAL SPRAY NASAL SPRAY 4% W/V FISONS LIMITED UNITED KINGDOM

RYNACROM 4% NASAL SPRAY NASAL SPRAY 4%W/V FISONS LTD UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 695

Trade Name Dosage Form Dose MA Holder Country

RYNACROM COMPOUND NASAL SPRAY N/A FISONS LIMITED T/ARHONE-POULENC RORER

UNITED KINGDOM

RYNACROM COMPOUND NASAL SPRAY(AEROSOL) N/A FISONS LTD T/A RHONE-POULENC RORER

UNITED KINGDOM

RYNACROM NASAL DROPS NASAL DROPS 2%W/V FISONS LTD T/A RHONE-POULENC RORER

UNITED KINGDOM

RYNACROM NASALDROPS/NASAL SPRAY

NASAL DROPS 2% W/V FISONS LIMITED T/ARHONE POULENC RORER

UNITED KINGDOM

RYTHMODAN CAPSULES 100MG CAPSULE 100MG HOECHST MARIONROUSSEL LIMITED

UNITED KINGDOM

RYTHMODAN INJECTION50MG/5ML

SOLUTION FORINJECTION

50MG/5ML ROUSSELLABORATORIES LTD

UNITED KINGDOM

S.C.R. CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

SABRIL 500MG TABLET 500MG LABORATOIRES MARIONMERRELL S.A.

FRANCE

SACCA CLEAR-FLEX 2000ML SOLUTION FOR DIALYSIS NA BIEFFE MEDITAL S.P.A. ITALY

SACCA CLEAR-FLEX 2000ML SOLUTION FOR DIALISYS N/A BIEFFE MEDITAL SPA ITALY

SALAMOL EASI-BREATHE INHALER 0.1MG/DOSE NORTON HEALTHCARELIMITED

UNITED KINGDOM

SALAMOL EASI-BREATHECFC-FREE

INHALER, AERSOSOL 100MCG/DOSE NORTON HEALTHCARELIMITED

UNITED KINGDOM

SALAMOL STERI-NEB 2.5MG SOLUTION FORNEBULISER

2.5MG/2.5ML STERIPAK LIMITED UNITED KINGDOM

SALAMOL STERI-NEB 5MG SOLUTION FORNEBULISATION

5MG/2.5ML STERIPAK LIMITED UNITED KINGDOM

SALAZOPYRIN TABLETS 500MG PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

SALAZOPYRIN SUPPOSITORIES 500MG PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

SALAZOPYRIN EN GASTRO-RESIS. TABLETS 500MG PHARMACIA & UPJOHN SWEDEN

SALAZOPYRIN ENEMA RECTAL SOLUTION 3%W/V PHARMACIALABORATORIES LIMITED

UNITED KINGDOM

SALBUTAMOL AEROSOL INHALATION 0.1MG/DOSE NORTON HEALTHCARELIMITED

UNITED KINGDOM

SALBUTAMOL TABLETS 4MG PHARMAMED LTD. MALTA

SALBUTAMOL TABLETS 4MG REMEDICA LTD. CYPRUS

SALBUTAMOL 2 TABLETS 2MG REMEDICA LTD CYPRUS

SALBUTAMOL SYRUP ORAL SYRUP 2MG/5ML EGYPTIANINTERNATIONALPHARMACEUTICALINDUSTRIES CO (EIPICO)

EGYPT

SALINE STERI-NEB 0.9%W/V SOLUTION (SEEREMARKS)

22.5MCG/2.5ML STERIPAK LIMITED UNITED KINGDOM

SALIPAX CAPSULES 20MG MEPHA PHARMA AG SWITZERLAND

SALMOL CFC-FREE INHALER INHALER 29.64MG NOTRON HEALTHCARELTD

UNITED KINGDOM

EL696 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SALOFALK SUPPOSITORIES 250MG DR. FALK PHARMAGMBH

GERMANY

SALOFALK ENTERIC COATEDTABLETS

500MG DR. FALK PHARMAGMBH

GERMANY

SALOFALK ENTERIC-COATEDTABLETS

250MG DR. FALK PHARM GMBH GERMANY

SALOFALK ENEMAS 4G/60ML DR. FALK PHARMAGMBH

GERMANY

SAMIXON 500 IV POWDER FOR INJECTION 500MG/VIAL HIKMAPHARMACEUTICALS

JORDAN

SANDA-100 CAPSULE 100MG OKASA PHARMA PVTLTD INDIA

INDIA

SANDA-25 CAPSULE 25MG OKASA PHARMA PVT.LTD — INDIA

INDIA

SANDIMMUM CAPSULES 100MG NOVARTIS PAKISTAN

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SANDIMMUN NEORAL ORAL SOLUTION 100MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 100MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 50MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SANDIMMUN NEORAL ORAL SOLUTION 100MG/ML NOVARTISFARMACEUTICA S.A

SPAIN

SANDIMMUN NEORAL CAPSULES 100MG NOVARTISFARMACEUTICA S.A

SPAIN

SANDIMMUN NEORAL CAPSULES 25MG NOVARTISFARMACEUTICA S.A

SPAIN

SANDOMIGRAN TABLETS 0.5MG NOVARTIS PHARMASCHWEIZ

SWITZERLAND

SANDOSTATIN SOLUTION FORINJECTION

0.1MG/ML NOVARTISFARMACEUTICA S.A

SPAIN

SANDOSTATIN SOLUTION FORINJECTION

1MG/5ML NOVARTISFARMACEUTICA S.A

SPAIN

SANDOSTATIN SOLUTION FORINJECTION

1MG/5ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SANDOSTATIN SOLUTION FORINJECTION

0.05MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SANDOSTATIN SOLUTION FORINJECTION

0.5MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SANDOSTATIN SOLUTION FORINJECTION

100MCG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SANDOSTATIN SOLUTION FORINJECTION

0.05MG/ML NOVARTISFARMACEUTICA S.A

SPAIN

SANDOSTATIN LAR MICROSPHERES FOR INJ. 10MG NOVARTIS PHARMA AG SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 697

Trade Name Dosage Form Dose MA Holder Country

SANDOSTATIN LAR MICROSPHERES FOR INJ. 20MG NOVARTIS PHARMA AG SWITZERLAND

SANDOSTATIN LAR MICROSPHERES FOR INJ. 30MG NOVARTIS PHARMA AG SWITZERLAND

SANDOSTATIN LAR POWDER FOR INJECTION 20MG NOVARTISFARMACEUTICA S.A.

SPAIN

SANDOSTATIN LAR POWDER FOR INJECTION 10MG NOVARTISFARMACEUTICA S.A

SPAIN

SANDOSTATIN LAR POWDER FOR INJECTION 30MG NOVARTISFARMACEUTICA S.A

SPAIN

SANDOSTATINA SOLUTION FORINJECTION

0.5MG/ML NOVARTIS FARMA —PRODUTOSFARMACEUTICOS S.A.

PORTUGAL

SANTE CAPSULES CAPSULES 20 MG MACTERINTERNATIONAL (PVT)

PAKISTAN

SAROTEN TABLET 10MG H. LUNDBECK A/S DENMARK

SAROTEN TABLET 25MG H.LUNDBECK A/S DENMARK

SASTID SOAP SOAP N/A STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

SAUBASIN TABLETS 60MG KLEVA LTD GREECE

SAVENTRINE IV SOLUTION FORINJECTION

2MG/2ML PHARMAX LIMITED UNITED KINGDOM

SAVOY COLD AND FLU RELIEFTABLETS

COATED TABLETS N/A NORMA CHEMICALSLIMITED

UNITED KINGDOM

SCHERIPROCT-SALBE OINTMENT N/A SCHERING WIENGESELLSCHAFT M.B.H.

AUSTRIA

SCHOLL ANTISEPTIC FOOT BALM CREAM N/A SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

SCHOLL ATHLETES FOOT TOPICAL POWDER 1% W/W SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

SCHOLL ATHLETE'S FOOT CREAM CREAM 1%W/W SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

SCHOLL ATHLETES FOOT SPRAYLIQUID

TOPICAL SPRAY 1%W/W SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

SCHOLL CALLOUS REMOVERS PLASTER 40%W/W SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

SCHOLL CORN AND CALLOUSREM. LIQ.

TOPICAL SOLUTION N/A SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

SCHOLL VERRUCA REMOVALSYSTEM

PLASTER 40%W/W SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

SCOT-TUSSIN ALLERGYSUGAR-FREE

LIQUID 12.5MG/5ML SCOT-TUSSINPHARMACAL CO., INC.

UNITED STATES OFAMERICA

SCOT-TUSSIN DM COUGHCHASERS

LOZENGE 5MG SCOT-TUSSINPHARMACAL CO INC

UNITED STATES OFAMERICA

SCOT-TUSSIN DM SUGAR-FREE LIQUID N/A SCOT-TUSSINPHARMACAL CO., INC.

UNITED STATES OFAMERICA

SCOT-TUSSIN EXPECTORANTSUGAR-FREE

LIQUID 200MG/10ML SCOT-TUSSINPHARMACAL CO., INC.

UNITED STATES OFAMERICA

EL698 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SCOT-TUSSIN ORIGINAL S-F COLDAND ALLERGY

LIQUID N/A SCOT-TUSSINPHARMACAL CO., INC.

UNITED STATES OFAMERICA

SCOT-TUSSIN SENIORSUGAR-FREE

LIQUID N/A SCOT-TUSSINPHARMACAL CO., INC.

UNITED STATES OFAMERICA

SEAL AND HEAL VERRUCAREMOVAL GEL

GEL N/A SCHOLL CONSUMERPRODUCTS LIMITED

UNITED KINGDOM

SEDOXIL PILLS 1MG MEDIBIAL — PRODUTOSMEDICOS EFARMACEUTICOS, S.A.

PORTUGAL

SEDOXIL TABLET NA LABORATORIOS BIAL —PORTELA & CA, S.A.

PORTUGAL

SEDOXIL TABLET 1MG MEDIBIAL — PRODUTOSMEDICOS EFARMACEUTICOS S.A.

PORTUGAL

SEFAGEN SOLUTION FORINJECTION

1G BILIM ILAC SANAYII VETICARET AS

TURKEY

SEKROL SYRUP NA BILIM ILAC SANAYII VETICARET AS

TURKEY

SELECIM TABLETS 5MG CIMEX AG SWITZERLAND

SELECTOL 200MG TABLET 200MG RORERPHARMACEUTICALS LTD.(T/A RHONE POULENCRORER)

UNITED KINGDOM

SELEGELINE HYDOCHLORIDE TABLETS 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SELEGELINE HYDROCHLORIDE TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SELEGILENE HCL TABLETS 5MG TEVA PHARMACEUTICALINDUSTRIES LTD.

ISRAEL

SELEGOS 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

SELEMYCIN 100MG/2ML LIQUID FOR INJECTION 100MG/2ML MEDOCHEMIE LTD CYPRUS

SELEMYCIN 250MG/2ML LIQUID FOR INJECTION 250MG/2ML MEDOCHEMIE LTD CYPRUS

SELEMYCIN 500MG/2ML LIQUID FOR INJECTION 500MG/2ML MEDOCHEMIE LTD CYPRUS

SELERIN TABLETS 5MG CIPLA LTD INDIA

SELEXID TABLETS 200MG LEO PHARMACEUTICALPRODUCTS

DENMARK

SELEXID POWDER FOR INJECTION 400G/VIAL LEO PHARMACEUTICALPRODUCTS

DENMARK

SELGIN TABLETS 5MG INTASPHARMACEUTICALS LTD.

INDIA

SELSUN SHAMPOO 2.5%W/V ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

SEMPREX CAPSULES 8MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

SENNA 7.5 TABLETS 7.5MG REMEDICA LTD CYPRUS

SENNA 7.5MG TABLET 7.5MG MEDOCHEMIE LTD CYPRUS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 699

Trade Name Dosage Form Dose MA Holder Country

SENOKOT SYRUP ORAL SOLUTION 0.18% W/W RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

SENOKOT TABLETS TABLET 7.5MG RECKITT & COLMANPRODUCTS LIMITED

UNITED KINGDOM

SEPCEN TABLETS 500MG LABORATOIRESCENTRUM

SPAIN

SEPCEN TABLETS 250MG LABORATOIRESCENTRUM

SPAIN

SEPCEN 250 TABLETS 250MG ESPECIALIDADESFARMACEUTICASCENTRUM SA

SPAIN

SEPCEN 500 TABLETS 500MG ESPECIALIDADESFARMACEUTICASCENTRUM SA

SPAIN

SEPTANEST WITH ADRENALINE SOLUTION FORINJECTION

1/200,000 LABORATOIRESSEPTODENT

FRANCE

SEPTANEST WITH ADRENALINE SOLUTION FORINJECTION

1/100,000 LABORATOIRESSEPTODONT

FRANCE

SEPTI-AID OINTMENT 10%W/W RAZA MANUFACTURINGBERHAD

MALAYSIA

SEPTOPAL CHAIN 30 BEADS ON CHAIN N/A MERCK BIOMATERIALGMBH

GERMANY

SEPTRA INJ. SOL. FOR INFUSION N/A GLAXO SMITHKLINE INC. CANADA

SEPTRA TABLETS NA GLAXOSMITHKLINE INC CANADA

SEPTRA DS TABLETS NA GLAXOSMITHKLINE INC CANADA

SEPTRIN TABLETS N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

SEPTRIN DISPERSIBLE TABLETS N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

SEPTRIN PAEDIATRIC SUSPENSION NA GLAXO WELLCOMEGMBH & CO.

GERMANY

SEPTRIN TABLETS NA THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

SEPTRIN ADULT SUSPENSION SUSPENSION N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

SEPTRIN FOR INFUSION SOLUTION FORINJECTION

N/A THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

SEPTRIN FORTE (DOUBLESTRENGTH)

TABLETS N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

SEPTRIN FORTE TABLETS TABLETS NA THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

SEPTRIN PAEDIATRIC SUSPENSION N/A THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

SEPTRIN TABLETS ADULT TABLETS NA THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

SEPTRIN TABLETS FORTE TABLETS NA GLAXOSMITHKLINEGMBH & Co

GERMANY

EL700 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SERENACE TABLET 1.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SERENACE TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SERENACE TABLET 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SERENACE CAPSULE 500MCG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SERENACE CAPSULES 0.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SERENACE TABLETS 1.5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SERENACE TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SERENITY TABLETS COATED TABLET N/A CATHAY OFBOURNEMOUTH LTD

UNITED KINGDOM

SERETIDE 100 DISKUS INHALATION POWDER N/A GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

SERETIDE 100 DISKUS INHALATION POWDERPRE-DISPENSED

NA ALLEN & HANDBURY'SLIMITED

IRELAND

SERETIDE 125 EVOHALER PRESS. INHAL.,SUSPENSION

N/A GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

SERETIDE 125 EVOHALER PRESSURISEDINHALATION

NA GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

SERETIDE 250 DISKUS INHALATION POWDER N/A GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

SERETIDE 250 DISKUS INHALATION POWDERPRE-DISPENSED

NA ALLEN & HANDBURY'SLIMITED

IRELAND

SERETIDE 250 EVOHALER PRESS. INHAL.,SUSPENSION

N/A GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

SERETIDE 250 EVOHALER PRESSURED INHALATION NA GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

SERETIDE 50 EVOHALER PRESS. INHAL.,SUSPENSION

N/A GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

SERETIDE 50 EVOHALER PRESSURISEDINHALATIONS

NA GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

SERETIDE 500 DISKUS INHALATION POWDERPRE-DISPENSED

NA ALLEN & HANDBURY'SLIMITED

IRELAND

SERETIDE DISKUS INHALATION POWDER 100MCG GLAXO WELLCOME UKLIMITED

IRELAND

SERETIDE DISKUS INHALATION POWDER 250MCG GLAXO WELLCOME UKLIMITED

IRELAND

SERETIDE DISKUS INHALATION POWDER 500MCG GLAXO WELLCOME UKLIMITED

IRELAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 701

Trade Name Dosage Form Dose MA Holder Country

SEREVENT SEE REMARKS 25MCG/DOSE LABORATOIREGLAXOSMITHKLINE

FRANCE

SEREVENT INHALER AEROSOL 25MCG/AC GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

SEREVENT INHALER INHALER 25MCG GLAXOWELLCOME PAKISTAN

SEREVENT INHALER AEROSOL 25MCG/AC GLAXO WELLCOME UKLIMITIED T/A ALLENAND HANDBURYS

UNITED KINGDOM

SEREVENT INHALER PRESSURISEDINHALATIONSUSPENSION

25UG/AC GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

SEROBID INHALER 200MD INHALER 25MCG CIPLA INDIA

SEROQUEL COATED TABLET 25MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLET 100MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLET 200MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLETS 25MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLETS 100MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLETS 200MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL PATIENT STARTERPACK

TABLET N/A ZENECA LIMITED UNITED KINGDOM

SEROXAT LIQUID 20MG/10ML ORAL SUSPENSION 2MG/ML SMITHKLINE BEECHAMPLC

UNITED KINGDOM

SEROXAT TABLETS 20MG COATED TABLET 20MG SMITHKLINE BEECHAMPLC

UNITED KINGDOM

SEROXAT TABLETS 30MG COATED TABLET 30MG SMITHKLINE BEECHAMPLC

UNITED KINGDOM

SERVEDOL TABLETS 20MG COATED TABLETS 20MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

SERVEDOL TABLETS 50MG COATED TABLETS 50MG 50MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

SERZONE TABLETS 50MG BRISTOL-MYERS SQUIBBCOMPANY

UNITED STATES OFAMERICA

SERZONE TABLETS 100MG BRISTOL-MYERS SQUIBBCOMPANY

UNITED STATES OFAMERICA

SERZONE TABLETS 150MG BRISTOL-MYERS SQUIBBCOMPANY

UNITED STATES OFAMERICA

SERZONE TABLETS 200MG BRISTOL-MYERS SQUIBBCOMPANY

UNITED STATES OFAMERICA

SERZONE TABLETS 250MG BRISTOL-MYERS SQUIBBCOMPANY

UNITED STATES OFAMERICA

SERZONE (DUTONIN) TABLETS 100MG BRISTOL-MYERS SQUIBBS.P.A

ITALY

SERZONE (DUTONIN) TABLETS 200MG BRISTOL MYERS SQUIBBS.P.A

ITALY

SETLERS ANTACID PEPPERMINT TABLETS 500MG STAFFORD MILLERLIMITED

UNITED KINGDOM

EL702 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SETLERS ANTACID SPEARMINT TABLETS 500MG STAFFORD MILLERLIMITED

UNITED KINGDOM

SETLERS ANTACID-PEPPERMINT TABLET 500MG STAFFORD-MILLERLIMITED

UNITED KINGDOM

SETLERS ANTACID-SPEARMINT TABLET 500MG STAFFORD-MILLERLIMITED

UNITED KINGDOM

SETLERS WIND-EZE CHEWABLE TABLET 125MG STAFFORD-MILLERLIMITED

UNITED KINGDOM

SETLERS WIND-EZE SOFT GEL CAPSULES 125MG STAFFORD MILLERLIMITED

UNITED KINGDOM

SETLERS WIND-EZE CHEWABLE TABLETS 125MG STAFFORD MILLERLIMITED

UNITED KINGDOM

SEVEN SEAS COD LIVER OIL ORAL SOLUTION N/A SEVEN SEAS LIMITED UNITED KINGDOM

SEVORANE INHALATION LIQUID 100% V/V ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

SEVORANE INHALATION LIQUID 100%V/V ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

SEVREDOL ORAL SOLUTION10MG/5ML

ORAL SOLUTION 10MG/5ML NAPP LABORATORIESLTD.

UNITED KINGDOM

SEVREDOL TABLETS 10MG COATED TABLETS 10MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

SEVRIN OINTMENT 30% W / W BIOGLANLABORATORIES LTD

UNITED KINGDOM

SGUARDI OPHTHALMIC DROPS 0.01G FARMIGEA SPA ITALY

SI[PROX 250 MG TABLETS TABLETS 250 MG DELTA HF ICELAND

SIBELIUM CAPSULE 5MG JANSSEN-CILAG N.V. BELGIUM

SICCAPOS GEL GEL 2MG/ML URSAPHARMARZNEIMITTEL GMBH

GERMANY

SICCAPROTECT EYE DROPS N/A URSAPHARMARZNEIMITTEL GMBH

GERMANY

SICORTEN CREAM 0.05% W/W NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SICORTEN PLUS CREAM N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SIFROL TABLETS 0.088MG BOEHRINGER INGELHEIMINTERNATIONAL GMBH

GERMANY

SIFROL TABLETS 0.18MG BOEHRINGER INGELHEIMINTERNATIONAL GMBH

GERMANY

SIFROL TABLETS 0.7MG BOEHRINGER INGELHEIMINTERNATIONAL GMBH

GERMANY

SILOMAT TABLETS 40MG BOEHRINGER INGELHEIMPHARMA KG

GERMANY

SILVER NITRATE PENCIL 95% PAD MOULDED TOUGHENEDTIP

95% SOLOPORT LIMITED T/ABRAY HEALTH & LEISURE

UNITED KINGDOM

SIMCARD-10 TABLET 10MG CIPLA LTD INDIA

SIMECO SUSPENSION N/A WYETH-LEDERLE PAKISTAN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 703

Trade Name Dosage Form Dose MA Holder Country

SIMLO-10 (SIMVASTATIN TABLETSUSP)

TABLET 10MG IPCA LABORATORIESLIMITED

INDIA

SIMPLE EYE OINTMENT BP EYE OINTMENT NO ACTIVE INGR. MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

SIMULECT POWDER FOR INJECTION 20MG/VIAL NOVARTIS PHARMA AG SWITZERLAND

SIMULECT (INJECTION)LYOPHILISATE

20MG/ VIAL NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SIMULECT SEE REMARKS 4MG/ML NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

SIMVACOR TABLETS 10MG KLEVA LTD GREECE

SIMVAKOL FILM TABLET 10MG NOBEL ILAC SANAYII VETICARET A.S.

TURKEY

SIMVOR 10MG TABLETS 10MG RANBAXY LABS LTD INDIA

SINECOD DROPS FOR CHILDREN 5MG/ML NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

SINECOD SYRUP 15MG/10ML NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

SINEMET 110MG TABLET N/A MERCK SHARP & DOHMEB.V.

NETHERLANDS

SINEMET 25/250 TABLETS 25/250MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

SINEMET CR 250MG TABLETS 250MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

SINEQUAN CAPSULE 50MG PFIZER LIMITED UNITED KINGDOM

SINEQUAN CAPSULE 25MG PFIZER LIMITED UNITED KINGDOM

SINEQUAN CAPSULE 10MG PFIZER LIMITED UNITED KINGDOM

SINEQUAN CAPSULE 75MG PFIZER LIMITED UNITED KINGDOM

SINGULAIR CHEWABLE TABLETS 4MG MERCK SHARP & DOHMELTD.

NETHERLANDS

SINGULAIR 10MG TABLETS COATED TABLET 10MG MERCK SHARP & DOHME UNITED KINGDOM

SINGULAIR PAEDIATRIC 5MG CHEWABLE TABLET 5MG MERCK SHARP & DOHME UNITED KINGDOM

SINUFED SYRUP 30MG/5ML TRIMA ISRAELPHARMACEUTICALPRODUCTS LTD

ISRAEL

SINUTAB TABLET N/A PARKE-DAVIS PAKISTAN

SINUTAB TABLET N/A PARKE-DAVIS PAKISTAN

SIOPEL CREAM CREAM N/A BIOGLANLABORATORIES LTD

UNITED KINGDOM

SIPRAZON 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

SIPROGUT GOZ DAMLASI 0.3 % OPHTHALMIC SOLUTION 0.3% BILIM ILAC SANAYII VETICARET A.S.

TURKEY

SIPROX 100 MG TABLETS TABLETS 100 MG DELTA HF ICELAND

SIPROX 500 MG TABLETS TABLET 500 MG DELTA HF ICELAND

EL704 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SIPROX 750 MG TABLET 750MG DELTA HF ICELAND

SIX PLUS PARAPED SUSPENSION ORAL SUSPENSION 250MG/5ML PINEWOODLABORATORIES LIMITEDT/A PINEWOODHEALTHCARE LIMITED

UNITED KINGDOM

SKINOREN CREAM 0.2G/G SCHERING AG ITALY

SKINOREN CREAM 20G/100G SCHERING SPA ITALY

SLOW K TABLETS TABLETS 600 MG NOVARTISPHARMACEUTICALS UKLIMITED

IRELAND

SLOW-FE MODIFIED RELEASETABLETS

160MG NOVARTISPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

SLOW-FE FOLIC MODIFIED RELEASETABLETS

N/A NOVARTISPHARMACEUTICALS UKLIMITED

UNITED KINGDOM

SLOW-K TABLETS 600MG NOVARTIS PHARMA B.V.AMHEM

NETHERLANDS

SLOW-K TABLETS 600MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SMILITENE CAPSULE 100MG RAFARM GREECE

SMILITENE CAPSULE 100MG RAFARM GREECE

SMOODERM CREAM NA DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

SNIP TABLETS N/A MEDOCHEMIE LTD CYPRUS

SNO PHENICOL EYE DROPS 0.5%W/V

EYE DROPS 0.5% W/V CHAUVINPHARMACEUTICALSLIMITED

UNITED KINGDOM

SNOWFIRE HEALING TABLETOINTMENT

OINTMENT N/A J PICKLES & SONS UNITED KINGDOM

SNUFFLEBABE VAPOUR RUB NASAL INHALATIONOINTMENT

N/A J PICKLES & SONS UNITED KINGDOM

SODAMINT BP/ SODIUMBICARBONATE COMP. BP

TABLET N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

SODIO CLORURO SOLUTION FOR IVINFUSION

0.9G/ML INDUSTRIAFARMACEUTICAGALENICA SENESE S.R.L.

ITALY

SODIO CLORURO SOLUTION FOR IVINFUSION

0.9% W/V INDUSTRIAFARMACEUTICAGALENICA SENESE S.R.L.

ITALY

SODIUM BICARBONATE TABLETS 600MG NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

SODIUM BICARBONATE CAPSULES 500MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SODIUM BICARBONATE BP ORAL MPOWDER N/A LCM LTD UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 705

Trade Name Dosage Form Dose MA Holder Country

SODIUM BICARBONATE INJMINIJET

AQUEOUS SOLUTION 4.2% W/V INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

SODIUM BICARBONATE INJMINIJET

AQUEOUS SOLUTION 8.4%W/V INTERNATIONALMEDICATION SYSTEMSLTD

UNITED KINGDOM

SODIUM BICARBONATE IV INF.POLYFUSOR BD

SOLUTION FORINJECTIONS

1.4% W/V FRESENIUS LIMITED UNITED KINGDOM

SODIUM BICARBONATE IV INF.POLYFUSOR BD

SOLUTION FORINJECTIONS

8.4%W/V FRESENIUS LIMITED UNITED KINGDOM

SODIUM BICARBONATE MINIJET SOLUTION FORINJECTION

4.2%W/V INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

SODIUM BICARBONATE MINJET SOLUTION FORINJECTION

8.4% W/V INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

SODIUM BICARBONATE TABLETS600MG

TABLETS 600MG NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

SODIUM CHLORIDE + DEXTROSE(0.9+5)%

SOLUTION FOR IVINFUSION

NA DEMA SA GREECE

SODIUM CHLORIDE + DEXTROSE(O.18 +4)%

SOLUTION F/IV INFUSION NA DEMA SA GREECE

SODIUM CHLORIDE 0.225% +GLUCOSE 5%

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

SODIUM CHLORIDE 0.45% ANDGLUCOSE 5%

SOLUTION FORINJECTION

N/A BAXTER HEALTHCARELIMITED

UNITED KINGDOM

SODIUM CHLORIDE 0.9% (5, 10OR 20ML) AMP

SOLUTION FORINJECTION

0.9% DEMO SA GREECE

SODIUM CHLORIDE 0.9%AGUETTANT

INJECTABLE SOLUTION 0.9% W/V LABORATOIREAGUETTANT

FRANCE

SODIUM CHLORIDE 0.9% DEMO SOLUTION FORINFUSION

0.9% DEMO SA GREECE

SODIUM CHLORIDE 0.9% SCHIWA SOLUTION FORINFUSION

9G/1000ML B.BRAUN MELSUNGEN GERMANY

SODIUM CHLORIDE 0.9% W/V SOL. FOR INJ./INF. 0.9%W/V PARACELCIA INDUSTRIAFARMACEUTICA S.A.

PORTUGAL

SODIUM CHLORIDE AGUETTANT INJECTABLE SOLUTION 0.9% W/V LABORATOIREAGUETTANT

FRANCE

SODIUM CHLORIDE INJECTION SOLUTION FORINJECTION

0.9%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

SODIUM CHLORIDE INJECTION SOLUTION FORINJECTION

0.9%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

SODIUM CHLORIDE INJECTIONB.P.

SOLUTION FORINJECTION

0.9% W/V PHOENIXPHARMACEUTICALSLIMITED

UNITED KINGDOM

SODIUM CHLORIDE INJECTION BP SOLUTION FORINJECTION

0.9% W/V PHOENIX PHARMA LTD UNITED KINGDOM

EL706 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SODIUM CHLORIDE INJECTION BP SOLUTION FORINJECTION

0.9% ANTIGENPHARMACEUTICALS LTD

IRELAND

SODIUM CHLORIDE INJECTION BP0.9% W/V

SOLUTION FORINJECTION

0.9% W/V MACARTHYS LABS LTD.T/A MARTINDALEPHARMACEUTICALS

UNITED KINGDOM

SODIUM CHLORIDE INJECTIONDEMO

SOLUTION FORINFUSION

0.9% DEMO SA GREECE

SODIUM CHLORIDEINJECTION/DEMO

SOLUTIO IV. INFUSION 0.9%W/V DEMO S.A. GREECE GREECE

SODIUM CHLORIDE IV INFUSION SOLUTION FORINJECTION

0.45%W/V BAXTER HEALTHCARELIMITED

UNITED KINGDOM

SODIUM CHLORIDE IV INFUSION SOLUTION FORINJECTION

0.9%W/V BAXTER HEALTHCARELIMITED

UNITED KINGDOM

SODIUM CLORIDE INJECTION SOLUTION FORINJECTION

0.9%W/V ANTIGENPHARMACEUTICALSLIMITED

IRELAND

SODIUM CROMOGLYCATE 2% EYE DROPS 2%W/W DOMINION PHARMALIMITED

UNITED KINGDOM

SODIUM IODIDE (131.I)DIAGNOSTIC CAPSULE

CAPSULE 333KBQ-3.7MBQ NYCOMED AMERSHAMPLC

UNITED KINGDOM

SODIUM NITROPRUSSIDE FOR IVINF.

POWDER FOR INJECTION 50MG/VIAL FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

SODIUM VALPROATE ENTERIC COATEDTABLETS

200MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SODIUM VALPROATE ENTERIC COATEDTABLETS

500MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SODIUM VALPROATE SUGAR FREE SOLUTION 200MG/5ML NORTON HEALTHCARELIMITED

UNITED KINGDOM

SOFRADEX EAR EYE OINTMENT EAR/EYE OINTMENT N/A ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

SOFRADEX EAR/EYE DROPS EAR/EYE DROPS N/A ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

SOFRAMYCIN EYE DROPS EYE DROPS 0.5% W/V ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

SOFRAMYCIN EYE OINTMENT0.55% W/W

OINTMENT 0.55% W/W ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

SOFRAMYCIN SKIN OINTMENT OINTMENT N/A ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

SOFRA-TULLE PAD (DRESSING) 1.05% W/W ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

SOFT CORN REMOVAL PADS PLASTER 12%W/W SCHOLL CONSUMERPRODUCTS

UNITED KINGDOM

SOLAQUIN CREAM 2% ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

SOLAQUIN FORTE CREAM 4% ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

SOLAQUIN FORTE GEL 4% ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 707

Trade Name Dosage Form Dose MA Holder Country

SOLAQUIN FORTE 4% GEL N/A ICN PHARMACEUTICALS,INC.

UNITED STATES OFAMERICA

SOLAQUIN FORTE 4% CREAM N/A ICN PHARMACEUTICALSINC.

UNITED STATES OFAMERICA

SOLARCAINE CREAM N/A SCHERING-PLOUGHLIMITED

UNITED KINGDOM

SOLARCAINE GEL GEL 0.5% W/W SCHERING-PLOUGHLIMITED

UNITED KINGDOM

SOLARCAINE LOTION TOPICAL EMULSION N/A SCHERING-PLOUGHLIMITED

UNITED KINGDOM

SOLARCAINE TOPICAL AEROSOLLIQUID SPRAY

TOPICAL SPRAY N/A SCHERING-PLOUGHLIMITED

UNITED KINGDOM

SOLCODERM SOLUTION SOL. FOR EXTERNALAPPL.

N/A SOLCO BASLE LTD. SWITZERLAND

SOLCOGYN SOLUTION SOLUTION FOR CERVIXUTERI

N/A SOLCO BASLE LTD. SWITZERLAND

SOLCOSERYL SOLUTION FOR IVINJECTION

42.5MG/ML SOLCO BASLE LTD. SWITZERLAND

SOLCOSERYL OINTMENT 2.07MG/G SOLCO BASLE LTD. SWITZERLAND

SOLCOSERYL DENTAL ADHESIVEPASTE

ORAL AND GINGIVALPASTE

2.125MG/G SOLCO BASLE LTD. SWITZERLAND

SOLCOSERYL JELLY GEL 4.15MG/G SOLCO BASLE LTD. SWITZERLAND

SOLCOTRICHOVAC POWDER FOR INJECTION 7×10(9) SOLCO BASLE LTD. SWITZERLAND

SOLEZE ANTISEPTIC CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

SOLIAN 100MG SCORED TABLET 100MG SANOFI SYNTHELABO FRANCE

SOLIAN 400MG SCORED FILM-COATEDTABLET

400MG SANOFI SYNTHELABO FRANCE

SOLOFALK SUPPOSITORIES 500MG DR.FALK PHARMA GMBH GERMANY

SOLONEX T-150 TABLET N/A MACLEODSPHARMACEUTICALS LTD

INDIA

SOLONEX T-75 TABLET N/A MACLEODS INDIA

SOLONEX-100 TABLETS 100MG MACLEODSPHARMACEUTICALS LTD

INDIA

SOLONEX-300 TABLET 300MG MACLEODSPHARMACEUTICALS LTD

INDIA

SOLPADEINE CAPSULES CAPSULE N/A SMITHKLINE BEECHAM(SWG) LTD T/A SMITHK.BEECH. CONS. HLTHC.

UNITED KINGDOM

SOLPADEINE SOLUBLE TABLETS TABLET FOR ORALSOLUTION

N/A SMITHKLINE BEECHAM(SWG) LIMITED

UNITED KINGDOM

SOLPADEINE TABLETS TABLET N/A SMITHKLINE BEECHAM(SWG) LTD T/A STERLINGHEALTH/SKB INTRNTL

UNITED KINGDOM

SOLPAFLEX TABLETS COATED TABLET N/A SMITHKLINE BEECHAMINTERNATIONAL

UNITED KINGDOM

SOLPRENE OPHTHALMIC DROPS N/A FARMIGEA SPA ITALY

EL708 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SOLU CORTEF POWDER FOR SOL FORINJ

100MG/VIAL PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

SOLUDAMIN SINGLE DOSE ORALSOLUTION

1G/SINGLE DOSE KLEVA LIMITED GREECE

SOLU-MEDROL SOLUTION FORINJECTION

500MG/VIAL PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

SOLU-MEDROL SOLUTION FORINJECTION

40MG/ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

SOLU-MEDROL SOLUTION FORINJECTION

125MG/2ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

SOLUTION INJ. DE CITRATE DEGALLIUM 67

SOLUTION FORINJECTION

74 MBQ/ML CIS BIO INTERNATIONAL FRANCE

SOLUWAX EAR DROPS 0.5% W/V HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

SOLUZIONI PER DIALISIPERITONEALE (FUN)

SOLN FOR PERITON.DIALYS.

N/A BIEFFE MEDITAL S.P.A. ITALY

SOLVIN(BROMHEXINE ELIXIR) ELIXIR 4MG/5ML IPCA LABORATORIESLIMITED

INDIA

SOMATOSTATINE UCB POWDER FOR INJECTION 3MG/ML U.C.B. S.A. BELGIUM

SOMATOSTATINE UCB LYOPHILISED FORINJECTION

250MCG UCB SA — SECTEURPHARMA

BELGIUM

SOMATOSTATIN-UCB POWDER FOR INJECTION 250MCG UCB SA BELGIUM

SOMAZINA DROPS 10G/100ML FERRERINTERNACIONAL, S.A.

SPAIN

SOMNITE SUSPENSION 2.5MG/5ML NORGINE LIMITED UNITED KINGDOM

SOMNUS COATED TABLET N/A CATHAY OFBOURNEMOUTH LTD

UNITED KINGDOM

SONA B COMPLEX TABLETS N/A SONA NUTRITION LTD. IRELAND

SONA MULTIPLUS TABLETS N/A SONA NUTRITION LTD. IRELAND

SONATA HARD CAPSULES 5MG WYETH EUROPA LTD. UNITED KINGDOM

SONATA HARD CAPSULE 10MG WYETH EUROPA LTD. UNITED KINGDOM

SOOTHAKE GEL DENTAL GEL N/A J PICKLES & SONS UNITED KINGDOM

SOOTHAKE TOOTHACHETINCTURE

DENTAL SOLUTION N/A J PICKLES & SONS UNITED KINGDOM

SOOV BITE GEL N/A EGO PHARMACEUTICALS AUSTRALIA

SOOV BURN SPRAY AEROSOL N/A EGO PHARMACEUTICALS AUSTRALIA

SOOV CREAM CREAM N/A EGO PHARMACEUTICALS AUSTRALIA

SOTALOL TABLETS 80MG TABLETS 80MG MCDERMOTTLABORATORIES LTD T/AGERARD LABORATORIES

IRELAND

SOTILEN CAPSULES 20MG MEDOCHEMIE LTD CYPRUS

SOTILEN 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 709

Trade Name Dosage Form Dose MA Holder Country

SPASMOMEN COATED TABLET 40MG A.MENARINI INDUSTRIEFARMACEUTICHERIUNITE S.R.L.

ITALY

SPASMONAL CAPSULES 60MG NORGINE LIMITED UNITED KINGDOM

SPASMONAL CAPSULES CAPSULES 60 MG NORGINE LIMITED UNITED KINGDOM

SPASMOPRIV CAPSULE 100MG POLIPHARM CO. LTD. THAILAND

SPECTRABAN ULTRA 28(SOLABAN A + B)

LOTION N/A STIEFEL LABORATORIES(UK) LTD

IRELAND

SPERSACARPINE 1% EYE DROPS 1% W/V CIBA VISION AG SWITZERLAND

SPERSACARPINE 2% EYE DROPS 2% W/V CIBA VISION AG SWITZERLAND

SPERSACARPINE 2% EYE DROPS NA NOVARTISOPHTHALMICS AG

SWITZERLAND

SPERSADEX 0.1% EYE DROPS 1MG/ML CIBA VISION AG SWITZERLAND

SPERSADEX 0.1% EYE DROPS 1.00MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

SPERSADEX COMP EYE DROPS NA NOVARTISOPHTHALMICS AG

SWITZERLAND

SPERSADEX COMP. EYE DROPS N/A CIBA VISION AG SWITZERLAND

SPERSALLERG EYE DROPS N/A CIBA VISION AG SWITZERLAND

SPERSALLERG EYE DROPS NA NOVARTISOPHTHALMICS AG

SWITZERLAND

SPERSALLERG SDU EYE DROPS N/A CIBA VISION AG SWITZERLAND

SPERSALLERG SDU EYE DROPS NA NOVARTISOPHTHALMICS AG

SWITZERLAND

SPERSANICOL EYE DROPS 5MG/ML CIBA VISION AG SWITZERLAND

SPERSANICOL EYE OINTMENT 10MG/G CIBA VISION AG SWITZERLAND

SPERSANICOL EYE DROPS 5.00MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

SPERSANICOL EYE OINTMENT 10.00MG/G NOVARTISOPHTHALMICS AG

SWITZERLAND

SPIRACTIN 25 TABLETS 25MG ALPHAPHARM PTYLIMITED

AUSTRALIA

SPIRIVA INHALATION POWDER,CAPS.

18MCG BOEHRINGER INGELHEIMPHARMA

GERMANY

SPORANOX 100MG CAPSULE 100MG JANSSEN-CILAG N.V. BELGIUM

SPORANOX ORAL SOLUTION ORAL SOLUTION 10MG/ML JANSSEN-CILAG N.V. BELGIUM

SQUA-MED SHAMPOO N/A PERMAMED AG SWITZERLAND

ST JAMES' BALM OINTMENT N/A MEDICO-BIOLOGICALLABS LTD

UNITED KINGDOM

STABILISED CERETEC POWDER FOR INJECTION 0.5MG/VIAL NYCOMED AMERSHAMPLC

UNITED KINGDOM

STABLON 12.5MG COATED TABLET 12.5MG LES LABORATOIRESSERVIER

FRANCE

EL710 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

STADELANT TABLETS 20MG CHRISPA ALFAFARMAKEYTICI S.A.

GREECE

STAMARIL SOLUTION FOR SC OR IMUSE

1000LD50/0.5ML PASTEUR MERIEUX FRANCE

STAPHYLEX CAPSULES 250MG ALPHAPHARM PTYLIMITED

AUSTRALIA

STAPHYLEX CAPSULES 500MG ALPHAPHARM PTY LTD AUSTRALIA

STAPHYLEX 250 CAPSULE 250MG ALPHAPHARM PTYLIMITED

AUSTRALIA

STAPHYLEX 500 CAPSULE 500MG ALPHAPHARM PTYLIMITED

AUSTRALIA

STAPHYLEXIN 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

STARIL TABLETS 10MG BRISTOL-MYERS SQUIBBS.P.A

ITALY

STARIL TABLETS 20MG BRISTOL-MYERS SQUIBBS.P.A

ITALY

STARLIX FILM-COATED TABLETS 60MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

STARLIX FILM-COATED TABLETS 120MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

STARLIX FILM COATED TABLETS 60MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

STARLIX FILM-COATED TABLETS 120MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

STARLIX FILM COATED TABLETS 180MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

STARLIX FILM COATED TABLETS 60MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

STARLIX FILM COATED TABLETS 120MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

STARLIX FILM COATED TABLETS 180MG NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

STAS HUSTENLOSER SAFT SOLUTION 15MG/5ML STADA OTCARZNEIMITTEL GMBH

GERMANY

STATICUM TABLET 5MG J.URIACH & CIA. S.A. SPAIN

STAVIN-30 CAPSULE 30MG OKASA PHARMAPVT.LTD-INDIA

INDIA

STAVIN-40 CAPSULE 40MG OKAS PHARMA PVT- LTD-INDIA

STAVIR-40 CAPSULES 40MG CIPLA LTD INDIA

STEDON INJECTABLE SOLUTION 10MG/2ML ADELCO S.A. GREECE

STEDON TABLET 2MG ADELCO SA GREECE

STEDON TABLET 5MG ADELCO SA GREECE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 711

Trade Name Dosage Form Dose MA Holder Country

STEDON INJ. SOLUTION 10MG/2ML ADELCO —CHROMATOURGIAATHINON E.COLOCOTRONIS BROSS.A.

GREECE

STELABID TABLET N/A SMITH KLINE &BEECHAM

PAKISTAN

STELABID TABLETS TABLETS NA SMITHKLINE BEECHAM PAKISTAN

STELAZINE TABLET 1MG SMITH KLINE &BEECHAM

PAKISTAN

STELAZINE TABLETS 1MG SMITHKLINE & BEECHAM PAKISTAN

STELAZINE SPANSULE CAPSULE2MG

MODIFIED RELEASECAPSULE

2MG GOLDSHIELDPHARMACEUTICALS LTD

UNITED KINGDOM

STELAZINE SPANSULE CAPSULES10MG

MODIFIED RELEASECAPSULE

10MG GOLDSHIELDPHARMACEUTICALSLIMITED T/AGOLDSHIELD

UNITED KINGDOM

STELAZINE SPANSULE CAPSULES15MG

MODIFIED RELEASECAPSULE

15MG GOLDSHIELDPHARMACEUTICALS LTD

UNITED KINGDOM

STELAZINE SPANSULE CAPSULES15MG

MODIFIED RELEASECAPSULE

15MG GOLDSHIELDPHARMACEUTICALSLIMITED T/AGOLDSHIELD

UNITED KINGDOM

STELAZINE SPANSULE CAPSULES2MG

MODIFIED RELEASECAPSULE

2MG GOLDSHIELDPHARMACEUTICALSLIMITED T/AGOLDSHIELD

UNITED KINGDOM

STELAZINE SYRUP SYRUP 1MG/5ML GOLDSHIELDPHARMACEUTICALSLIMITED T/AGOLDSHIELD

UNITED KINGDOM

STELAZINE TABLETS 1MG COATED TABLET 1MG GOLDSHIELDPHARMACEUTICALS LTD

UNITED KINGDOM

STELAZINE TABLETS 1MG COATED TABLET 1MG GOLDSHIELDPHARMACEUTICALSLIMITED T/AGOLDSHIELD

UNITED KINGDOM

STELAZINE TABLETS 5MG COATED TABLET 5MG GOLDSHIELDPHARMACEUTICALS LTD

UNITED KINGDOM

STELAZINE TABLETS 5MG COATED TABLET 5MG GOLDSHIELDPHARMACEUTICALSLIMITED T/AGOLDSHIELD

UNITED KINGDOM

STEMETIL TABLET 5MG RHONE POULENC PAKISTAN

STEMETIL TABLET 5MG RHONE-POULENC-RORER PAKISTAN

STEMETIL INJECTION 1.25% W/V SOLUTION FORINJECTION

1.25% W/V CASTLEMEADHEALTHCARE LIMITED

UNITED KINGDOM

STEMETIL INJECTION 1.25%W/V SOLUTION FORINJECTION

1.25%W/V CASTLEMEADHEALTHCARE LTD

IRELAND

STEMETIL TABLES 25MG TABLET 25MG CASTLEMEADHEALTHCARE LIMITED

UNITED KINGDOM

EL712 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

STEMETIL TABLETS TABLETS 5MG CASTLEMEADHEALTHCARE LTD

IRELAND

STEMETIL TABLETS TABLET 25MG CASTLEMEADHEALTHCARE LTD

IRELAND

STEMETIL TABLETS 5MG TABLET 5MG CASTLEMEADHEALTHCARE LIMITED

UNITED KINGDOM

STERETS NORMASOL TOPICAL SOLUTION 0.9% W/V SETON PREBBLESLIMITED

UNITED KINGDOM

STERETS UNISEPT TOPICAL SOLUTION 0.25% V/V SETON PREBBLESLIMITED

UNITED KINGDOM

STERIFLEX N0.5 SODIUMCHLORIDE 0.18%

SOLUTION FOR IVINFUSION

0.18% W/V FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO 10 DARR0W'SSOLUTION

SOUTION FOR INJECTION N/A FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO 11 HARTMANNSSOLUTION

SOLUTION FORINJECTION

N/A FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO 31 DEXTROSE IVINFUSION 20%

SOLUTION FOR IVINFUSION

20% W/V FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO 34 DEXTROSE IVINFUSION BP

SOLUTION FOR IVINFUSION

50% W/V FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO 42 SOLUTION FORINJECTIONS

N/A FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO 45 SODIUMCHLORIDE AND DEXT.

SOLUTION FORINJECTION

N/A FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO 6 DEXTROSE IVINF. 5%

SOLUTION FOR IVINFUSION

5% W/V FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO 7 DEXTROSE 10% SOLUTION FOR IVINFUSION

10%W/V FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO 9 RINGERSSOLUTION

SOLUTION FORINJECTIONS

N/A FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO.2 SODIUMCHLORIDE 0.45%

SOLUTION FOR IVINFUSION

0.45% W/V FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO1 SODIUMCHLORIDE 0.9%

SOLUTION FOR IVINFUSION

0.9% W/V FRESENIUS LIMITED UNITED KINGDOM

STERIFLEX NO3 SODIUMCHLORIDE AND DEXTROSE

SOLUTION FOR IVINFUSION

N/A FRESENIUS LIMITED UNITED KINGDOM

STERILE CARDIOPLEGIACONCENTRATE

SOLUTION FORINJECTION

N/A F.H. FAULDING & CO.LTD (T/A DAVID BULLLABS)

AUSTRALIA

STERILE DOBUTAMINE HCLCONCENTRATE

SOLUTION FORINJECTION

250MG/20ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

STERILE DOBUTAMINEHYDROCHLORIDE

SOLUTION FORINJECTION

250MG/IN 20ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

STERILE DOBUTAMINEHYDROCHLORIDE CONC.

SOLUTION FORINJECTION

250MG/20ML ANTIGENPHARMACEUTICALSLIMITED

IRELAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 713

Trade Name Dosage Form Dose MA Holder Country

STERILE DOPAMINE CONC.SELECTAJET

SOLUTION FORINJECTION

40MG/ML INTERNATIONALMEDICATION SYSTEMS(UK) LIMITED

UNITED KINGDOM

STERILE DOPAMINECONCENTRATE 200MG/5ML

SOLUTION FORINJECTION

200MG/5ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

STERILE DOPAMINE HCLINJECTION AMPOULE

SOLUTION FORINJECTION

200MG/5ML F.H. FAULDING & CO LTD(T/A DAVID BULL LABS)

AUSTRALIA

STERILE SODIUM CHLORIDECONC. BP 30%W/V

CONCENTRATE FORINJECTION

30%W/V MACARTHYS LABS.LIMITED T/AMARTINDALEPHARMACEUTICALS

UNITED KINGDOM

STERILE WATER FOR INJECTION SOLUTION FORINJECTION

NO ACTIVE ING. ABBOTT LABORATORIES UNITED STATES OFAMERICA

STERILE WATER FOR INJECTIONUSP

SOLUTION FORINJECTION

NA ABBOTT LABORATORIES UNITED STATES OFAMERICA

STERILE WATER FOR IRRIGATIONUSP

SOLUTION FORIRRIGATION

NO ACTIVE ING. ABBOTT LABORATORIES UNITED STATES OFAMERICA

STERWIN REAL LEMON COLDPOWDERS

POWDER FOR ORALSOLUTION

N/A SANOFI WINTHROPLIMITED

UNITED KINGDOM

STIEMYCIN 2% W/W TOPICAL SOLUTION 2% W/W STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

STIEVA-A CREAM 0.05% CREAM 0.05% THERAPEX INC. CANADA

STIEVA-A FORTE CREAM 0.1% CREAM 0.1% THERAPEX INC CANADA

STIEVAMYCIN GEL JELLY N/A STIEFEL CANADA INC CANADA

STILNOX 10MG FILM-COATED TABLET 10MG LABORATOIRESSYNTHELABO

FRANCE

STIMOL ORAL SOLUTION INSACHETS

2G LABORATOIRESBIOCODEX

FRANCE

STIMOL ORAL SOLUTION 1G/10ML LABORATOIRESBIOCODEX

FRANCE

STINGOSE PUMP SPRAYDISPENSER

TOPICAL SOLUTION 20% W/V WELLVALUE LTD UNITED KINGDOM

STOCRIN ORAL SOLUTION 30MG/ML MERCK SHARP & DOHMELIMITED

EUROPEAN COMMUNITY

STOCRIN 100MG HARD CAPSULES 100MG MERCK SHARP & DOHMELTD.

EUROPEAN COMMUNITY

STOCRIN 200MG HARD CAPSULES 200MG MERCK SHARP & DOHMELTD.(UK)

EUROPEAN COMMUNITY

STOCRIN 50MG HARD CAPSULES 50MG MERCK SHARP & DOHMELTD. (UK)

EUROPEAN COMMUNITY

STREFEN LOZENGE NA CROOKES HEALTHCARELIMITED

UNITED KINGDOM

STREPSILS LOZENGE N/A KNOLL PAKISTAN

STREPSILS COUGH LOZENGES LOZENGE 2.5MG CROOKES HEALTHCARELIMITED

UNITED KINGDOM

STREPSILS HONEY AND LEMON LOZENGE N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

EL714 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

STREPSILS MENTHOL ANDEUCALYPTUS

LOZENGE N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

STREPSILS ORIGINAL LOZENGE N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

STREPSILS PAIN RELIEF PLUS LOZENGE N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

STREPSILS PAIN RELIEF SPRAY OROMUCOSAL SPRAY 2% W/V CROOKES HEALTHCARELIMITED

UNITED KINGDOM

STREPSILS SUGAR FREELOZENGES

LOZENGE N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

STREPSILS WITH HONEY ANDLEMON

LOZENGE N/A KNOLL PAKISTAN

STREPSILS WITH VITAMIN C LOZENGE N/A KNOLL PAKISTAN

STREPSILS WITH VITAMIN C100MG

LOZENGE N/A CROOKES HEALTHCARELIMITED

UNITED KINGDOM

STREPTASE 1,500,000 DRY SUBSTANCE FORINJECT.

15 — 18MG HOECHST MARIONROUSSEL DEUTSCHLANDGMBH

GERMANY

STREPTASE 250 000 UI POWDER FORINCECTABLE SOL

250 000IU LABORATOIRESHOECHST-HOUDE

FRANCE

STREPTASE 250,000 DRY SUBSTANCE FORINJECT.

2.5 — 3MG HOECHST MARIONROUSSEL DEUTSCHLANDGMBH

GERMANY

STREPTASE 750,000 DRY SUBSTANCE FORINJECT.

7.5 — 9MG HOECHST MARIONROUSSEL DEUTSCHLANDGMBH

GERMANY

STREPTOMYCIN SULPHATEINJECTION BP

POWDER FORRECONSTITUTION

1G/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM

STRESAM CAPSULES 0.05G BIOCODEXLABORATORIES

FRANCE

STRONG 15%W/V POTASSIUMCHLORIDE SOL.73

INFUSION SOLUTIONCONCENT

15% W/V B.BRAUN MELSUNGENAG

GERMANY

STRONG CO-DANTHRAMERSUSPENSION

SUSPENSION N/A NAPP LABORATORIESLIMITED

UNITED KINGDOM

STRPTASE 750 000 UI POWDER FORINJECTABLE SOL

750 000IU LABORATOIRESHOECHST-HOUDE

FRANCE

STUD 100 DESENSITIZING SPRAYFOR MEN

CUTANEOUSSPRAY,SOLUTION

9.6% W/W POUND INTERNATIONALLTD

UNITED KINGDOM

STUGERON TABLET 25MG JANSSEN PAKISTAN

STUGERON 25MG TABLET 25MG JANSSEN-CILAG N.V. BELGIUM

STUGERON FORTE CAPSULE 75MG JANSSEN-CILAG N.V. BELGIUM

SUBCUTANEOUS CALCIPARINE SOLUTION FORSUBCUTANEOUSINJECTION

5000IU/0.2ML SANOFI-SYNTHELABO FRANCE

SUBUTEX 2MG SUBLINGUALTABLETS

SUBLINGUAL TABLET 2MG SCHERING-PLOUGHLIMITED

UNITED KINGDOM

SUBUTEX 8MG SUBLINGUALTABLETS

SUBLINGUAL TABLET 8MG SCHERING-PLOUGHLIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 715

Trade Name Dosage Form Dose MA Holder Country

SUCRALAN TABLET 1G LANNACHER HEIMITTELGMBH

AUSTRIA

SUCRALFATE TABLETS 1G TABLETS 1G NORTON HEALTHCARELIMITED

UNITED KINGDOM

SUCRANASE TABLETS 255MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

SUDAFED ELIXIR SYRUP 30MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

SUDAFED TABLETS 60MG FILM COATED TABLETS 60MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

SUDOCREM ANTISEPTIC HEALINGCREAM

CREAM N/A TOSARA PRODUCTS (UK)LTD

UNITED KINGDOM

SUFENTA 2ML AMPOULES INJECTABLE SOLUTION 0.01MG/2ML JANSSEN-CILAG N.V. BELGIUM

SULFADIAZIN-HEYL TABLETS 500MG HEYL CHEMISCH-PHARMAZEUTISCHEFABRIK GMBH & CO. KG

GERMANY

SULFADOXINE + PYRIMETHAMINE TABLETS 500MG + 25MG PHARMAMED LTD. MALTA

SULFASALAZINE-HEYL GASTRO-RESISTANT F/CTAB

500MG HEYL CHEMISCH-PHARMAZEUTISCHEFABRIK GMBH & CO KG

GERMANY

SULPHADIAZINE TABLETS BP TABLET 500MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

SULPHADIAZINE TABLETS BP500MG

TABLETS 500MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

SULPHADIMIDINE BP 500MG TABLET 500MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

SULPHAKREAM-N CREAM N/A NABIQASIM PAKISTAN

SULPIREN 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

SULPIRIDE TABLETS 200MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

SULTRIN VAGINAL CREAM N/A JANSSEN-CILAG N.V. BELGIUM

SUPER WATE ON EMULSION ORAL EMULSION N/A D D D LIMITED UNITED KINGDOM

SUPPOSTE GLICER.S.PELLEGRINO SUPPOSITORY 2.72G SYNTHELABO S.P.A. ITALY

SUPPOSTE GLICER.S.PELLEGRINO SUPPOSITORY 1.36G SYNTHELABO S.P.A. ITALY

SUPRA-VIR CREAM 5%W/W TRIMA ISRAELPHARMACEUTICALPRODUCTS LTD

ISRAEL

SUPRAVIRAN 200 TABLET 206.185MG GRUNENTHAL GMBH GERMANY

SUPRAVIRAN 250 POWDER FOR I.V.INFUSION

N/A GRUNENTHAL GMBH GERMANY

SUPRAVIRAN 400 TABLET 412.37MG GRUNENTHAL GMBH GERMANY

SUPRAVIRAN 800 TABLETS 824.74MG GRUNENTHAL GMBH GERMANY

SUPRAVIRAN CREAM CREAM N/A GRUNENTHAL GMBH GERMANY

EL716 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SUPREFACT 100MCG (1MG/ML) NASAL SOLUTION 1MG/ML LABORATOIRES AVENTIS FRANCE

SURAFEM PULVULES 20MG ELI LILLY AND COMPANY UNITED STATES OFAMERICA

SURELAX HERBAL TABLET N/A GERARD HOUSE LIMITEDT/A ENGLISH GRAINSHEALTHCARE

UNITED KINGDOM

SURGAM 200MG TABLET 200MG LABORATOIRES AVENTIS FRANCE

SURGAM 300MG SUPPOSITORY 300MG LABORATOIRESROUSSEL

FRANCE

SURGAM SA CAPSULES 300MG MODIFIED RELEASECAPSULE

300MG ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

SURGAM TABLETS 300MG TABLET 300MG ROUSSELLABORATORIES LIMITED

UNITED KINGDOM

SURGICAL SPIRIT BP TOPICAL SOLUTION 95% V/V WILLIAM RANSOM &SON PLC

UNITED KINGDOM

SURGICAL SPIRIT BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM

SURGICAL SPIRIT BP TOPICAL SOLUTION NA LCM LIMITED UNITED KINGDOM

SURMONTIL COATED TABLET 10MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL COATED TABLETS 25MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL CAPSULES 50MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL 10MG TABLETS COATED TABLET 10MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL CAPSULES 50MG CAPSULE 50MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL TABLETS 25MG COATED TABLET 25MG FUTUNA LIMITED UNITED KINGDOM

SURVANTA SUSP.ENDOTRACHEOPLM.INSTI

25MG/ML ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

SURVANTA (BERACTANT) INTRATRACHEALSUSPENSION

25MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

SURVIVE 10MG TABLETS 10MG WERRICK PAKISTAN

SUSSEX PHARMACEUTICAL COLDRELIEF CAPS.

CAPSULE N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

SUSSEX PHARMACEUTICAL HOTLEMON

POWDER N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

SUSTAC TABLETS 2.6MG PHARMAX LIMITED UNITED KINGDOM

SUSTAC MODIFIED RELEASETABLETS

6.4MG PHARMAX LIMITED UNITED KINGDOM

SUSTAC SLOW RELEASE TABLETS 2.6MG PHARMAX LIMITED UNITED KINGDOM

SUSTANON SOLUTION FORINJECTION

SEE INGREDIENTS ORGANONLABORATORIES LTD.

UNITED KINGDOM

SUSTANON 100 INJECTION SOLUTION FORINJECTION

N/A ORGANONLABORATORIES LIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 717

Trade Name Dosage Form Dose MA Holder Country

SUSTANON 250 INJECTION SOLUTION FORINJECTION

N/A ORGANONLABORATORIES LIMITED

UNITED KINGDOM

SWARM CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

SYMBICORT MITE TURBUHALER INHALATION POWDER N/A DRACO LAKEMEDEL AB SWEDEN

SYMBICORT TURBUHALER INHALATION POWDER N/A DRACO LAKEMEDEL AB SWEDEN

SYNACTHEN DEPOT AQUEOUS INJECTABLESUSP.

1MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SYNAGIS POWDER AND SOLVENTF/SOLUTION F/INJECTION

50MG ABBOTT LABORATORIESLIMITED

EUROPEAN COMMUNITY

SYNAGIS POWDER AND SOLVENTF/SOLUTION F/INJECTION

100MG ABBOTT LABORATORIESLIMITED

EUROPEAN COMMUNITY

SYNALAR GEL 0.025% W/W ZENECA LIMITED UNITED KINGDOM

SYNALAR CREAM 0.025% W/W ZENECA LIMITED UNITED KINGDOM

SYNALAR OINTMENT 0.025% W/W ZENECA LIMITED UNITED KINGDOM

SYNALAR 1 IN 4 CREAM 0.00625%W/W ZENECA LIMITED UNITED KINGDOM

SYNALAR C CREAM CREAM N/A BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALAR C OINTMENT OINTMENT N/A BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALAR CREAM CREAM 0.025% W/W BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALAR CREAM 1/10 DILUTION CREAM 0.0025% W / W BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALAR CREAM 1/4 DILUTION CREAM 0.006% W / W BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALAR GEL GEL 0.025% W / W BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALAR N CREAM N/A ZENECA LIMITED UNITED KINGDOM

SYNALAR N OINTMENT N/A ZENECA LIMITED UNITED KINGDOM

SYNALAR N CREAM CREAM N/A BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALAR N OINTMENT OINTMENT N/A BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALAR OINTMENT 0.025%W/W

OINTMENT 0.025% W / W BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALAR OINTMENT 1/4DILUTION

OINTMENT 0.006% W/W BIOGLANLABORATORIES LTD

UNITED KINGDOM

SYNALGO TABLETS 680MG GEYMONAT SPA ITALY

SYNAREL NASAL SPRAY 2MG/ML MONSANTO PLC T/ASEARLE

UNITED KINGDOM

SYNAREL NASAL SPRAY 0.2%W/V MONSANTO PLC T/ASEARLE

UNITED KINGDOM

SYNCLAR-250 TABLET 250MG CIPLA LIMITED INDIA

SYNDOL TABLET N/A MARION MERRELL LTD UNITED KINGDOM

EL718 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SYNDOL CAPLETS TABLET NA SETON PRODUCTSLIMITED

UNITED KINGDOM

SYNPHASE TABLET N/A MONSANTO PLC T/ASEARLE

UNITED KINGDOM

SYNTOCINON SOLUTION FORINJECTION

10IU/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SYNTOCINON SOLUTION FORINJECTION

10IU NOVARTISFARMACEUTICA S.A

SPAIN

SYNTOMETRINE SOLUTION FORINJECTION

N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

SYNTOMETRINE SOLUTION FORINJECTION

NA NOVARTISPHARMACEUTICALS UKLIMITED

IRELAND

SYNTOMYCIN 250MG CAPSULE 250MG CODAL SYNTO LTD CYPRUS

SYNTONOL 40MG TABLET 40MG CODAL SYNTO LTD CYPRUS

SYREA CAPSULE 500MG MEDAC GMBH GERMANY

SYSCOR CC MODIFIED RELEASETABLETS

10MG BAYER PLC UNITED KINGDOM

SYSTEN 50 (EVOREL) PATCH 3.2MG JANSSEN-CILAG AG SWITZERLAND

SYSTRAL CREAM N/A ASTA MEDICA GERMANY

SYTRON 27.5MG IRON PER 5ML ORAL SOLUTION 190MG/5ML LINK PHARMACEUTICALSLIMITED

UNITED KINGDOM

T & C SHAMPOO LOTION N/A HOE PHARMACEUTICALSSDN. BHD.

MALAYSIA

TAB. AMLODIPINE BESYLATE TABLETS 5MG MACLEODS INDIA

TABROGYL TABLET 200MG TABROS PAKISTAN

TADENAN 50MG CAPSULE 50MG LABORATOIRES DEBAT FRANCE

TAGAMET INJECTABLE SOLUTION 200MG/2ML VIANEX S.A GREECE

TAGAMET TABLET 200MG SMITH KLINE &BEECHAM

PAKISTAN

TAGAMET 400 TABLET 400MG SMITH KLINE &BEECHAM

PAKISTAN

TAGAMET 400MG TABLETS COATED TABLET 400MG SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

TAGAMET INJECTION 200MG/2ML SOLUTION FORINJECTION

200MG/2ML SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

TAGAMET SYRUP 4% W/V ORAL SOLUTION 4% W/V SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

TAGAMET TABLETS 200MG COATED TABLET 200MG SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

TAGAMET TABLETS 800MG COATED TABLET 800MG SMITHKLINE & FRENCHLABORATORIES LIMITED

UNITED KINGDOM

TALCO MENTOLATO CUTANEOUS POWDER 125G LABORATORIO CHIMICOFARMACEUTICO A.SELLA S.R.L

ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 719

Trade Name Dosage Form Dose MA Holder Country

TAMAGON FORTE TABLET 120MG MEDOCHEMIE LTD CYPRUS

TAMBOCOR TABLET 100MG 3M HEALTH CARELIMITED

UNITED KINGDOM

TAMBOCOR TABLETS 100 MG 3 M HEALTH CARELIMITED

UNITED KINGDOM

TAMIFEN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

TAMIFEN DS TABLET 20MG MEDOCHEMIE LTD CYPRUS

TAMIFLU CAPSULE 75MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

TAMOFEN TABLET 10MG LEIRAS PAKISTAN

TAMOFEN TABLET 25MG LEIRAS PAKISTAN

TAMOFEN 20MG TABLETS 20MG LEIRAS OY FINLAND

TAMOXIFEN TABLETS 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

TAMOXIFEN TABLETS 20MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

TAMOXIFEN TABLETS 40MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

TAMOXIFEN TABLETS 10MG,20MG DOUGLASPHARMACEUTICALS LTD

NEW ZEALAND

TAMOXIFEN 10MG TABLET 10MG CODAL SYNTO LTD CYPRUS

TAMOXIFEN CITRATE TABLETS BP TABLETS 20MG GENERICS (UK) LTD. UNITED KINGDOM

TAMOXIFEN TABLETS BP 10MG TABLETS 10MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

TAMOXIFEN TABLETS BP 10MG COATED TABLET 10 MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

TAMOXIFEN TABLETS BP 20MG TABLETS 20MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

TAMOXIFEN TABLETS BP 20MG TABLET 20MG CP PHARMACEUTICALSLTD

UNITED KINGDOM

TAMOXIFEN TABLETS BP 40MG TABLETS 40MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

TAMPOVAGAN PESSARY N/A CO-PHARMA LIMITED UNITED KINGDOM

TANTUM ACTIV GOLA,COLLUTORIO

COLLUTTORIO 0.25% AZ. CHIM. RIUN.ANGELINI FRANCESCOACRAF SPA — ITALY

ITALY

TANTUM VERDE DENTAL PASTA DENTIFRICIA NA AZ. CHIM. RIUN.ANGELINI FRANCESCOACRAF SPA — ITALY

ITALY

TANTUM VERDE P, PASTIGLIA PASTIGLIA 3MG AZ. CHIM. RIUN.ANGELINI FRANCESCOACRAF SPA — ITALY

ITALY

TANTUM VERDE, COLLUTTORIO120ML

COLLUTTORIO 120ML NA AZ. CHIM. RIUN.ANGELINI FRANCESCOACRAF SPA — ITALY

ITALY

EL720 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TANTUM VERDE, COLLUTTORIO240ML

COLLUTTORIO 240ML NA AZ. CHIM. RIUN.ANGELINI FRANCESCOACRAF SPA — ITALY

ITALY

TARGET GEL GEL 3% W/W CYANAMID UNITED KINGDOM

TARGOCID 200MG POWDER FOR INJECTION 200MG LABORATOIRES MARIONMERRELL DOW S.A.

FRANCE

TARGOSID POWDER FOR IMINJECTION

200MG GRUPPO LEPETIT SPA ITALY

TAROCTYL TABLETS 25MG TAROPHARMACEUTICALINDUSTRIES LTD.

ISRAEL

TAROCTYL INJECTION SOLUTION FORINJECTION

50MG/2ML TAROPHARMACEUTICALINDUSTRIES LTD.

ISRAEL

TAROCTYL INJECTION 50MG/2ML SOLUTION FORINJECTION

25MG/ML TAROPHARMACEUTICALINDUSTRIES LTD

ISRAEL

TARODENT MOUTHWASH MOUTHWASH 0.2% W/V TAROPHARMACEUTICALINDUSTRIES LTD.

ISRAEL

TAVANIC 250MG COATED TABLET 250MG LABORATOIRES AVENTIS FRANCE

TAVANIC 500MG COATED TABLET 500MG LABORATOIRES AVENTIS FRANCE

TAVANIC 5MG/ML SOLUTION FORINFUSION

5MG/ML LABORATOIRESROUSSEL DIAMANT

FRANCE

TAVER 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

TAXOL INJECTABLE SOLUTION 30MG/5ML BRISTOL-MYERS SQUIBBEESTI AS

ESTONIA

TAXOL SOLN. FOR I.V INFUSION 30MG/5ML BRISTOL MYERS SQUIBBS.P.A

ITALY

TAXOTERE CONCENTRATE FORINFUSION

20MG/0.5ML RHONE-POULENCRORER(FRANCE)

EUROPEAN COMMUNITY

TAXOTERE CONCENTRATE FORINFUSION

80MG/2ML RHONE-POULENCRORER(FRANCE)

EUROPEAN COMMUNITY

TAXOTERE (DOCETAXEL) 20MG CONCENTRATE FORINFUSION

N/A RHONE-POULENC RORERS.A.

FRANCE

TAXOTERE (DOCETAXEL) 80MG CONCENTRATE FORINFUSION

N/A RHONE-POULENC RORERS.A.

FRANCE

TAZOCIN POWDER FOR INJECTION 2.25G CYANAMID OF GREATBRITAIN LTD

UNITED KINGDOM

TAZOCIN POWDER FOR INJECTION 4.5G CYANAMID OF GREATBRITAIN LTD

UNITED KINGDOM

TAZOCIN INJ. 2.25G POWDER FOR INJECTION N/A CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

TAZOCIN INJ. 4.5G POWDER FOR INJECTION N/A CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

TCK 1 KIT SOLUTION FORINJECTION

N/A CIS BIO INTERNATIONAL FRANCE

TCK-7 KIT POWDER FOR INJECTION N/A CIS BIO INTERNATIONAL FRANCE

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 721

Trade Name Dosage Form Dose MA Holder Country

TCP LIQUID ANTISEPTIC LIQUID ANTISEPTIC N/A UNICLIFFE LIMITED T/APFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

TCP FIRST AID ANTISEPTICCREAM

CREAM N/A PFIZER LIMITED UNITED KINGDOM

TCP OINTMENT OINTMENT N/A UNICLIFFE LIMITED T/APFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

TCP SORE THROAT LOZENGES LOZENGE N/A UNICLIFFE LIMITED T/APFIZER CONSUMERHEALTHCARE

UNITED KINGDOM

TD-PUR SUSPENSION FORINJECTION

NA CHIRON BEHRING GMBH& CO.

GERMANY

TEARS NATURALE FORTE LUBRICANT EYE DROPS N/A ALCON LABORATORIESINC

UNITED STATES OFAMERICA

TEARS NATURALE II/ADEQUAD EYE DROPS N/A S.A. ALCON-COUVREURN.V.

BELGIUM

TEE TREE AND WITCH HAZELCREAM

CREAM N/A GR LANE HEALTHPRODUCTS LIMITED

UNITED KINGDOM

TEEJEL GEL GEL N/A MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

TEFAMIN SUPPOSITORY 360MG RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

TEFAMIN COATED TABLET 200MG RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

TEGRAL TABLET 200MG NOVARTIS PAKISTAN

TEGRETOL TABLETS 200MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TEGRETOL TABLET 200MG GEIGY PAKISTAN

TEGRETOL SYRUP 100MG/5ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TEGRETOL SYRUP 20MG/ML NOVARTIS FARMA —PRODUTOSFARMACEUTICOS S.A.

PORTUGAL

TEGRETOL DRINKABLE SUSPENSION 100MG/5ML NOVARTIS PHARMA S.A. FRANCE

TEGRETOL TABLETS 200MG NOVARTIS FARMA —PRODUTOSFARMACEUTICOS S.A.

PORTUGAL

TEGRETOL TABLETS 200MG NOVARTIS FARMA SPA ITALY

TEGRETOL CR S.R. FILM COATEDTABLETS

200MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TEGRETOL CR S.R. FILM COATEDTABLET

400MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TEGRETOL CR DIVISIBLE TABLETS 400MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TEGRETOL CR PROLONGED RELEASETABLETS

200MG NOVARTIS FARMA —PRODUTOSFARMACEUTICOS S.A.

PORTUGAL

EL722 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TEGRETOL CR PROLONGED RELEASETABLETS

200MG NOVARTIS FARMA SPA ITALY

TEGRETOL CR PROLONGED RELEASETABLETS

400MG NOVARTIS FARMA SPA ITALY

TEGRETOL SYRUP SYRUP 100MG/5ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TELAMENT PAEDIATRIC DROPS LIQUID 50MG/100ML ADCOCK INGRAM LTD SOUTH AFRICA

TELFAST 120MG COATED TABLET 120MG LABORATOIRES MARIONMERRELL S.A

FRANCE

TELFAST 120MG TABLET 120MG HOECHST MARIONROUSSEL

PAKISTAN

TELFAST 180MG COATED TABLET 180MG LABORATOIRES MARIONMERRELL S.A.

FRANCE

TELFAST 180MG TABLET 180MG HOECHST MARIONROUSSEL

PAKISTAN

TEMAZEPAM TABLETS 10MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

TEMAZEPAM TABLETS 20MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

TEMAZEPAM TABLETS 10MG TABLETS 10MG GENERICS (UK) LIMITED UNITED KINGDOM

TEMODAL CAPSULE 5MG SCHERINGCORPORATION

UNITED STATES OFAMERICA

TEMODAL CAPSULE 20MG SCHERINGCORPORATION

UNITED STATES OFAMERICA

TEMODAL CAPSULE 100MG SCHERINGCORPORATION

UNITED STATES OFAMERICA

TEMODAL CAPSULE 250MG SCHERINGCORPORATION

UNITED STATES OFAMERICA

TENOLOL (ATENOLOL TABLETSBP)

TABLET 100MG IPCA LABORATORIESLIMITED

INDIA

TENOMET 200 TABLETS 200MG REMEDICA LTD CYPRUS

TENORET TABLETS N/A ZENECA LIMITED UNITED KINGDOM

TENORETIC TABLETS N/A ZENECA LIMITED UNITED KINGDOM

TENORMIN TABLET 25MG ZENECA LIMITED UNITED KINGDOM

TENORMIN COATED TABLET 50MG ZENECA LIMITED UNITED KINGDOM

TENORMIN COATED TABLETS 100MG ZENECA LIMITED UNITED KINGDOM

TENORMIN SOLUTION FORINJECTIONS

0.05%W/V ZENECA LIMITED UNITED KINGDOM

TENORMIN 100MG TABLET 100MG ICI PAKISTAN

TENORMIN 25MG TABLETS 25MG ICI PAKISTAN

TENORMIN 25MG TABLETS FILM COATED TABLET 25MG ZENECA LIMITED UNITED KINGDOM

TENORMIN 50MG TABLET 50MG ICI PAKISTAN

TENORMIN TABLETS 100MG COATED TABLET 100MG ZENECA LIMITED UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 723

Trade Name Dosage Form Dose MA Holder Country

TERACYCLINE BP 250MG TABLET 250MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

TERFENADINE TABLETS 60MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

TERIL 200MG TABLETS TABLET 200MG TAROPHARMACEUTICALINDUSTRIES LTD

ISRAEL

TERNOLOL FILM-COATED TABLET 100MG HOVID SDN BHD MALAYSIA

TERRA-CORTIL OINTMENT N/A PFIZER LIMITED UNITED KINGDOM

TERRA-CORTRIL NYSTATIN CREAM N/A PFIZER LIMITED UNITED KINGDOM

TERRAMYCIN CAPSULES 250MG PFIZER LIMITED UNITED KINGDOM

TERRAMYCIN TABLET 250MG PFIZER LIMITED UNITED KINGDOM

TERRAMYCIN + POLYMYXIN B OPHTALMIC OINTMENT N/A PFIZER SA BELGIUM

TERRAMYCIN+POLYMYXIN B TOPICAL OINTMENT N/A PFIZER SA BELGIUM

TESTOSTERONE IMPLANT 100MG IMPLANT (SUB-CUTAN.USE)

100MG ORGANONLABORATORIES LIMITED

UNITED KINGDOM

TESTOVIRON DEPOT 250 SOLUTION FORINJECTION

250MG SCHERING HEALTH CARELIMITED

UNITED KINGDOM

TESTOVIRON-DEPOT-250 OILY SOLN. FOR IMINJEC.

250MG/ML SCHERING AG GERMANY

TETANUS ANTITOXIN B.P. 1500IU SOLUTION FORINJECTION

1500IU M/S SERUM INSTITUTEOF INDIA LIMITED

INDIA

TETANUS TOXOID VACCINEADSORBED

SOLUTION FORINJECTION

=>40IU M/S SERUM INSTITUTEOF INDIA LIMITED

INDIA

TETANUS VACCINE (ADSORBED) SOLUTION FORINJECTION

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

TETAVAX SUSP F INJ PREFILLED SYR 40IU/0.5ML AVENTIS PASTEUR S.A FRANCE

TETAVAX SUSP F INJ IN VIAL 40IU/0.5ML AVENTIS PASTEUR S.A FRANCE

TETAVAX ADSORBEDANTI-TETANUS VACCINE

INJECTABLE SUSPENSION 40IU/VACCINE PASTEUR MERIEUX FRANCE

TETMOSOL SOAP 5% W/W ZENECA LIMITED UNITED KINGDOM

TETRACOQ INJECTABLE SUSPENSION N/A PASTEUR MERIEUX FRANCE

TETRACT HIB SUSPENSION FORINJECTION

N/A PASTEUR MERIEUX FRANCE

TETRACYCLINE 250 CAPSULES 250MG AEGIS LTD. CYPRUS

TETRACYCLINE BP 250MG CAPSULE 250MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

TETRADAR HYDROCHLORIDE250

CAPSULE 250MG DAR AL DAWADEVELOPMENT ANDINVESTMENT CO. LTD

JORDAN

TETRALYSAL 150 CAPSULES CAPSULES 150MG GALDERMA (UK) LIMITED UNITED KINGDOM

TETRALYSAL 300 CAPSULE 300MG GALDERMA (UK) LIMITED UNITED KINGDOM

EL724 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TETRAMIL OPHTHALMIC DROPS N/A FARMIGEA SPA ITALY

TETSEPT THROAT PASTILLESFORTE

PASTILLES N/A MERZ+CO. GMBH & CO. GERMANY

TEVETEN 400 FILM COATED TABLET 400MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

TEVETEN 600 FILM COATED TABLET 600MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

THALAMONAL 2ML AMPOULE N/A JANSSEN-CILAG N.V. BELGIUM

THALLOUS CHLORIDE (201TL)37MB/ML

SOLUTION FORINJECTIONS

N/A NYCOMED AMERSHAMPLC

UNITED KINGDOM

THELMOX 100 TABLETS 100MG REMEDICA LTD CYPRUS

THELMOX 500 TABLETS 500MG REMEDICA LTD CYPRUS

THEO DUR TABLET 300MG RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

THEO DUR TABLET 200MG RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

THEO DUR MODIFIED RELEASETABLET

200MG RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

THEO DUR MODIFIED RELEASETABLET

300MG RECORDATI INDUSTRIACHIMICAFARMACEUTICA S.P.A.

ITALY

THERACAP 131TM CAPSULE N/A NYCOMED AMERSHAMPLC

UNITED KINGDOM

THIAMINE SOLUTION FORINJECTION

100MG/2ML PHARMAMEDPARENTERALS LTD.

MALTA

THIAMINE HYDROCHLORIDE TABLET 50MG PHARMAMED LTD. MALTA

THIOBACTIN COATED TABLET 250MG SANOFI WINTHROP FRANCE

THIOBACTIN 750MG/5ML SOLUTION FORINJECTION

750MG/5ML SANOFI WINTHROP FRANCE

THIORIDAZINE 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

THYMOGLOBULINE 5MG/ML INJECTABLEPREPARATION

5MG/ML IMTIX-SANGSTAT FRANCE

THYMOL GLYCERIN COMPOUNDBP

DENTAL SOLUTION N/A LCM LTD UNITED KINGDOM

THYROX TABLETS 0.1MG MACLEODSPHARMACEUTICALS LTD

INDIA

THYROXIN 100MCG TABLETS TABLETS 100MCG FORLEY GENERICS LTD. UNITED KINGDOM

THYROXIN 50MCG TABLETS TABLETS 50MCG FORLEY GENERICS LTD UNITED KINGDOM

THYROXINE 100 MCG TABLETS 100 MCG GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

THYROXINE 100MCG TABLET 100MCG GOLDSHIELD GROUP PLC UNITED KINGDOM

THYROXINE 50MCG TABLET 50MCG GOLDSHIELD GROUP PLC UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 725

Trade Name Dosage Form Dose MA Holder Country

THYROXINE TABLETS TABLET 25MCG CP PHARMACEUTICALSLTD

UNITED KINGDOM

THYROXINE TABLETS 100MCG TABLETS 100MCG APPROVEDPRESCRIPTION SERVICESLIMITED

UNITED KINGDOM

THYROXINE TABLETS 50MCG BP TABLETS 50MCG APPROVEDPRESCRIPTION SERVICESLIMITED

UNITED KINGDOM

THYROXINE TABLETS BP 25MICROGRAMS

TABLETS 25MCG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

THYROXINE TABLETS BP 50MCG TABLETS 50MCG MEDEVA PHARMALIMITED

UNITED KINGDOM

TICEVIS TABLETS 10MG MEDOCHEMIE LTD. CYPRUS

TICLID 250MG FILM-COATED TABLET 250MG SANOFI WINTHROP FRANCE

TIENAM 500MG POWDER FOR INFUSION 500MG MERCK SHARP & DOHMECHIBRET

FRANCE

TIENAM I.V. 250MG STERILE POWDER FORINJECT

250MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

TIGER BALM RED OINTMENT N/A HAW PAR HEALTHCARELTD

SINGAPORE

TIGER BALM WHITE OINTMENT N/A HAW PAR HEALTHCARELTD

SINGAPORE

TIGER LINIMENT TOPICAL SOLUTION N/A HAW PAR HEALTHCARELTD

SINGAPORE

TIGER MUSCLE RUB CREAM CREAM N/A HAW PAR HEALTHCARELTD

SINGAPORE

TILADE OR TILADE SYNCRONER MET. DOSE PRESS.AEROSOL

2MG/ACTUATION FISONS LIMITED T/ARHONE-POULENC RORER

UNITED KINGDOM

TILADE OR TILADE SYNCRONER AERSOL 2.0MG/ACTUATION FISONS LTDT/A RHONE-POULENC RORER

UNITED KINGDOM

TILADE PLAIN MET. DOSE PRESS.AEROSOL

2MG/ACTUATION FISONS PLC —PHARMACEUTICALDIVISION

UNITED KINGDOM

TILDIEM 100MG POWDER FORINJECTABLE SOL

100MG/VIAL LABORATOIRESSYNTHELABO

FRANCE

TILDIEM 25MG POWDER FORINJECTABLE SOL

25MG/VIAL LABORATOIRESSYNTHELABO

FRANCE

TILDIEM 60MG TABLET 60MG LABORATOIRESSYNTHELABO

FRANCE

TILIDON FILM COATED TABLET 10MG PT INTERBAT INDONESIA

TILIDON SYRUP 5MG/5ML PT INTERBAT INDONESIA

TILIDON FILM-COATED TABLET 10MG PT INTERBAT INDONESIA

TILIDON SYRUP SYRUP 60MG PT INTERBAT INDONESIA

TIMABAK 0.25% COLLYRE (5ML) EYEDROPS 0.25% LABORATOIRES THEA FRANCE

TIMABAK 0.50% COLLYRE (5ML) EYE DROPS 0.50% LABORATOIRES THEA FRANCE

TIMENTIN 0.8G POWDER FOR INFUSION N/A BEECHAM GROUP PLC UNITED KINGDOM

EL726 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TIMENTIN 1.6G POWDER FOR INFUSION N/A BEECHAM GROUP PLC UNITED KINGDOM

TIMENTIN INJECTION 3.2G POWDER FOR INFUSION N/A BEECHAM GROUP PLC UNITED KINGDOM

TIMET 200 TABLETS 200MG AEGIS LTD. CYPRUS

TIMET 400 TABLETS 400MG AEGIS LTD. CYPRUS

TIMO-COMOD 0.5% EYE DROPS 0.5% W/V URSAPHARMARZNEIMITTEL GMBH

GERMANY

TIMOLOL EYE DROPS 0.5% W/W PL 00156/0033 UNITED KINGDOM

TIMOLOL EYE DROPS EYE DROPS 0.25% W/W NORTON HEALTHCARELIMITED

UNITED KINGDOM

TIMOLOL EYE DROPS EYE DROPS 0.5%W/V NORTON HEALTHCARELIMITED

UNITED KINGDOM

TIMOLOL MALEATE 0.25% EYE DROPS SOLUTION 0,25% EGYPTIANINTERNATIONALPHARMACEUTICALINDUSTRIES CO (EIPICO)

EGYPT

TIMOLOL MALEATE 0.5% EYE DROPS 0.5% EGYPTIANINTERNATIONALPHARMACEUTICALINDUSTRIES CO (EIPICO)

EGYPT

TIMOLOL-POS EYE DROPS 0.5% URSAPHARMARZNEIMITTEL GMBH

GERMANY

TIMOPTOL 0.25% DPS EYE DROPS 0.25% W/V MERCK SHARP & DOHMEB.V.

NETHERLANDS

TIMOPTOL 0.50% DPS EYE DROPS 0.50% W/V MERCK SHARP & DOHMEB.V.

NETHERLANDS

TIMOPTOL-XE 0.25% DPS EYE DROPS 0.25% W/V MERCK SHARP & DOHMEB.V.

NETHERLANDS

TIMOSOL EYE DROPS 0.5%W/W SEHAZOOLABORATORIES (PVT)LTD

PAKISTAN

TIMOSOL 0.5% OPHTHALMIC SOLUTION 0.5% W/V BILIM ILAC SANAYII VETICARET AS

TURKEY

TIMOSOL GOZ DAMLASI STERILE OPHTHALMICSOL'N

0.5% BILIM ILAC SANAYII VETICARET A.S.

TURKEY

TINADERM SOLUTION 10MG/ML S-P CANADA CANADA

TINADERM CREAM 1% CREAM 1% W/W SCHERING-PLOUGHLIMITED

UNITED KINGDOM

TINADERM PLUS POWDER 1% TOPICAL POWDER 1% W/W SCHERING-PLOUGHLIMITED

UNITED KINGDOM

TINADERM PLUS POWDERAEROSOL

TOPICAL SPRAY 0.09% W/W SCHERING-PLOUGHLIMITED

UNITED KINGDOM

TIRABICIN FILM-COATED TABLETS 150MG KLEVA LTD. GREECE

TIRABICIN FILM COATED TABLETS 150MG KLEVA LIMITED GREECE

TISSUCOL KIT — 2ML POWDER FOR INJECTION N/A SEE REMARKS BAXTER AG BELGIUM

TISSUCOL KIT — 0.5ML KIT (SEE REMARKS) N/A BAXTER AG BELGIUM

TISSUCOL KIT — 1ML KIT (SEE REMARKS) N/A BAXTER AG BELGIUM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 727

Trade Name Dosage Form Dose MA Holder Country

TISSUCOL KIT — 5ML POWDER FOR INJECTION N/A SEE REMARKS BAXTER EG BELGIUM

TITRALAC CHEWABLE TABLETS 420MG 3M HEALTH CARELIMITED

UNITED KINGDOM

TITRALAC CHEWABLE TABLETS 420MG 3M HEALTHCARE LTD. UNITED KINGDOM

TIXYLIX CHILDREN'S COUGHLINCTUS

ORAL SOLUTION N/A MAY & BAKER LIMITED UNITED KINGDOM

TL-201-S-1 SOLUTION FORINJECTION

37MBQ/ML CIS BIO INTERNATIONAL FRANCE

TOBRADEX OPHTHALMICSUSPENSION

N/A S.A. ALCON-COUVREURN.V

BELGIUM

TOBRADEX OPHTHALMIC OINTMENT N/A S.A ALCON-COUVREURN.V.

BELGIUM

TOBRAMYCIN SOLUTION FORINJECTION

40MG/ML BP F.H.FAULDING & CO.LIMITED (T/A DAVIDBULL LABORATORIES)

AUSTRALIA

TOBRAMYCIN INJECTION BP SOLUTION FORINJECTIONS

40MG/ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

TOBRAMYCIN INJECTION VIAL SOLUTION FORINJECTION

40MG/1ML F.H. FAULDING & CO LTD(T/A DAVID BULL LABS)

AUSTRALIA

TOBRAMYCIN SULFATEINJECTION USP

SOLUTION FORINJECTION

80MG/2ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

TOBREX OPHTHALMIC SOLUTION 3MG/ML S.A. ALCON-COUVREURN.V.

BELGIUM

TOBREX OPHTHALMIC OINTMENT 3MG/G S.A. ALCON-COUVREURN.V.

BELGIUM

TOCLASE SYRUP 15MG/10ML U.C.B. S.A. BELGIUM

TOCLASE SYRUP N/A UCB S.A. BELGIUM

TOFRANIL SUGAR COATEDTABLETS

10MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TOFRANIL SUGAR COATEDTABLETS

25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TOFRANIL TABLET 25MG GEIGY PAKISTAN

TOFRANIL SUGAR-COATEDTABLETS

25MG NOVARTIS PHARMAGMBH

AUSTRIA

TOFRANIL 25MG TABLETS 25MG NOVARTIS PAKISTAN

TOMUDEX POWDER FOR INJECTION 2MG ZENECA LIMITED UNITED KINGDOM

TON WAS 10 DRINKABLE VIALS SOLUTION FOR ORALUSE

NA CHIESI ESPANA S.A. SPAIN

TONILAX COATED TABLETS N/A LABORATOIRES MONOT FRANCE

TONOCALCIN SOLUTION FORINJECTIONS

100 IU ALFA WASSERMANNS.P.A.

ITALY

TONOCALCIN SOLUTION FORINJECTIONS

50 IU ALFA WASSERMANNS.P.A.

ITALY

TONOCEBRIN S/C TABLET N/A WALTER RITTER GMBH +CO.

GERMANY

EL728 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TOPAMAX 100MG TABLET 100MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 200MG TABLET 200MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 25MG TABLET 25MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 300MG TABLET 300MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 400MG TABLET 400MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 50MG TABLET 50MG JANSSEN-CILAG AG SWITZERLAND

TOPEX-25 TABLET 25MG CIPLA LTD INDIA

TOPTABS TABLET N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

TORBETOL ACNE LOTION TOPICAL SOLUTION N/A TORBET LABORATORIESLIMITED

UNITED KINGDOM

TORENTAL 100MG/5ML SOLUTION FORINJECTION

100MG/5ML LABORATOIRESHOECHST

FRANCE

TORENTAL LP 400MG SUSTAINED RELEASETABLET

400MG LABORATOIRESHOECHST HOUDE

FRANCE

TOSCACALM TABLETS 20MG GENEPHARM S.A. GREECE

TOSCAMYCIN-R TABLETS 150MG GENEPHARM S.A. GREECE

TOTAFORTE CAPSULE N/A DAGRA PHARMA B.V NETHERLANDS

TOTAMOL FILM COATED TABLET 50MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

TOTAMOL TABLET 25MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

TOTAMOL COATED TABLETS 100MG CP PHARMACEUTICALSLIMITED

UNITED KINGDOM

TOTAMOL TABLETS 100MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

TOTAMOL TABLETS 25MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

TOTAMOL TABLETS 50MG CP PHARMACEUTICALSLTD.

UNITED KINGDOM

TOTAMOL 25MG TABLET 25MG CP PHARMA PAKISTAN

TOTAMOL TABLET TABLET 50MG CP PHARMA P PAKISTAN

TOTAMOL TABLET TABLET 100MG CPPHARMA PAKISTAN

TOTARETIC TABLETS N/A CP PHARMACEUTICALSLTD.

UNITED KINGDOM

TOTARETIC TABLETS N/A CP PHARMACEUTICALSLTD.

UNITED KINGDOM

TOT'HEMA ORAL SOLUTION N/A LABORATOIRESINNOTHERA

FRANCE

TOT'HEMA DRINKABLE SOLUTION NA LABORATOIREINNOTECHINTERNATIONAL

FRANCE

TRACHISAN LOZENGES LOZENGE N/A KARL ENGELHARD GERMANY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 729

Trade Name Dosage Form Dose MA Holder Country

TRACHISAN SORE THROATGARGLE

SOLUTION N/A KARL ENGELHARD GERMANY

TRACHITOL LOZENGES LOZENGES N/A KARL ENGELHARD GERMANY

TRACRIUM SOLUTION FORINJECTION

SOLUTION FORINJECTION

25MG/2.5ML THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

TRACRIUM SOLUTION FORINJECTION

SOLUTION FORINJECTION

50MG/5ML THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

TRACRIUM SOLUTION FORINJECTION

SOLUTION FORINJECTION

250MG/25ML THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

TRACRIUM SOLUTION FORINJECTION

SOLUTION FORINJECTION

25MG/2.5M THE WELLCOMEFOUNDATION LTD

ITALY

TRACRIUM SOLUTION FORINJECTION

SOLUTION FORINJECTION

50MG/5ML THE WELLCOMEFOUNDATION LTD

ITALY

TRACUTIL CONCENTRATE F. SOL F.INF

N/A B.BRAUN MELSUNGENAG

GERMANY

TRAMADEX CAPSULES 50MG AEGIS LTD CYPRUS

TRAMADOL SR CAPSULES 50MG ASTA MEDICA LTD UNITED KINGDOM

TRAMADOL SR CAPSULES 100MG ASTA MEDICA LTD UNITED KINGDOM

TRAMADOL SR CAPSULE 150MG ASTA MEDICA LTD UNITED KINGDOM

TRAMADOL SR CAPSULES 200MG ASTA MEDICA LTD UNITED KINGDOM

TRAMADOL HCL CAPSULES 50MG CAPSULE 50MG SANOFI WINTHROPLIMITED T/A STERWINMEDICINES

UNITED KINGDOM

TRAMADOL HYDROCHLORIDE CAPSULES 50 MG BIOGLANLABORATORIES LTD.

UNITED KINGDOM

TRAMADOL HYDROCHLORIDECAPSULES 50MG

CAPSULE 50MG SANOFI WINTHROP LTD UNITED KINGDOM

TRAMAKE CAPSULE 50MG GALEN LIMITED UNITED KINGDOM

TRAMAL 100 SOLUTION FORINJECTION

100MG/2ML GRUNENTHAL GERMANY

TRAMAL CAPSULE CAPSULE 50MG SEARLE PAKISTAN

TRAMAL CAPSULES CAPSULES 50MG GRUNENTHAL GMBH GERMANY

TRAMAL DROPS SOLUTION 100MG/ML GRUNENTHAL GMBH GERMANY

TRAMAL RETARD 100MG FILM-COATED TABLETS 100MG GRUNENTHAL GMBH GERMANY

TRAMAL SUPPOSITORIES SUPPOSITORY 100MG GRUNENTAL GMBH GERMANY

TRAMUDIN CAPSULES CAPSULES FOR ORALUSE

50MG MUNDIPHARMA GMBH GERMANY

TRAMUDIN RETARD TABLETS100MG

RETARD TABLETS / ORALUSE

100MG MUNDIPHARMA GMBH GERMANY

TRANSACALM TABLETS 100MG LABORATOIRES A.J.C.PHARMA

FRANCE

TRANSVASIN HEAT RUB CREAM CREAM N/A SETON PRODUCTSLIMITED

UNITED KINGDOM

EL730 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TRANSVASIN HEAT SPRAY TOPICAL SPRAY N/A SETON HEALTHCAREGROUP PLC

UNITED KINGDOM

TRANXENE 10MG CAPSULE 10MG SANOFI WINTHROP FRANCE

TRANXENE 5MG CAPSULE 5MG SANOFI WINTHROP FRANCE

TRASYLOL 100,000KIU/5ML SOLUTION FORINJECTION

100,000KIU/5ML BAYER AG GERMANY

TRASYLOL 500,000KIU/50ML INFUSION SOLUTION 500,000KIU/50ML BAYER VITAL GMBH &CO. KG

GERMANY

TRAUMON GEL 100MG/G BAYER VITAL GMBH &CO. KG

GERMANY

TRAUMON GEL 100MG/1G TROPON GMBH GERMANY

TRAVATAN EYE DROPS SOLUTION 40MCG/ML ALCON LABORATORIESUK LIMITED

EUROPEAN COMMUNITY

TRAVATAN OPHTHALMICSOLUTION

OPHTHALMIC SOLUTION 0.004% ALCON UNIVERSAL LTD.C/O ALCON RESEARCHLTD

UNITED STATES OFAMERICA

TRAVILAN POWDER FOR INJECTION 1000MG ANFARM HELLAS S.A. GREECE

TRAVOCORT CREAM N/A H.E. CLISSMAN IRELAND

TRAVOCORT CREAM N/A SCHERING AG GERMANY

TRAVOCORT CREAM N/A SCHERING SPA ITALY

TRAVOCORT CREAM N/A SCHERING PAKISTAN

TRAVOCORT CREAM CREAM N/A SCHERING PAKISTAN

TRAVOGEN CREAM 10MG/G SCHERING AG GERMANY

TRAVOGEN CREAM 1MG/100G SCHERING SPA ITALY

TRAVOGEN CREAM CREAM 10MG/G SCHERING PAKISTAN

TRAVOGEN CREAM CREAM 10MG/10G SCHERING PAKISTAN

TREDOL 100 TABLETS 100MG AEGIS LTD. CYPRUS

TREDOL 25 TABLETS 25MG AEGIS LTD. CYPRUS

TREDOL 50 TABLETS 50MG AEGIS LTD. CYPRUS

TRIACANA TABLET 0.35MG LABORATORIES LAPHAL FRANCE

TRIAMCO TABLETS N/A NORTON HEALTHCARELIMITED

UNITED KINGDOM

TRIATEC 2.5MG CAPSULE 2.5MG LABORATOIRESHOECHST

FRANCE

TRIATEC 5MG CAPSULE 5MG LABORATOIRESHOECHST

FRANCE

TRIATEC FAIBLE 1.25MG CAPSULE 1.25MG LABORATOIRESHOECHST

FRANCE

TRIDIL SOLUTION FOR IVINFUSION

5MG/ML FAULDING PUERTO RICOINC

UNITED STATES OFAMERICA

TRIENE CREAM 5G/100G ALFA WASSERMANNS.P.A.

ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 731

Trade Name Dosage Form Dose MA Holder Country

TRIFLUOPERAZINE TABLETS 1MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

TRIFLUOPERAZINE TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

TRIFLUOPERAZINE 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

TRIFLUOPERAZINE 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

TRIHERPINE EYE DROPS 10MG/ML CIBA VISION AG SWITZERLAND

TRIHERPINE EYE OINTMENT 10MG/G CIBA VISION AG SWITZERLAND

TRIIODOTHYRONINE POWDER FOR INJECTION 20 MCG GOLDSHIELD GROUP PLCT/A GOLDSHIELDPHARMACEUTICALS

UNITED KINGDOM

TRIIODOTHYRONINE INJECTION20MCG

POWDER FOR INJECTION 2MCG GOLDSHIELDPHARMACEUTICALSLIMITED

UNITED KINGDOM

TRILEPTAL FILM COATED TABLETS 150MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TRILEPTAL FILM COATED TABLETS 300MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TRILEPTAL FILM COATED TABLETS 600MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TRILEPTAL ORAL SUSPENSION N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

TRIMETABOL SOLUTION ORAL SUSPENSION N/A J.URIACH & CIA. S.A. SPAIN

TRIMIDAR M ORAL SUSPENSION NA DAR AL DAWADEVELOPMENT ANDINVESTMENT CO LTD

JORDAN

TRINORDIOL TABLETS NA JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES

UNITED KINGDOM

TRINORDIOL TABLETS N/A JOHN WYETH ANDBROTHER LIMITED T/AWYETH LABORATORIES— UK

UNITED KINGDOM

TRINORDIOL 21 COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY

TRINOVIN TABLET 200MG NOVOGENLABORATORIES PTY LTD

AUSTRALIA

TRISEQUENS FORTE -28 TABLETS TABLET NA NOVO NORDISK A/S DENMARK

TRISEQUENS-28TABLETS TABLET NA NOVO NORDISK A/S DENMARK

TRITANRIX SUSPENSION FORINJECTION

N/A SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

TRITANRIX HEPB SUSPENSION FORINJECTION

NA SMITHKLINE BEECHAMBIOLOGICALS S.A.

EUROPEAN COMMUNITY

TRIVASTAL RETARD 50 SUST. REL. COATEDTABLET

50MG LES LABORATOIRESSERVIER

FRANCE

TRIVAX-AD SOLUTION FORINJECTION

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

TRIVEDON-20 TABLET 20MG CIPLA LIMITED INDIA

EL732 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TRIZOLIN 400 TABLETS 400MG REMEDICA LTD CYPRUS

TROBICIN SUSPENSION FORINJECTION

2G/3.2ML PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

TROFOGIN CREAM VAGINAL N/A FARMIGEA SPA -ITALY ITALY

TROPEX EAR DROPS 5% W/V ROWAPHARMACEUTICALS LTD

IRELAND

TROPIMIL OPHTHALMIC DROPS 0.5G/100ML FARMIGEA SPA ITALY

TROPIXAL EYE DROPS SOLUTION 0.5% W/V DEMO ABEE GREECE

TRUSOPT 2% OPHTHALMIC SOLUTION 2% W/V MERCK SHARP & DOHMEB.V.

NETHERLANDS

TRYPTANOL TABLET 10MG M.S.D. PAKISTAN

TRYPTANOL TABLET 25MG M.S.D. PAKISTAN

TRYPTIZOL 10MG TABLET 10MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

TRYPTIZOL 25MG TABLET 25MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

TUBERCULIN PPD DILUTIONSMANTOUX

SOLUTION FORINJECTIONS

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

TUBERCULIN PPD DILUTIONSMANTOUX

SOLUTION FORINJECTION

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

TUBERCULIN PPD RT 23 SSI SOLUTION FORINJECTION

2T.U./0.1ML STATENS SERUMINSTITUT

DENMARK

TUBERCULIN PPD UNDILUTEDHEAF

SOLUTION FORINJECTION

N/A EVANS MEDICAL LIMITED UNITED KINGDOM

TUBERCULIN PPD UNDILUTEDMANTOUX

SOUTION FOR INJECTION N/A EVANS MEDICAL LIMITED UNITED KINGDOM

TUBERSOL TUBERCULINPPD(MANTOUX)

LIQUID FOR INJECTION N/A AVENTIS PASTEURLIMITED

CANADA

TULOTRACT LIQUID 66,7G/100ML ARDEYPHARM GMBH GERMANY

TUPAST FILM COATED TABLETS 150MG KLEVA LTD. GREECE

TUPAST FILM COATED TABLETS 150MG KLEVA LIMITED GREECE

TUPAST FILM COATED TABLETS 300MG KLEVA LIMITED GREECE

TUSCALMAN BERNA DROPS N/A SWISS SERUM ANDVACCINE INSTITUTEBERNE

SWITZERLAND

TUSCALMAN BERNA SYRUP N/A SWISS SERUM ANDVACCINE INSTITUTEBERNE

SWITZERLAND

TUSCALMAN BERNA A SUPPOSITORIES N/A SWISS SERUM ANDVACCINE INSTITUTEBERNE

SWITZERLAND

TUSCALMAN BERNA B SUPPOSITORIES N/A SWISS SERUM ANDVACCINE INSTITUTEBERNE

SWITZERLAND

TWINRIX PAEDIATRIC SUSPENSION FORINJECTION

N/A SMITHKLINE BEECHAMBIOLOGICALS S.A.

BELGIUM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 733

Trade Name Dosage Form Dose MA Holder Country

TWINRIX-ADULT SUSPENSION FORINJECTION

N/A SMITHKLINE BEECHAMBIOLOGICALS S.A.

EUROPEAN COMMUNITY

TYLENOL DROPS 100MG/ML JANSSEN-CILAG AG SWITZERLAND

TYLENOL 100MG SUPPOSITORY 100MG JANSSEN-CILAG AG SWITZERLAND

TYLENOL 200MG SUPPOSITORY 200MG JANSSEN-CILAG AG SWITZERLAND

TYLENOL 350MG SUPPOSITORY 350MG JANSSEN-CILAG AG SWITZERLAND

TYLENOL FORTE CAPLET 500MG JANSSEN-CILAG AG SWITZERLAND

TYLENOL FORTE TABLET 500MG JANSSEN-CILAG AG SWITZERLAND

TYPHERIX SOLUTION FORINJECTION

50MCG/ML SMITHKLINE BEECHAMPLC

UNITED KINGDOM

TYPHERIX SOLUTION FORINJECTION

25MCG/0.5ML SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

TYPHIM VI SOLUTION FORINJECTION

0.025MG/0.5ML PASTEUR MERIEUX FRANCE

TYPOFEN TABLETS N/A KLEVA LTD. GREECE

TYPOFEN TABLETS N/A KLEVA LTD GREECE

TYROCOMBIN OINTMENT N/A SYNPHARMA AG SWITZERLAND

TYROCOMBIN POWDER N/A SYNPHARMA AG SWITZERLAND

TYROSUR OINTMENT N/A KARL ENGELHARD GERMANY

TYROSUR POWDER POWDER 1MG/G KARL ENGELHARD GERMANY

UBRETID TABLETS 5MG NYCOMED AUSTRIAGMBH

AUSTRIA

UFEXIL TABLETS 250MG DEMO ABEE GREECE

UFEXIL SOLUTION FORINJECTION

200MG/100ML DEMO ABEE GREECE

UFEXIL SOLUTION FORINFUSION

100MG/50ML DEMO ABEE GREECE

UKIDAN 100'000IU POWDER FOR INJECTION N/A LABORATOIRES SERONOSA

SWITZERLAND

ULCERAN 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS

ULCESEP TABLETS 20MG ESPECIALIDADESFARMACEUTICASCENTRUM SA

SPAIN

ULCESEP TABLETS 20MG LABORATOIRESCENTRUM

SPAIN

ULCOMET 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

ULCOMET 300MG/2ML LIQUID FOR INJECTION 300MG/2ML MEDOCHEMIE LTD CYPRUS

ULTAC-150 TABLET 150MG CIPLA LIMITED INDIA

ULTICADEX TABLET 5MG RAFARM GREECE

ULTICADEX TABLET 20MG RAFARM GREECE

ULTIVA FOR INJECTION1MG/VIAL

POWDER FOR INJECTION 1MG/ML GLAXO GROUP LIMITED UNITED KINGDOM

EL734 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ULTIVA FOR INJECTION2MG/VIAL

POWDER FOR INFUSION 2MG GLAXO GROUP LIMITED UNITED KINGDOM

ULTIVA FOR INJECTION5MG/VIAL

POWDER FOR INFUSION 5MG GLAXO GROUP LIMITED UNITED KINGDOM

ULTRACORTENOL EYE DROPS 5MG/ML CIBA VISION AG SWITZERLAND

ULTRACORTENOL EYE DROPS 5.00MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

ULTRALAN TABLET 20MG SCHERING AG GERMANY

ULTRALAN TABLET 5MG SCHERING AG GERMANY

ULTRATARD HM SUSPENSION FORINJECTION

100IU/ML NOVO NORDISK A/S DENMARK

ULTRAVIST-240 SOLN. FOR IV INJEC./INFUS

498.72MG/ML SCHERING AG GERMANY

ULTRAVIST-300 SOLN. FOR IV INJEC./INFUS

623.4MG/ML SCHERING AG GERMANY

ULTRAVIST-370 SOLN. FOR IV INJ./INFUS 768.86MG/ML SCHERING AG GERMANY

UMAN ALBUMIN SOLUTION FORINFUSION

20% FARMA BIAGINI S.P.A ITALY

UMODER TABLETS 100MG RAFARM GREECE

UNIBUTOL TABLETS 400MG KOREA UNITED PHARM.INC.

KOREA REPUBLIC

UNICAP M TABLET N/A UPJOHN PAKISTAN

UNICAP M TABLETS N/A PHARMACIA & UPJOHNLTD.

UNITED KINGDOM

UNIDERM CREAM 2%W/W RAZA MANUFACTURINGBERHAD

MALAYSIA

UNIFLU TABLETS; GREGOVITE 'C'TABLETS

COATED TAB;CHEWABLE TAB.

N/A UNIGREG LIMITED UNITED KINGDOM

UNIMED CHLORAMPHENICOLSOLUTION

EYE DROPS 5MG/ML UNIMEDPHARMACEUTICALS INC.

KOREA REPUBLIC

UNIMED CIPROFLOXACIN TAB. TABLET 250MG UNIMEDPHARMACEUTICALS INC.

KOREA REPUBLIC

UNIMED GENTAMICIN SULFATEEYEDROPS

EYEDROPS 3MG/ML UNIMEDPHARMACEUTICALS INC.

KOREA REPUBLIC

UNIPARIN FORTE SOLUTION FORINJECTION

10000IU/0.4ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

UNIPARIN-CA 5000IU/0.2ML SOLUTION FORINJECTION

25000IU/ML CP PHARMACEUTICALSLTD

UNITED KINGDOM

UNIPHYLLIN CONTINUS TABLETS200MG

MODIFIED RELEASETABLET

200MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

UNIPHYLLIN CONTINUS TABLETS300MG

MODIFIED RELEASETABLET

300MG NAPP LABORAOIESLIMITED

UNITED KINGDOM

UNIPHYLLIN CONTINUS TABLETS400MG

MODIFIED RELEASETABLET

400MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

UNIPLATIN (CARBOPLATIN) SOLUTION FORINJECTION

10MG/ML UNIMEDPHARMACEUTICALS INC.

KOREA REPUBLIC

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 735

Trade Name Dosage Form Dose MA Holder Country

UNIROID-HC OINTMENT OINTMENT N/A UNIGREG LIMITED UNITED KINGDOM

UNIROID-HC SUPPOSITORIES SUPPOSITORY N/A UNIGREG LIMITED UNITED KINGDOM

UPRIMA SUBLINGUAL TABLETS NA ABBOTT LABORATORIESLIMITED

UNITED KINGDOM

UPSA BUFFERED EFF. ASPIRINWITH VIT. C

SCORED EFF. TABLETS N/A LABORATOIRES UPSA FRANCE

UPSA C EFFERVESCENT TABLETS EFFERVESCENT TABLETS 1000MG LABORATOIRES UPSA FRANCE

URACTONUM 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

URAMOX TABLETS 250MG TAROPHARMACEUTICALINDUSTRIES LTD.

ISRAEL

URAMOX 250MG TALETS TABLET 250MG TAROPHARMACEUTICALINDUSTRIES LTD

ISRAEL

URBANYL TABLET 10MG HOECHST MARIONROUSSEL S.A.

TUNISIA

URDOX TABLETS 300MG COATEDTABLETS

300MG TABLETS CP PHARMACEUTICALSLTD

UNITED KINGDOM

URIGON E.C. TABLETS 25MG DEMO ABEE GREECE

URIGON SOLUTION FORINJECTION

75MG/3ML DEMO ABEE GREECE

URISPAS 200 COATED TABLET 200MG SHIREPHARMACEUTICALS LTD

UNITED KINGDOM

URITAB TABLETS 100MG RAZA MANUFACTURINGBERHAS

MALAYSIA

UROKINASE 10 000 HS MEDAC POWDER F/SOLUTIONFOR INJ

10 000 HS MEDAC GESELLSCHAFTFUR KLINISCHESPEZIALPRAPARATE MBH

GERMANY

UROKINASE 100 000 HS MEDAC POWDER F/SOLUTIONFOR INJ

100 000 HS MEDAC GESELLSCHAFTFUR KLINISCHESPEZIALPRAPARATE MBH

GERMANY

UROMITEXAN SOLUTION FORINJECTION

400MG/4ML ASTA MEDICA GERMANY

UROTRACTIN CAPSULE 400MG POLIPHARM CO. LTD. THAILAND

UROVIDEO SOLUTION FOR IVINFUSION

60% W/V BRACCO S.P.A. ITALY

URSOFALK CAPSULES 250MG DR. FALK PHARMAGMBH

GERMANY

URSOGAL CAPSULES 250MG GALEN LIMITED UNITED KINGDOM

URSOGAL TABLETS 150MG GALEN LIMITED UNITED KINGDOM

UTABON ADULTS NASAL SPRAY,SOLUTION

50MG/100ML J.URIACH & CIA. S.A. SPAIN

UTABON CHILDREN NASAL DROPS,SOLUTION 25MG/100ML J.URIACH & CIA. S.A. SPAIN

UTOVLAN TABLET 5MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

UTOVLAN TABLETS 5MG MONSANTO PLC T/ASEARLE

UNITED KINGDOM

EL736 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

UTROGESTAN 100MG SOFT CAPSULE 100MG BESINS INTERNATIONAL FRANCE

UZIX INJECTABLE SOLUTION 500MG/2ML RAFARM GREECE

VACCIN BCG INSTITUT MERIEUX SOLUTION FORINJECTION

N/A PASTEUR MERIEUX FRANCE

VACCIN POLIOMYELITIQUE ORAL ORAL SOLUTION N/A LABORATORIESPASTEUR MERIEUX

FRANCE

VACONTIL 2MG CAPSULE 2MG MEDOCHEMIE LTD CYPRUS

VACONTIL 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

VAFLUSON KETOCONAZOLE 200MG KLEVA LTD GREECE

VAGIFEM -15 APPLICATORS WITHINSERTS

TABLET 25UG NOVO NORDISK A/S DENMARK

VAGILEN VAGINAL PESSARY 500MG FARMIGEA S.P.A. ITALY

VAGILEN CAPSULE 250MG FARMIGEA SPA ITALY

VAGISIL MEDICATED CREME CREAM 2%W/W COMBE INTERNATIONALLIMITED

UNITED KINGDOM

VAGOCLYSS SOLUTION (VAGINALDOUCHE)

10MG/ML DR.GROSSMANN AGPHARMACA

SWITZERLAND

VALERIAN COMPOUND TABLETS COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

VALERIANA SCHIAPPARELLI COATED TABLETS 100MG ALFA WASSERMANNS.P.A.

ITALY

VALERIANA SCHIAPPARELLI COATED TABLETS 100MG ALFA WASSERMANNS.P.A.

ITALY

VALIREM TABLET 50MG GENEPHARM S.A GREECE

VALIUM 2MG TABLET 2MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

VALIUM 5MG TABLET 5MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

VALIUM ROCHE 2MG TABLETS 2MG PRODUITS ROCHE FRANCE

VALIUM ROCHE 5MG TABLETS 5MG LABORATOIREPRODUITS ROCHE

FRANCE

VALLERGAN FORTE SYRUP SYRUP 0.6%W/V CASTLEMEADHEALTHCARE LIMITED

UNITED KINGDOM

VALLERGAN FORTE SYRUP SYRUP 0.6%W/V CASTLEMEADHEALTHCARE LTD

IRELAND

VALLERGAN SYRUP SYRUP 0.15% W/V CASTLEMEADHEALTHCARE

IRELAND

VALLERGAN SYRUP 0.15%W/V SYRUP 0.15%W/W CASTLEMEADHEALTHCARE LIMITED

UNITED KINGDOM

VALOID INJECTION (CYCLIZINELACTATE INJ.

SOLUTION FORINJECTION

50MG/ML THE WELLCOMEFOUDATION LIMITED

UNITED KINGDOM

VALORAN 1G POWDER FOR INJECTION 1G MEDOCHEMIE LTD CYPRUS

VALPROL-EC-500 TABLETS 500MG INTASPHARMACEUTICALS LTD.

INDIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 737

Trade Name Dosage Form Dose MA Holder Country

VALTREX FILM-COATED TABLETS 500MG WELLCOMEFARMACEUTICA S.A.

SPAIN

VALTREX TABLETS 500MG COATED TABLETS 500MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

VAMIN 18 ELECTROLYTE FREE SOLUTION FORINFUSION

N/A FRESENIUS KABI LIMITED UNITED KINGDOM

VAMIN 9 GLUCOSE SOLUTION FORINFUSION

N/A FRESENIUS KABI LIMITED UNITED KINGDOM

VAMIN 9 GLUCOSE SOLUTION FORINFUSION

NA FRESENIUS KABI LIMITED UNITED KINGDOM

VAMIN-GLUKOS INTRAVENOUS INFUSION N/A PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

VANCOCIN CAPSULE 125MG ELI LILLY & COMPANY UNITED KINGDOM

VANCOMICINA COMBINO PHARM POWDER FOR IV 500MG COMBINO PHARM SL SPAIN

VANCOMYCIN CP LILLY 500 POWDER FOR INFUSION 500,000IU LILLY DEUTSCHLANDGMBH

GERMANY

VANCOMYCIN INJECTION POWDER FOR INJECTION 500MG F.H. FAULDING & CO LTD(T/A DAVID BULL LABS)

UNITED KINGDOM

VANCOMYCINE MERCK 500MG POWDER FOR IVPERFUSION

500MG / VIAL MERCK GENERIQUES FRANCE

VANCOX POWDER FOR INJ.SOLUTION

500MG/1000MG LEMERY S.A. DE C.V. MEXICO

VANCOZINE POWDER FOR INJECTION 500MG KOREA UNITED PHARM.INC.

KOREA REPUBLIC

VARICOGEL GEL N/A ALFA WASSERMANNS.P.A.

ITALY

VARILIX POWDER FOR INJECTION >=2000PFU/0.5ML SMITHKLINE BEECHAMBIOLOGICALS

BELGIUM

VARITECT CP SOLUTION FORINTRAVENOUSADMINISTRATION

N/A BIOTEST PHARMA GMBH GERMANY

VASCOTEN 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS

VASCULIN CAPSULE 10MG GEOFMANPHARMACEUTICALS

PAKISTAN

VASEXTEN 10 MODIFIED RELEASECAPSULES

10MG YAMANOUCHI PHARMAB.V.

NETHERLANDS

VASEXTEN 20 MODIFIED RELEASECAPSULES

20MG YAMANOUCHI PHARMAB.V.

NETHERLANDS

VASOGEN CREAM N/A PHARMAX LIMITED UNITED KINGDOM

VASOPOS N EYE DROPS 0.5MG/ML URSAPHARMARZNEIMITTEL GMBH

GERMANY

VASOPRIL-20 TABLETS 20MG CIPLA LTD INDIA

VASORINIL NASAL SPRAY,SOLUTION

0.1G/100ML FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

VASOTOP TABLET 30MG CIPLA LTD. INDIA

VASOXINE SOLUTION FORINJECTION

2MG/ML THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

EL738 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VASTAREL 20MG COATED TABLET 20MG LES LABORATOIRESSERVIER

FRANCE

VASTAREL 20MG/ML ORAL SOLUTION, DROPS 20MG/ML LES LABORATOIRESSERVIER

FRANCE

VASTAREL MR MODIFIED RELEASE FCTABS

35MG LES LABORATOIRESSERVIER

FRANCE

VAXEM HIB INJECTABLE SOLUTION N/A CHIRON S.P.A. ITALY

VAXIGRIP SUSPENSION FORINJECTION

N/A AVENTIS PASTEUR S.A. FRANCE

VAXIGRIP SUSPENSION FORINJECTION

NA AVENTIS PASTEUR S.A. FRANCE

VECTARION 50MG FILM-COATED TABLETSCORED

50MG LES LABORATOIRESSERVIER

FRANCE

VECTAVIR CREAM N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VEINAMITOL POWDER FOR BOUVABLESOLN.

3500MG LABORATOIRES NEGMA FRANCE

VEINAMITOL POWDER FOR ORAL SOL 3.5G/SACHET NEGMA-LERADS FRANCE

VELBE POWDER FOR IVINJECTION

10MG LILLY FRANCE S.A. FRANCE

VENLOR-37.5 TABLETS 37.5MG CIPLA INDIA

VENOGAMMA POWDER FOR SOL FORINF.I

0.06G/ML FINNISH RED CROSSBLOOD TRANSFUSIONSERVICE

FINLAND

VENORUTON GEL 20MG/G NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

VENORUTON 300 CAPSULES 300MG NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

VENOSMINE POMATA 4%W/W GEYMONAT SPA ITALY

VENOSMINE TABLETS 450MG GEYMONAT SPA ITALY

VENTEZE SYRUP 2MG/5ML PHARMACARE LIMITED SOUTH AFRICA

VENTIDE INHALER AEROSOL N/A GLAXO WELLCOME UKLTD

UNITED KINGDOM

VENTIDE INHALER AEROSOL NA GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

VENTOLIN AEROSOL N/A GLAXO WELLCOME PAKISTAN

VENTOLIN TABLETS 2MG ALLEN & HANDBURY'SLIMITED

IRELAND

VENTOLIN EVOHALER AEROSOL 100 MCG/AC GLAXO WELLCOME UKLTD

UNITED KINGDOM

VENTOLIN EVOHALER AEROSOL 100UG/AC GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

VENTOLIN INHALER AEROSOL 100MCG ALLEN AND HANBURYLTD

UNITED KINGDOM

VENTOLIN INHALER AEROSOL INHALER 100MCG PER MDI GLAXO WELLCOME PAKISTAN

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 739

Trade Name Dosage Form Dose MA Holder Country

VENTOLIN INHALER AEROSOL 100MCG/AC ALLEN AND HANDBURYLIMITED

UNITED KINGDOM

VENTOLIN INHALER SUSPENSION 100MCG GLAXO WELLCOME SA SPAIN

VENTOLIN INJECTION SOLUTION FORINJECTION

500MCG/1ML GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

VENTOLIN INJECTION SOLUTION FORINJECTION

250MCG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

VENTOLIN INJECTION250MCG/5ML

SOLUTION FORINJECTION

0.25MG GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

VENTOLIN RESPIRATORSOLUTION

INHALATION SOLUTION 0.5% W/V GLAXO WELLCOME UKLTD

UNITED KINGDOM

VENTOLIN RESPIRATORSOLUTION

INHALATION SOLUTION 5MG/ML GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

VENTOLIN SOLN. FOR I.V.INFUSION

SOLUTION FORINJECTION

5MG GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

VENTOLIN SOLUTION FOR IVINFUSION

SOLUTION FORINJECTION

5MG/1ML GLAXO WELLCOME UKLIMITED T/A ALLENHANDBURYS

UNITED KINGDOM

VENTOLIN SYRUP ORAL SOLUTION 2MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

VENTOLIN TABLETS TABLETS 2MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

VENTOLIN TABLETS TABLETS 4MG GLAXO WELLCOME UKLIMITED T/A ALLEN ANDHANDBURYS

UNITED KINGDOM

VENTOLIN TABLETS 2MG TABLET 2MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

VENTOLIN TABLETS 2MG TABLET 2MG GLAXO WELLCOME PAKISTAN

VENTOLIN, 10 FIALE 500MCG FIALE N/A GLAXOSMITHKLINE S.P.A ITALY

VEPESID CAPSULES 100MG CAPSULES 100MG BRISTOL MYERS SQUIBBHOLDINGS LTD

UNITED KINGDOM

VEPESID CAPSULES 50MG CAPSULES 50MG BRISTOL MYERS SQUIBBHOLDINGS LTD

UNITED KINGDOM

VEPESID INJECTION 5.0ML SOLUTION FORINJECTION

100MG/5ML BRISTOL MYERS SQUIBBHOLDINGS LTD

UNITED KINGDOM

VERACOL SOLUTION FORINJECTION

500MG/VIAL DEMO ABEE GREECE

VERACOL SOLUTION FORINJECTION

1G/VIAL DEMO ABEE GREECE

VERACOL POWDER FOR INJECTION 1G/VIAL DEMO ABEE GREECE

VERAPAMIL TABLETS 40MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

VERAPAMIL TABLETS 80MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

EL740 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VERAPAMIL TABLETS 120MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

VERAPAMIL HCL TABLETS 160MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

VERAPAMIL HYDROCHLORIDEINJECTION USP

SOLUTION FORINJECTION

2.5MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

VERAPAMIL TABLETS BP 40MG COATED TABLET 40MG GENERICS (UK) LIMITED UNITED KINGDOM

VERLOST COATED TABLETS 150MG RAFARM GREECE

VERMOX TABLET 500MG JANSSEN PAKISTAN

VERMOX SUSPENSION N/A JANSSEN PAKISTAN

VERMOX TABLET 100MG JANSSEN PAKISTAN

VERMOX SUSPENSION 100MG/5ML JANSSEN PAKISTAN

VERMOX TABLET 500MG JANSSEN PAKISTAN

VERMOX 100MG TABLET 100MG JANSSEN-CILAG N.V. BELGIUM

VERMOX 2% SUSPENSION 20MG/ML JANSSEN-CILAG N.V. BELGIUM

VERMOX 500MG TABLET 500MG JANSSEN-CILAG N.V. BELGIUM

VERORAB VACCINE N/A PASTEUR MERIEUXSERUMS & VACCINESLABORATORIES

FRANCE

VERPIR CREAM 5% W/W KLEVA LTD. GREECE

VERRA-MED SOLUTION N/A PERMAMED AG SWITZERLAND

VERRUGON OINTMENT N/A J PICKLES (HARROGATE)LIMITED T/A J PICKLESAND SONS

UNITED KINGDOM

VESSEL SOLUTION FORINJECTION

600 UNITS ALFA WASSERMANNS.P.A.

ITALY

VESSEL SOFT — GELATINCAPSULE

250 UNITS ALFA WASSERMANNS.P.A.

ITALY

VESSIFLEX GEL N/A ALFA WASSERMANNS.P.A.

ITALY

VEXOL 1% OPHTHALMICSUSPENSION

1% W/V ALCON LABORATORIESINC.

UNITED STATES OFAMERICA

VEXOL 1% EYE DROPS EYE DROPS 1% W/V S.A. ALCON COUVREURN.V

BELGIUM

VIAGRA FILM-COATED TABLETS 25MG PFIZER LIMITED UNITED KINGDOM

VIAGRA FILM-COATED TABLETS 50MG PFIZER LIMITED UNITED KINGDOM

VIAGRA FILM-COATED TABLETS 100MG PFIZER LIMITED UNITED KINGDOM

VIAREX INHALER 0.05MG/DOSE SCHERING-PLOUGHNV/SA

BELGIUM

VIARTRIL-S CAPSULES 250MG ROTTAPHARM S.R.L. ITALY

VIBRAMYCIN CAPSULES 100MG PFIZER LIMITED UNITED KINGDOM

VIBRAMYCIN CAPSULE 50MG PFIZER LIMITED UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 741

Trade Name Dosage Form Dose MA Holder Country

VIBRAMYCIN SYRUP 10MG/G PFIZER SA BELGIUM

VIBROCIL DROPS N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

VIBROCIL GEL N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

VIBROCIL SPRAY N/A NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

VI-CAPS CAPSULE N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

VICEMEX EFFERVESCENT TABLETS 1G CIMEX AG SWITZERLAND

VICKS INHALER INHALATION SOLUTION N/A PROCTER & GAMBLE(HEALTH & BEAUTYCARE) LIMITED

UNITED KINGDOM

VICKS MEDINITE ORAL SOLUTION N/A PROCTER & GAMBLE(HEALTH & BEAUTYCARE) LIMITED

UNITED KINGDOM

VICKS SINEX DECONGESTANT NASAL SPRAY N/A PROCTER & GAMBLE(HEALTH & BEAUTYCARE) LIMITED

UNITED KINGDOM

VICKS VAPORUB NASAL INHALATIONOINTMENT

N/A PROCTER & GAMBLE(HEALTH & BEAUTYCARE) LIMITED

UNITED KINGDOM

VICKS VAPOSYRUP FOR CHESTYCOUGHS

ORAL SOLUTION 1.333%W/V PROCTER & GAMBLE(HEALTH & BEAUTYCARE) LIMITED

UNITED KINGDOM

VICKS VAPOSYRUP FOR TICKLYCOUGHS

ORAL SOLUTION 0.125% W/V PROCTER & GAMBLE(HEALTH & BEAUTYCARE) LIMITED

UNITED KINGDOM

VICKS VAPOUR RUB BALM NA PROCTOR & GAMBLE PAKISTAN

VICOMBIL SYRUP NA BIAL — PRODUTOSFARMACEUTICOS

PORTUGAL

VICOMBIL SYRUP SYRUP NA BIAL — ARISTEGUI,PRODUTOSFARMACEUTICOS, SA

PORTUGAL

VIDENE ANTISEPTIC SOLUTION TOPICAL SOLUTION 10% W/W ADAMS HEALTHCARELIMITED

UNITED KINGDOM

VIDENE ANTISEPTIC TINCTURE TOPICAL SOLUTION 10% W/W ADAMS HEALTHCARELIMITED

UNITED KINGDOM

VIDENE SURGICAL SCRUB CUTANEOUS SPONGE 7.5% W/W ADAMS HEALTHCARELIMITED

UNITED KINGDOM

VIDEO-LIGHT EYE DROPS 0.01G/100ML FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

VIDEO-MILL EYE DROPS 0.1% W/V FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

VIDERMINA OVULES 5MG ISTITUTO GANASSINIS.P.A DI RICERCHEBIOCHIMICHE

ITALY

VIDEX TABLETS 100MG BRISTOL-MYERS SQUIBBEESTI AS

ESTONIA

EL742 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VIDEX CHEWABLE BUFFEREDTABLETS

100MG BRISTOL-MYERS SQUIBBCOMPANY — USA

UNITED STATES OFAMERICA

VIDISEPT EYE DROPS 50MG/ML DR. GERHARD MANN,CHEM.-PHARM. FABRIKGMBH

GERMANY

VIDISIC EYE GEL 2MG/1G DR.GERHARD MANN,CHEM-PHARM. FABRIKGMBH

GERMANY

VIGAM LIQUID SOLUTION FORINJECTION

5% W/V BIOPRODUCTSLABORATORY (BPL)

UNITED KINGDOM

VIGAM-S, INTRAVENOUS HUMANIGG

POWDER FOR INJECTION 5%W/V BPI, BIO PRODUCTSLABORATORY

UNITED KINGDOM

VIGORAN CAPSULE N/A LABORATOIRE GOLAZSA

SWITZERLAND

VIGORAN CAPSULES NA LABORATOIRE GOLAZSA

SWITZERLAND

VILONIT EMUGEL 1% W/W KLEVA LTD GREECE

VINBLASTINE INJECTION SOLUTION FORINJECTION

10MG/10ML F.H. FAULDING & CO.LTD. (T/A DAVID BULLLABS)

UNITED KINGDOM

VINBLASTINE SULPHATE INJ.SOLUTION

SOLUTION FORINJECTION

1MG/1ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

VINCRISTINE SOLUTION FORINJECTION

1MG/ML TEVA PHARMA BV NETHERLANDS

VINCRISTINE PIERRE FABRE INJECTABLE SOLUTION 1MG/1ML PIERRE FABREMEDICAMENT

FRANCE

VINCRISTINE SULFATE SOLUTION FORINJECTION

2MG/2ML F.H. FAULDING & CO.LTD. (T/A DAVID BULLLABS)

AUSTRALIA

VINCRISTINE SULFATE 2MG/2ML SOLUTION FORINJECTION

1MG/ML PHARMACIA & UPJOHN(PERTH) PTY LTD.

AUSTRALIA

VINCRISTINE SULFATE SOL. FORINJECTION

SOLUTION FORINJECTION

N/A ABIC LTD.PHARMACEUTICAL &CHEMICAL INDUSTRIES

ISRAEL

VINCRISTINE SULPHATE F/INJLYOPHILISED

LYOPHILISED CAKE FORINJ

1MG/VIAL M/S SERUM INSTITUTEOF INDIA LIMITED

INDIA

VINCRISTINE SULPHATE FORINJECTION BP

POWDER FOR INJECTION 1MG SERUM INSTITUTE OFINDIA LTD

INDIA

VINCRISTINE SULPHATE FORINJECTION BP

POWDER FOR INJECTION 2MG SERUM INSTITUTE OFINDIA LTD

INDIA

VINCRISTINE SULPHATEINJECTION

SOLUTION FORINJECTION

1MG/ML FAULDINGPHARMACEUTICALS PLC

UNITED KINGDOM

VIOXX 12.5MG TABLETS TABLET 12.5MG MERCK SHARP & DOHMELTD.

UNITED KINGDOM

VIOXX 12.5MG/5ML ORALSUSPENSION

ORAL SUSPENSION 12.5MG/5ML MERCK SHARP & DOHMELTD.

UNITED KINGDOM

VIOXX 25MG TABLETS TABLET 25MG MERCK SHARP & DOHMELTD.

UNITED KINGDOM

VIOXX 25MG/5ML ORALSUSPENSION

ORAL SUSPENSION 25MG/5ML MERCK SHARP & DOHMELTD.

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 743

Trade Name Dosage Form Dose MA Holder Country

VIOXXACUTE TABLETS 50 MG MERCK SHARP ANDDOHME LIMITED

UNITED KINGDOM

VIPROLOX TABLETS 250MG AEGIS LTD CYPRUS

VIRACEPT POWDER FOR ORAL SOL. N/A ROCHE PHARMA(SCHWEIZ) LTD

SWITZERLAND

VIRACEPT TABLET 250MG ROCHE PHARMA(SCHWEIZ) LTD.

SWITZERLAND

VIRAMUNE TABLETS 200MG BOEHRINGER INGELHEIMINTERNATIONAL GMBH

GERMANY

VIRATIN TABLET 40MG RAZA MANUFACTURINGBERHAD

MALAYSIA

VIRGAN GEL 0.15% N/A LABORATOIRES THEA FRANCE

VIRORMONE INJECTION SOLUTION FORINJECTION

100MG/2ML FERRINGPHARMACEUTICALSLIMITED

UNITED KINGDOM

VIROX TABLET 200MG SM PHARMACEUTICALSSDN. BHD.

MALAYSIA

VIRUCID 200 TABLETS 200MG AEGIS LTD. CYPRUS

VIRUCID 400 TABLETS 400MG AEGIS LTD. CYPRUS

VIRUCID 800 TABLETS 800MG AEGIS LTD. CYPRUS

VIRU-MERZ SEROL GEL 0.1/10G MERZ+CO. GMBH & CO. GERMANY

VISCOAT OCULAR VISCOELASTICSOLN.

N/A S.A ALCON-COUVREURN.V.

BELGIUM

VISIPAQUE SOLUTION FORINJECTION

150MG I/ML NYCOMED IMAGING AS NORWAY

VISIPAQUE SOLUTION FORINJECTION

270MG I/ML NYCOMED IMAGING AS NORWAY

VISIPAQUE SOLUTION FORINJECTION

320MG I/ML NYCOMED IMAGING AS NORWAY

VISIPAQUE SOLUTION FORINJECTION

SEE REMARKS AMERSHAM HEALTH AS NORWAY

VISIPAQUE SOLUTION FORINJECTION

SEE REMARKS AMERSHAM HEALTH AS NORWAY

VISKALDIX TABLETS N/A NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VISKALDIX TABLET N/A SANDOZ PAKISTAN

VISKALDIX TABLETS NA NOVARTIS PAKISTAN

VISKALDIX TABLETS NA NOVARTIS PHARMAGMBH

GERMANY

VISTACARPINE EYE DROPS2%W/V

EYE DROPS 2%W/V MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

VISTACARPINE EYE DROPS 4%W/V

EYE DROPS 4%W/V MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

VISTAMETHASONE DROPS EYE DROPS 0.1%W/V MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

EL744 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VISTA-METHASONE N DROPSF/EYE,EAR AND NOSE

EYE DROPS N/A MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

VISTAPHENICOL EYE DROPS 0.5%BP

EYE DROPS 0.5%W/V MARTINDALEPHARMACEUTICALS LTD

UNITED KINGDOM

VISUDYNE POWDER FOR SOLN. FORINJ.

15MG CIBA VISION AG SWITZERLAND

VISUDYNE POWDER F/SOL F/INFUSION

15MG NOVARTISOPHTHALMICS AG

SWITZERLAND

VIT A N OPHTHALMIC OINTMENT 25000 IU/100G FARMIGEA SPA ITALY

VIT B DENK FILM COATED TABLET NA E.DENK OHG GERMANY

VITAMIN 15 SOLCO COATED TABLETS N/A SOLCO BASLE LTD. SWITZERLAND

VITAMIN A EYE OINTMENT 10.0MG/G NOVARTISOPHTHALMICS AG

SWITZERLAND

VITAMIN A 10 000 E/G DISPERSA EYE OINTMENT 10 000IU/G CIBA VISION AG SWITZERLAND

VITAMIN B CO. BPC TABLET N/A SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

VITAMIN B COMPOUND TABLETS N/A REMEDICA LTD CYPRUS

VITAMIN B COMPOUND TABLETS NA PHARMAMED LTD. MALTA

VITAMIN C 100 TABLETS 100MG AEGIS CYPRUS

VITAMIN C 1000MG OBERLIN EFFERVESCENT TABLETS 1000MG LABORATOIRES OBERLIN FRANCE

VITAMIN C 50 TABLETS 50MG AEGIS LTD. CYPRUS

VITAMIN C 500 TABLETS 500MG AEGIS LTD. CYPRUS

VITAMIN C EFFERVESCENT TABLET 1000MG KRUGER GMBH & CO. KG GERMANY

VITAMIN C RED ORANGEEFFERVESCENT

TABLET 1000MG KRUGER GMBH & CO. KG GERMANY

VITAMIN C UPSA EFFERVESCENT1000MG

EFFERVESCENT TABLETS 1000MG LABORATOIRES UPSA FRANCE

VITAMIN D 5000 CAPSULE 5MG SLOVAKOPHARMA ASHLOHOVEC

SLOVAK REPUBLIC

VITAMIN D 800 CAPSULES 0.8MG SLOVAKPHARMA A.S.HLOHOVEC

SLOVAK REPUBLIC

VITAMIN K1 SOLUTION FORINJECTION

2MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

VITAMIN K1 SOLUTION FORINJECTION

10MG/ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

VITAMIN K1 INJECTION(PHYTONADIONE INJ USP)

SOLUTION FORINJECTION

1MG/0.5ML ABBOTT LABORATORIES UNITED STATES OFAMERICA

VITAPLUS C PLUS TABLETS N/A ADCOCK INGRAM LTD SOUTH AFRICA

VITARNIN EFFERVESCENT TABLET N/A DR.GROSSMANN AGPHARMACA

SWITZERLAND

VITATHION EFFERVESCENTGRANULES

N/A LES LABORATOIRESSERVIER

FRANCE

VITIRON SUSCAPS N/A MEPHA PHARMA AG SWITZERLAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 745

Trade Name Dosage Form Dose MA Holder Country

VITLIPID N ADULT EMULSION FORINFUSION

NA FRESENIUS KABI LIMITED UNITED KINGDOM

VITLIPID N ADULT EMULSIONFOR INJECTION

EMULSION FORINFUSION

N/A FRESENIUS KABI LIMITED UNITED KINGDOM

VITLIPID N INFANT EMULSION EMULSION FORINFUSION

NA FRESENIUS KABI LIMITED UNITED KINGDOM

VITREOLENT EYE DROPS N/A CIBA VISION AG SWITZERLAND

VITREOLENT EYE DROPS NA NOVARTISOPHTHALMICS AG

SWITZERLAND

VITRIMIX INTRAVENOUS INFUSION N/A PHARMACIA & UPJOHNSVERIGE AB

SWEDEN

VITRITE/SEVEN SEAS/MINADEXMULTIVIT. SYR

ORAL SOLUTION N/A SEVEN SEAS LIMITED UNITED KINGDOM

VIVALAN COATED TABLETS 50MG ZENECA LIMITED UNITED KINGDOM

VIVIDRIN ANTI-ALLERGICEYEDROPS

SOLUTION 20MG/ML DR. GERHARD MANN,CHEM.-PHARM. FABRIKGMBH

GERMANY

VIVIOPTAL CAPSULES NA DR.GERHARD MANN,CHEM.PHARM. FABRIKGMBH

GERMANY

VIVOTIF BERNA CAPS FOR ORALIMMUNISAT.

N/A SWISS SERUM ANDVACCINE INSTITUTE

SWITZERLAND

VIVOTIF BERNA CAPSULE N/A ISTITUTOSIEROTERAPICO BERNAS.R.L.

ITALY

VOLMAX CONTROLLED RELEASETABLET

4MG GLAXOSMITHKLINEGMBH & CO KG

GERMANY

VOLMAX CONTROLLED RELEASETABLET

4MG GLAXO ALLEN S.P.A. ITALY

VOLMAX 4MG MODIFIED RELEASETABLETS

4MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

VOLMAX 8MG MODIFIED RELEASETABLETS

8MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

VOLMAX TABLETS 4MG MODIFIED RELEASETABLET

4MG GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

VOLMAX TABLETS 8MG MODIFIED RELEASETABLET

8MG GLAXO WELLCOME UKLTD T/A ALLEN &HANBURYS

UNITED KINGDOM

VOLTAMICIN EYE DROPS N/A CIBA VISION AG SWITZERLAND

VOLTAMICIN EYE DROPS NA NOVARTISOPHTHALMICS AG

SWITZERLAND

VOLTAREN EMUGEL 10MG/G NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN ENTERIC COATEDTABLETS

25MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN ENTERIC COATEDTABLETS

50MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

EL746 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VOLTAREN SUPPOSITORIES 12.5MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN SUPPOSITORIES 50MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN SUPPOSITORIES 100MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN TABLET 25MG GEIGY PAKISTAN

VOLTAREN TABLET 50MG GEIGY PAKISTAN

VOLTAREN EMULGEL N/A GEIGY PAKISTAN

VOLTAREN E/C TABLETS 50MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN DISPERSABLE TABLETS 50MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN AMPOULES 75MG NOVARTIS NV —BELGIUM

BELGIUM

VOLTAREN SUPPOSITORY 100MG NOVARTIS PHARMAGMBH

GERMANY

VOLTAREN SUPPOSITORY 50MG NOVARTIS PHARMAGMBH

GERMANY

VOLTAREN FILM COATED TABLETS 25MG NOVARTIS PHARMAGMBH

AUSTRIA

VOLTAREN FILM COATED TABLETS 50MG NOVARTIS PHARMAGMBH

AUSTRIA

VOLTAREN GASTRO-RESISTANTTABLETS

50MG NOVARTIS FARMA SPA ITALY

VOLTAREN DISPERSABLE TABLETS 50MG NOVARTIS (HELLAS)SACL

GREECE

VOLTAREN 1% EMULGEL 1G/100G NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN 1.5% ORAL DROPS (SUSP.) 15MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN DISPERS TABLETS 50MG NOVARTIS PHARMAGMBH

AUSTRIA

VOLTAREN OPHTHA EYE DROPS 1MG/ML NOVARTIS PHARMA(SCHWEIZ) AG

SWITZERLAND

VOLTAREN OPHTHA EYE DROPS 1.00MG/ML NOVARTISOPHTHALMICS AG

SWITZERLAND

VOLTAREN RETARD S.R. FILM COATEDTABLETS

100MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

VOLTAREN RETARD FILM COATED TABLETS 75MG NOVARTIS PHARMASCHWIEZ

UNITED KINGDOM

VOLTAREN RETARD FILM COATED TABLET 100MG NOVARTIS GMBH AUSTRIA

VOLTAREN RETARD FILM COATED TABLETS 75MG NOVARTIS PHARMAGMBH

AUSTRIA

VOLTAREN SR SLOW RELEASE TABLETS 75MG NOVARTIS FARMA SPA ITALY

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 747

Trade Name Dosage Form Dose MA Holder Country

VOLTAROL SUPPOSITORIES SUPPOSITORIES 12.5 MG NOVARTISPHARMACEUTICALS UKLIMITED

IRELAND

VOLTRAL TABLETS 50MG NOVARTIS PAKISTAN

VOLTRAL TABLET 25MG NOVARTIS PAKISTAN

VOLTRAL EMUGEL 1G/100G NOVARTIS PAKISTAN

VOMILUX TABLETS 10MG ATCO LABORATORIES(PVT) LTD

PAKISTAN

VOMILUX SUSPENSION 1MG/1ML ATCO LABORATORIES(PVT) LTD

PAKISTAN

VOSTAR 100 MG SUPPOSITORY SUPPOSITORY 100 MG DELTA HF ICELAND

VOSTAR 25 MGGASTRO-RESISTANT TABLETS

TABLETS 25MG DELTA HF ICELAND

VOSTAR 50 MGGASTRO-RESISTANT TABLETS

TABLET 50 MG DELTA HF ICELAND

VOSTAR 50 MG SUPPOSITORY SUPPOSITORY 50 MG DELTA HF ICELAND

VOSTAR-R 100MG PROLONGEDRELEASE

TABLET 100 MG DELTA HF ICELAND

VOSTAR-R 75 MG PROLONGEDRELEASE

TABLET 75MG DELTA HF ICELAND

V-PLEX TABLET TABLET N/A THE ACME LABRATORIESLTD — BANGLADESH

BANGLADESH

WARFARIN TABLETS 1MG NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

WARFARIN TABLETS 3MG NORTONPHARMACEUTICALSLIMITED

UNITED KINGDOM

WARFARIN TABLETS 5MG NORTON HEALTHCARELIMITED

UNITED KINGDOM

WARFARIN 1MG TABLETS TABLET 1MG FORLEY GENERICS LTD UNITED KINGDOM

WARFARIN 3MG TABLETS TABLETS 3MG FORLEY GENERICS LTD UNITED KINGDOM

WARFARIN 5MG TABLETS TABLETS 5MG FORLEY GENERICSLIMITED

UNITED KINGDOM

WARIACTIV SPRAY 88G/100ML WALTER RITTER GMBH +CO

GERMANY

WARI-FIGURAN-M SUGAR COATED TABLET N/A ARTESAN PHARMAGMBH & CO. KG

GERMANY

WARI-PROCOMIL S/C TABLETS N/A WALTER RITTER GMBH +CO.

GERMANY

WARTEX OINTMENT N/A J PICKLES (HARROGATE)LIMITED

UNITED KINGDOM

WARTICON TOPICAL SOLUTION 0.5%W/W STIEFEL LABORATORIESUK LIMITED

UNITED KINGDOM

WARTICON CREAM CREAM 0.15%W/W STIEFEL LABORATORIESUK LIMITED

UNITED KINGDOM

EL748 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

WARTICON FEM TOPICAL SOLUTION 0.5%W/V STIEFEL LABORATORIES(UK) LIMITED

UNITED KINGDOM

WASP-EZE SPRAY N/A MUNDIPHARMAPHARMACEUTICALS LTD

CYPRUS

WATER FOR INJECTIONAGUETTANT

WATER FOR INJECTION NO ACTIVE INGR. LABORATOIREAGUETTANT

FRANCE

WATER FOR INJECTION PE SOLUTION FORINJECTION

NO ACTIVE INGR. POLPHARMA S.A. POLAND

WATER FOR INJECTION/DEMO SOLUTION FORINJECTION

NO ACTIVE ING. DEMO ABEE GREECE

WATER FOR INJECTION/DEMO SOLUTION FORINJECTION

NO ACTIVE ING. DEMO ABEE GREECE

WATER FOR INJECTIONS SOLVENT FORPARENTERAL US

NA PHARMAMEDPARENTERALS LTD.

MALTA

WATER FOR INJECTIONS BP SOLUTION FORINJECTION

NO ACTIVE ING. B.BRAUN MELSUNGEN GERMANY

WATER FOR INJECTIONS BP SOLUTION FORINJECTION

NO ACTIVE ING. B.BRAUN MELSUNGENAG

GERMANY

WATERLEX TABLETS COATED TABLET N/A CATHAY OFBOURNEMOUTH LTD

UNITED KINGDOM

WAXSOL SOLUTION 0.5%W/V NORGINE LIMITED UNITED KINGDOM

WAXSOL EAR DROPS 0.5% W/V NORGINE LIMITED UNITED KINGDOM

WAXWANE EAR DROPS EAR DROPS N/A THORNTON & ROSS LTD UNITED KINGDOM

WELLBUTRIN SR SUSTAINED RELEASETABLET

150MG GLAXO WELLCOME INC. CANADA

WELLFERON INTERFERONALFA-NI (1NS) 10MU

SOLUTION FORINJECTION

10MU/ML THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

WELLFERON INTERFERONALFA-NI (1NS) 3MU

SOLUTION FORINJECTION

3MU/1ML THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

WHITE SOFT PARAFFIN BP OINTMENT NA BELL SONS &CO(DRUGGISTS) LIMITED

UNITED KINGDOM

WHITFIELD'S OINTMENT OINTMENT N/A BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

WILPRAFEN SUSPENSION 3G/100ML YAMANOUCHI PHARMAGMBH

GERMANY

WILPRAFEN FILM-COATED TABLETS 500MG YAMANOUCHI PHARMAGMBH

GERMANY

WILPRAFEN FORTE SUSPENSION 6G/100ML YAMANOUCHI PHARMAGMBH

GERMANY

WINRHO SDF — KIT PWS(1500IU)

POWDER FOR INJECTION N/A CANGENECORPORATION

CANADA

WINRHO SDF-KIT PWS 1500IU POWDER FOR REC. 1500IU/2.5ML CANGENECORPORATION

CANADA

WINRHO SDF-KIT PWS(600IU) POWDER FOR REC. 600IU/2.5ML CANGENECORPORATION

CANADA

WITCH DOCTOR GEL GEL 81.539%W/W E C DE WITT & CO LTD UNITED KINGDOM

WITCH DOCTOR STIK SOLID STICK 15.88%W/W E C DE WITT & CO LTD UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 749

Trade Name Dosage Form Dose MA Holder Country

WITCH HAZEL DISTILLED BPC1973

TOPICAL SOLUTION 100%V/V LCM LTD UNITED KINGDOM

WOBE-MUGOS E ENTERIC COATEDTABLET

N/A MUCOS PHARMA GMBH& CO.

GERMANY

WOBENZYM N SUG. COAT. GAST-RES.TABL

N/A MUCOS PHARMA GMBH& CO.

GERMANY

WOODWARD'S GRIPE WATER —ALC. AND SUGAR FR

ORAL SOLUTION N/A SETON PRODUCTS LTD. UNITED KINGDOM

WOODWARD'S GRIPE WATER —ALCOHOL FREE

ORAL SOLUTION N/A SETON PRODUCTS LTD. UNITED KINGDOM

XALACOM EYE DROPS NA PHARMACIA NV/SA BELGIUM

XALATAN EYE DROPS 50MCG/ML PHARMACIA & UPJOHNAB

BELGIUM

XALATAN EYE DROPS 0.005% W/V PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

XANAX TABLETS 0.25MG PHARMACIA N.V./S.A. BELGIUM

XANAX TABLETS 0.5MG PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

XANAX TABLETS 1MG PHARMACIA & UPJOHNN.V. / S.A.

BELGIUM

XANOMEL 150 FILM-COATED TABLETS 150MG CLONMEL HEALTHCARELIMITED

IRELAND

XATRAL LP 10MG PROLONGED RELEASETABLET

10MG LABORATOIRESSYNTHELABO

FRANCE

XATRAL SR 5MG SR FILM-COATED TABLET 5MG LABORATOIRESSYNTHELABO

FRANCE

XELODA 150MG FILM COATED TABLETS 150MG ROCHE PHARMASCHWEIZ LTD.

SWITZERLAND

XELODA 500MG FILM COATED TABLETS 500MG ROCHE PHARMASCHWEIZ LTD.

SWITZERLAND

XENAR TABLETS 250MG ALFA WASSERMANNS.P.A.

ITALY

XENAR CONTROLLED RELEASETABLET

750MG ALFA WASSERMANNS.P.A.

ITALY

XENICAL CAPSULES 120MG ROCHE PHARMA(SCHWEIZ) AG

SWITZERLAND

XEPIN CREAM 5% W / W BIOGLANLABORATORIES LTD

UNITED KINGDOM

XIGRIS POWDER FOR SOLUTIONFOR INFUSION

2MG/ML ELI LILLY NEDERLANDBV

EUROPEAN COMMUNITY

XITHRONE CAPSULES 250MG AMOUNPHARMACEUTICALS COSAE

EGYPT

XYLOCAIN SOLUTION FORINJECTION

10MG/ML ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN SOLUTION FORINJECTION

20MG/ML ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN SPRAY SOLUTION 10MG/DOSE ASTRA LAKEMEDEL AB SWEDEN

EL750 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

XYLOCAIN GEL 2% W/W ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN OINTMENT 5% W/W ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN SOLUTION FORINJECTION

10MG/ML ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN SOLUTION FORINJECTION

20MG/ML ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN ADRENALIN SOLUTION FORINJECTIONS

N/A ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN ADRENALIN SOLUTION FORINJECTION

N/A ASTRA LAKEMEDEL SWEDEN

XYLOCAIN ADRENALIN SOLUTION FORINJECTION

N/A ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN ADRENALIN SOLUTION FORINJECTION

20MG ASTRAZENECA SVERIGEAB

SWEDEN

XYLOCARD SOLUTION FORINJECTION

20MG/ML HASSLE LAKEMEDEL AB SWEDEN

XYLOCARD CONCENTRATE FORINFUSION

200MG/ML HASSLE LAKEMEDEL AB SWEDEN

XYLONOR SOLUTION FOR DENTALUSE

N/A LABORATOIRESSEPTODONT

FRANCE

XYLONOR GINGIVAL GEL N/A LABORATOIRESSEPTODONT

FRANCE

XYLOPROCT OINTMENT N/A TIKA LAKEMEDEL AB SWEDEN

XYLOPROCT SUPPOSITORIES N/A TIKA LAKEMEDEL AB SWEDEN

XYZAL FILM-COATED TABLETS 5MG UCB-PHARMA AG SWITZERLAND

YASMIN FILM-COATED TABLETS N/A SCHERING AG GERMANY

YEAST 300MG BPC TABLET 300MG SUSSEXPHARMACEUTICALLIMITED

UNITED KINGDOM

YESAN EYE DROPS SOLUTION 0.5% W/V RAFARM GREECE

YUTOPAR TABLET 10MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

YUTOPAR INJECTION FLUID 10MG/ML SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

YUTOPAR SR CAPSULE 40MG SOLVAYPHARMACEUTICALS B.V.

NETHERLANDS

ZACIN CREAM 0.025% CREAM 0.025% W/W BIOGLANLABORATORIES LTD

UNITED KINGDOM

ZACLOFEN TABLET 10MG ALFARESPHARMACEUTICALS

SYRIA

ZACLOFEN TABLETS TABLETS 10 MG ALFARESPHARMACEUTICALS

SYRIA

ZACTIN CAPSULE 20MG ALPHAPHARM PTYLIMITED

AUSTRALIA

ZACTOLINE TABLETS 5MG BIOGLANLABORATORIES LTD

IRELAND

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 751

Trade Name Dosage Form Dose MA Holder Country

ZACTOLINE TABLETS 10MG BIOGLANLABORATORIES LTD

IRELAND

ZADAXIN SOLUTION FORINJECTIONS

1.6MG/ML SCICLONEPHARMACEUTICALSITALY S.R.L.

ITALY

ZADITEN EYE DROPS 0.25MG/ML CIBA VISION AG SWITZERLAND

ZADITEN ORAL SOLUTION 1MG/ML NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ZADITEN TABLETS 1MG NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ZADITEN HARD CAPSULES 1MG NOVARTIS FARMA —PRODUTOSFARMACEUTICOS S.A.

PORTUGAL

ZADITEN 0.025% OPHTHA EYE DROPS NA NOVARTISOPHTHALMICS AG

SWITZERLAND

ZADITEN TABLETS 1MG TABLETS 1MG NOVARTIS PHARM. UK.LTD. T/A SANDOZPHARM.

UNITED KINGDOM

ZADORIN SUSCAPS 100MG MEPHA PHARMA AG SWITZERLAND

ZAMADOL CAPSULES 50MG ASTA MEDICA LTD UNITED KINGDOM

ZAMADOL INJECTION SOLUTION FORINJECTION

50MG/ML ASTA MEDICA LTD UNITED KINGDOM

ZAMADOL SR CAPSULES 100MG MODIFIED RELEASECAPSULE

100MG ASTA MEDICA LTD UNITED KINGDOM

ZAMADOL SR CAPSULES 150MG MDIFIED RELEASECAPSULE

150MG ASTA MEDICA LTD UNITED KINGDOM

ZAMADOL SR CAPSULES 200MG MODIFIED RELEASECAPSULE

200MG ASTA MEDICA LTD. UNITED KINGDOM

ZAMADOL SR CAPSULES 50MG MODIFIED RELEASECAPSULE

50MG ASTA MEDICA LIMITED UNITED KINGDOM

ZANTAC TABLET 150MG GLAXO WELLCOME PAKISTAN

ZANTAC FILM-COATED TABLETS 75 MG DUNCANFARMACEUTICA S. A

SPAIN

ZANTAC EFFERVESCENT TABLETS 150MG LABORATOIRESGLAXOSMITHKLINE

FRANCE

ZANTAC EFFERVESCENT TABLETS 300MG LABORATOIRESGLAXOSMITHKLINE

FRANCE

ZANTAC TABLETS 300MG GLAXO LABORATORIESLIMITED

UNITED KINGDOM

ZANTAC TABLETS 150MG GLAXO LABORATORIESLIMITED

UNITED KINGDOM

ZANTAC SYRUP NA GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZANTAC 150 FILM-COATEDTABLET

TABLET 150MG GLAXO WELLCOME S.A. SPAIN

ZANTAC 300MG COATED TABLETS 300MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

EL752 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ZANTAC 75 RELIEF TABLETS 75MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZANTAC 75MG TABLETS 75MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZANTAC EFFERVESCENT TABLETS EFFERVESCENT TABLETS 150MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZANTAC INJECTION SOLUTION FORINJECTION

50MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZANTAC INJECTION SOLUTION FORINJECTION

50MG/2ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZANTAC INJECTION (50MG/2ML) SOLUTION FORINJECTION

50MG/2ML GLAXO WELLCOME UKLTD T/A GLAXO LABS

UNITED KINGDOM

ZANTAC SYRUP ORAL SOLUTION 150MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZANTAC SYRUP ORAL SOLUTION 150MG/10ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZANTAC SYRUP ORAL SOLUTION 150MG/DOSE GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZANTAC TABLETS TABLET 150MG GLAXO WELLCOME PAKISTAN

ZANTAC TABLETS COATED TABLETS 150MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZANTAC TABLETS 150MG COATED TABLET 150MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZANTAC TABLETS 300MG COATED TABLET 300MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZANTAC TABLETS 75MG TABLET 75MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZARONTIN CAPSULES 250MG CAPSULE 250MG WARNER LAMBERT (UK)LIMITED

UNITED KINGDOM

ZAVEDOS POWDER FOR INJECTION 5MG/VIAL PHARMACIA & UPJOHNS.P.A.

ITALY

ZAVEDOS POWDER FOR INJECTION 10MG/VIAL PHARMACIA & UPJOHNS.P.A

ITALY

ZAVEDOS CAPSULES 5MG PHARMACIA & UPJOHNS.P.A.

ITALY

ZAVEDOS CAPSULES 10MG PHARMACIA & UPJOHNS.P.A.

ITALY

ZAVEDOS CAPSULE 25MG PHARMACIA & UPJOHNS.P.A.

ITALY

ZAVERA TABLET 240MG ZAFA PAKISTAN

ZELMAC TABLETS 6MG NOVARTIS PHARMASCHWEIZ AB

SWITZERLAND

ZELOXIM TABLET 7.5MG BILIM ILAC SANAYIIA VEATICARET AS

TURKEY

ZELOXIM 15MG FORT TABLET 15MG BILIM ILAC SANANYII VETICARET AS

TURKEY

ZENALB (TM) 4.5 HUMANALBUMIN 4.5%

SOLUTION FORINJECTION

4.5% W/V BPL, BIO PRODUCTSLABORATORY

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 753

Trade Name Dosage Form Dose MA Holder Country

ZENALB-20, 20% HUMANALBUMIN SOLUTION

STERILE LIQ. FORINFUSION

N/A BPL, BIO PRODUCTSLABORATORY

UNITED KINGDOM

ZENTEL 0.4G/10ML ORAL SUSPENSION 0.4G/10ML LABORATOIRESSMITHKLINE BEECHAM

FRANCE

ZENTEL 400MG FILM-COATED TABLET 400MG LABORATOIRESSMITHKLINE BEECHAM

FRANCE

ZEPHOLIN TABLETS 10MG GENEPHARM S.A. GREECE

ZERIT CAPSULES 30MG BRISTOL-MYERS SQUIBBCOMPANY

UNITED STATES OFAMERICA

ZERIT CAPSULES 40MG BRISTOL-MYERS SQUIBBPHARMA EEIG

EUROPEAN COMMUNITY

ZESTORETIC 20 TABLET N/A ZENECA LIMITED UNITED KINGDOM

ZESTORETIC-20 TABLETS N/A ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLET 5MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLET 10MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLETS 20MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL 5MG TABLETS 5MG ICI PAKISTAN

ZESTRIL TABLETS 10MG TABLET 10MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLETS 20MG TABLET 20MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLETS 5MG TABLET 5MG ZENECA LIMITED UNITED KINGDOM

ZETAGAL POWDER FOR INJECTION 750MG/VIAL ELPEN S.A. GREECE

ZETAGAL POWDER FOR INJECTION 250MG/VIAL ELPEN S.A GREECE

ZETALAX SUPPOSITORIES 2.25G ZETA FARMACEUTICIS.P.A.

ITALY

ZETRIZIN FILM COATED TABLET 10MG ALFARESPHARMACEUTICALS

SYRIA

ZETRIZIN SYRUP 5MG/5ML ALFARESPHARMACEUTICALS

SYRIA

ZETRIZIN FILM — COATEDTABLETS

FILM-COATED TABLETS 10 MG ALFARESPHARMACEUTICALS

SYRIA

ZETRIZIN SYRUP SYRUP 5MG ALFARESPHARMACEUTICALS

SYRIA

ZIAGEN FILM COATED TABLETS 300MG GLAXO GROUP LTD. UNITED KINGDOM

ZIAGEN ORAL SOLUTION 20MG/ML GLAXO GROUP LTD. UNITED KINGDOM

ZIDEPRIL TABLETS 50MG/25MG MINERVAPHARMACEUTICAL S.A.

GREECE

ZIDOVAL VAGINAL GEL 0.75% W/W 3M HEALTH CARELIMITED

UNITED KINGDOM

ZIDOVIR 100 CAPSULES 100MG CIPLA LTD INDIA

ZIDOVUDINE COMBINO PHARM CAPSULES 100MG COMBINO PHARM SL SPAIN

EL754 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ZILISTEN DRY POWDER F/INJECTION

750MG/VIAL DEMO ABEE GREECE

ZILISTEN VIAL DRY POWDER 1500 MG DEMO S.A. GREECE

ZIMOR CAPSULES 20MG LABORATORIOS RUBIOS.A

SPAIN

ZINACEF POWDER FOR INJECTION 750MG GLAXO OPERATIONS UKLIMITED

UNITED KINGDOM

ZINACEF POWDER FOR INJECTION 250MG GLAXO OPERATIONS UKLIMITED

UNITED KINGDOM

ZINACEF «250» IM FLAC 250MG +1FIALA 1ML

POWDER AND SOL FORINJ.

N/A GLAXOSMITHKLINE S.P.A ITALY

ZINACEF «750» IM FLAC 750MG +F3ML

POWDER AND SOL FORINJ.

N/A GLAXOSMITHKLINE S.P.A ITALY

ZINACEF INJECTION 1.5G POWDER FOR INJECTION 1.5G GLAXO OPERATIONS UKLTD

UNITED KINGDOM

ZINACEF INJECTION 250MG POWDER FOR INJECTION 250MG GLAXO OPERATIONS UKLTD

UNITED KINGDOM

ZINACEF INJECTION 750MG POWDER FOR INJECTION 750MG GLAXO OPERATIONS UKLTD

UNITED KINGDOM

ZINC AND CASTOR OILOINTMENT BP

OINTMENT 7.5% W/W ADAMS HEALTHCARELIMITED

UNITED KINGDOM

ZINC AND CASTOR OILOINTMENT BP

OINTMENT N/A LCM LTD UNITED KINGDOM

ZINCABAND PASTE BANDAGE PAD 15% W/W SETON HEALTHCAREGROUP PLC

UNITED KINGDOM

ZINCAST OINTMENT N/A BELL, SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

ZINCAST BABY CREAM OINTMENT N/A BELL SONS & CO(DRUGGISTS) LIMITED

UNITED KINGDOM

ZINCOMETIL EYE DROPS N/A FARMILA FARMACEUTICIMILANO S.P.A.

ITALY

ZINDOLIN TABLETS 250MG REMEDICA LTD CYPRUS

ZINELI EYE DROPS SOLUTION 2% W/V RAFARM GREECE

ZINERYT LOTION N/A YAMANOUCHI PHARMAB.V.

NETHERLANDS

ZINNAT SUSPENSION N/A GLAXO WELLCOME PAKISTAN

ZINNAT TABLET 250MG GLAXO WELLCOME PAKISTAN

ZINNAT COATED TABLETS 500MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZINNAT TABLETS 500MG GLAXO LABORATORIESLIMITED

UNITED KINGDOM

ZINNAT ORAL SUSPENSION 250MG/5ML GLAXO LABORATORIESLIMITED

UNITED KINGDOM

ZINNAT SUSPENSION GRANULES F/ORAL SUSP. 250MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 755

Trade Name Dosage Form Dose MA Holder Country

ZINNAT SUSPENSION GRANULES F/ORAL SOLN 125MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZINNAT SUSPENSION GRANULES FOR ORALSOLN

125MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZINNAT SUSPENSION 125MG/5ML GRANULES FOR ORALSOLN.

125MG/5ML GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZINNAT SUSPENSION 250MG/5ML GRANULES FOR ORALSUSP.

250MG/5ML GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZINNAT TABLETS TABLETS 250MG GLAXOWELLCOME PAKISTAN

ZINNAT TABLETS COATED TABLETS 125MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZINNAT TABLETS COATED TABLETS 250MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZINNAT TABLETS 125MG COATED TABLET 125MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZINNAT TABLETS 250MG COATED TABLET 250MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZITAZONIUM 10MG TABLETS 10MG EGIS PHARMACEUTICALSLTD.

HUNGARY

ZITAZONIUM 20MG TABLETS 20MG EGIS PHARMACEUTICALSLTD.

HUNGARY

ZITHROMAX CAPSULE 250MG PFIZER LIMITED UNITED KINGDOM

ZITHROMAX POWDER FOR ORALSUSPENSIO

N/A PFIZER LIMITED UNITED KINGDOM

ZITHROMAX TABLETS 500MG COATED TABLETS 500MG PFIZER LIMITED UNITED KINGDOM

ZIVIR CAPSULE 100MG OKASA PHARMA PVTLTD- INDIA

INDIA

ZOCOR TABLET 10MG M.S.D. PAKISTAN

ZOCOR TABLETS 40MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

ZOCOR 10MG TABLET 10MG MERCK SHARP & DOHMEB.V.

NETHERLANDS

ZOCOR 10MG TABLETS 10MG MERCH SHARP & DOHME PAKISTAN

ZOCOR 20MG TABLET 20MG MERCK SHARP & DOHME NETHERLANDS

ZOCOR 20MG TABLETS 20MG MERCH SHARP & DOHME PAKISTAN

ZOFRAN INJECTION SOLUTION FORINJECTION

2MG/ML GLAXO OPERATIONS UKLIMITED

UNITED KINGDOM

ZOFRAN INJECTION 2MG/ML SOLUTION FORINJECTION

2MG/ML GLAXO OPERATIONS UKLTD

UNITED KINGDOM

ZOFRAN SYRUP SYRUP 0.1% W/V GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZOFRAN SYRUP ORAL LIQUID 4MG/5ML GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZOFRAN SYRUP ORAL LIQUID 4MG/5ML GLAXO WELLCOME UKLTD

UNITED KINGDOM

EL756 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ZOFRAN SYRUP ORAL LIQUID 4 MG/5ML GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZOFRAN SYRUP ORAL LIQUID 4MG/5ML GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZOFRAN TABLETS COATED TABLET 8MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZOFRAN TABLETS COATED TABLETS 4MG GLAXO WELLCOME UKLIMITED

UNITED KINGDOM

ZOFRAN TABLETS 4MG COATED TABLET 4MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZOFRAN TABLETS 8MG COATED TABLET 8MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZOIRAL TABLETS 10MG AEGIS LTD CYPRUS

ZOIRAL TABLETS 25MG AEGIS LTD CYPRUS

ZOIRAL 10 CAPSULES 10MG AEGIS LTD. CYPRUS

ZOIRAL 25 CAPSULES 25MG AEGIS LTD CYPRUS

ZOIRAL 50 CAPSULES 50MG AEGIS LTD. CYPRUS

ZOLADEX SOLUTION FORINJECTION

3.6MG ZENECA LIMITED UNITED KINGDOM

ZOLADEX LA SUSTAINED RELEASEDEPOT

10.8MG ZENECA LIMITED UNITED KINGDOM

ZOLADEX LA SOLUTION FORINJECTION

10.8MG ZENECA LIMITED UNITED KINGDOM

ZOLAREM 0.25 TABLETS 0.25MG AEGIS LTD. CYPRUS

ZOLAREM 0.5 TABLETS 0.5MG AEGIS LTD. CYPRUS

ZOLAREM 1 TABLET 1MG AEGIS LTD. CYPRUS

ZOMETA POWDER F/SOLUTION F/INF.

4MG/VIAL NOVARTIS PHARMASCHWEIZ AG

SWITZERLAND

ZOMETA POWDER AND SOLVENTF/INF

4MG/VIAL NOVARTIS EUROPHARMLIMITED

EUROPEAN COMMUNITY

ZOMIG COATED TABLETS 2.5MG ZENECA LIMITED UNITED KINGDOM

ZOTON CAPSULES 15MG CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

ZOTON CAPSULES 30MG CYANAMID OF GREATBRITAIN LTD.

UNITED KINGDOM

ZOVIRAX CREAM 0.05G/G GLAXO WELLCOME PAKISTAN

ZOVIRAX SUSPENSION 200MG/5ML GLAXO WELLCOMEGMBH & CO

GERMANY

ZOVIRAX TABLETS 200MG GLAXOSMITHKLINE AB SWEDEN

ZOVIRAX TABLETS 400MG GLAXOSMITHKLINE AB SWEDEN

ZOVIRAX TABLETS 800MG GLAXOSMITHKLINE AB SWEDEN

ZOVIRAX COLD SORE CREAM CREAM 5% W/W THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 757

Trade Name Dosage Form Dose MA Holder Country

ZOVIRAX CREAM CREAM 0.5%W/W GLAXOWELLCOME PAKISTAN

ZOVIRAX EYE OINTMENT 3%W/W

EYE OINTMENT 3% W/W THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

ZOVIRAX I.V. 250MG POWDER FOR INJECTION 250MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

ZOVIRAX SUSPENSION200MG/5ML

ORAL SUSPENSION 200MG/5ML THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

ZOVIRAX TABLETS 200MG TABLETS 200MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

ZOVIRAX TABLETS 400MG TABLETS 400MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

ZOVIRAX TABLETS 800MG TABLETS 800MG THE WELLCOMEFOUNDATION LIMITED

UNITED KINGDOM

ZYBAN SUSTAINED RELEASETABLETS

150MG GLAXO WELLCOME INC. CANADA

ZYBAN PROLONGED RELEASETABLETS

150MG GLAXO WELLCOME UKLTD

UNITED KINGDOM

ZYLORIC TABLETS 100MG THE WELLCOMEFOUNDATION LTD.

UNITED KINGDOM

ZYLORIC TABLETS 300MG THE WELLCOMEFOUNDATION

UNITED KINGDOM

ZYLORIC TABLET 100MG GLAXO WELLCOME PAKISTAN

ZYLORIC TABLET 100MG GLAXO WELLCOME PAKISTAN

ZYLORIC TABLETS 100MG GLAXO WELLCOME SPA ITALY

ZYLORIC SCORED TABLETS 300MG GLAXO WELLCOME SPA ITALY

ZYMAFLUOR TABLETS 0.25MG NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

ZYMAFLUOR TABLETS 1MG NOVARTIS CONSUMERHEALTH SA

SWITZERLAND

ZYMOPLEX TABLET 10MG GENEPHARM S.A. GREECE

ZYOMET GEL 0.75%W/W GOLDSHIELDPHARMACEUTICALSLIMITED

UNITED KINGDOM

ZYPREXA COATED TABLETS 15MG ELI LILLY NEDERLANDBV

EUROPEAN COMMUNITY

ZYPREXA 10MG COATED TABLET 10MG ELI LILLY NEDERLANDBV

NETHERLANDS

ZYPREXA 10MG TABLETS 10MG LILLY PAKISTAN

ZYPREXA 5MG COATED TABLET 5MG ELI LILLY NEDERLANDBV

NETHERLANDS

ZYPREXA 7.5MG COATED TABLET 7.5MG ELI LILLY NEDERLANDBV

NETHERLANDS

ZYRTEC TABLET 10MG UCB PHARMA S.A. FRANCE

EL758 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ZYRTEC ORAL SOLUTION 2.5MG/2.5ML UCB PHARMA S.A. FRANCE

ZYRTEC TABLET 10MG UNITED CHEMICALS OFBELGIUM

PAKISTAN

ZYRTEC TABLET 10MG UCB PAKISTAN

ZYRTEC ORAL SOLUTION 5MG/5ML UCB PAKISTAN

ZYRTEC ORAL SOLUTION 2.5MG/2.5ML UCB PHARMA FRANCE

ZYRTEC FILM COATED TABLETS 10MG UCB PHARMA FRANCE

ZYRTEC SYRUP SYRUP 1MG/1ML UNITED CHEMICALS OFBELGIUM

PAKISTAN

ZYTRAM XL TABLETS 300MG MODIFIED RELEASETABLET

300MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

ZYTRAM XL TABLETS 400MG COATED TABLET 400MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

ZYTRAM-XL TABLETS 150MG MODIFIED RELEASETABLET

150MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

ZYTRAM-XL TABLETS 200MG MODIFIED RELEASETABLETS

200MG NAPP LABORATORIESLIMITED

UNITED KINGDOM

ZYVOX ORAL SUSPENSION NA PHARMACIA & UPJOHNCOMPANY

UNITED STATES OFAMERICA

ZYVOX TABLETS 400MG PHARMACIA & UPJOHNCOMPANY

UNITED STATES OFAMERICA

ZYVOX SOLUTION FORINFUSION

2MG/ML PHARMACIA NORGE AS NORWAY

ZYVOX FILM COATED TABLETS 600MG PHARMACIA LIMITED UNITED KINGDOM

ZYVOX SOLUTION FORINFUSION

2MG/ML PHARMACIA NORGE AS NORWAY

ZYVOXID FILM-COATED TABLETS 600MG PHARMACIA NV/SA BELGIUM

DAIVOBET OINTMENT NA LEO PHARMACEUTICALPRODUCTS

DENMARK

ACTOPHLEM COUGH SYRUP SYRUP NA ADCOCK INGRAM PARK SOUTH AFRICA

INGRAMS CAMPHOR CREAM CREAM 0.67G/100G ADCOCK INGRAMLIMITED

SOUTH AFRICA

LOCAINE A SOLUTION FORINJECTION

NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

REMICAINE JELLY TOPICAL JELLY 2G/100G ADCOCK INGRAMLIMITED

SOUTH AFRICA

COMPRAL HEADACHE TABLETS TABLETS NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

TEEJEL GEL NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

SOLPHYLLEX SYRUP SYRUP NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

GRIPPON CAPSULES CAPSULE NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 759

Trade Name Dosage Form Dose MA Holder Country

ADCO-ACYCLOVIR 200MG TABLETS 200MG ADCOCK INGRAMLIMITED

SOUTH AFRICA

BIOPLUS S SYRUP NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

MYPRODOL SUSPENSION SUSPENSION NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

URIZONE 3 G GRANULES 3G/SACHET ADCOCK INGRAMLIMITED

SOUTH AFRICA

MEDI-KEEL A HONEY ANDLEMON THROAT LOZENGES

LOZENGES NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

MEDI-KEEL A BLACKCURRANTTHROAT LOZENGES

LOZENGES NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

NAZENE NASAL SPRAY NASAL SPRAY NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

BIDOMAK FE LIQUID NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

SABAX FOSENEMA SOLUTION NA ADCOCK INGRAMCRITICAL CARE (PTY)LTD

SOUTH AFRICA

LOTEM SUSPENSION SUSPENSION NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

ADCO-ACYCLOVIR TOPICALCREAM

CREAM 250MG/5G ADCOCK INGRAMLIMITED

SOUTH AFRICA

ADCO-SODASOL GRANULES NA ADCOCK INGRAMLIMITED

SOUTH AFRICA

UNICROM 2% EYE DROPSBTL/5ML

EYE DROPS 2% W/V UNIMED LABORATORY TUNISIA

CALCIUM CHLORIDE10%-UNIMED

SOLUTION FORINJECTION

10% W/V UNIMED LABORATORY TUNISIA

MYDRICOL 0.5% EYE DROPSBTL/5ML

EYE DROPS 0.5% W/V UNIMED LABORATORY TUNISIA

TUSSCODIN RETARD —HUSTENSAFT

SYRUP 0.3G/100ML LANNACHER HEILMITTELGmbH

AUSTRIA

LEUKERAN 2MG TABLETS 2.1MG GLAXO WELLCOMEGmbH & Co

GERMANY

ALLERGOTIN-EYE DROPS SOLUTION 2%W/V COOPER SA GREECE

CIPRALEX FILM-COATED TABLETS20MG

TABLETS 20MG H. LUNDBECK A/S DENMARK

CIPRALEX FILM-COATED TABLETS15MG

TABLETS 15MG H. LUNDBECK A/S DENMARK

CIPRALEX FILM-COATED TABLETS10MG

TABLETS 10MG H. LUNDBECK A/S DENMARK

CIPRALEX FILM-COATED TABLETS5MG

TABLETS 5MG H. LUNDBECK A/S DENMARK

URO VAXOM CAPSULES 6MG OM PHARMA SWITZERLAND

EL760 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HAEMOKION INJECTION SOLUTION FORINJECTION

10MG/ML AMOUNPHARMACEUTICALS CO.S.A.E.

EGYPT

LYSOVIR 100MG CAPSULES CAPSULES 100MG ALLIANCEPHARMACEUTICALSLIMITED

UNITED KINGDOM

AQUEOUS CREAM BP CREAM CREAM 30% W/W JM LOVERIDGE PLC UNITED KINGDOM

TUSCALMAN SYRUP NA LABORATORIOFARMACEUTICO S.I.T.

AUSTRIA

EL23.9.2003 Επίσηµη Εφηµερίδα της Ευρωπαϊκής Ένωσης 761