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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