Teva Pharmaceutical 06.06.2013 06.06.2018 Tancsics Mihaly ... · Teva Pharmaceutical Works Private Limited Company, H-2100 Godollo, Tancsics Mihaly ut 82 Hungary A04AA01 12554 06.06.2013

3166 Ondansetron-Teva

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for injection2mg/ml,

4ml ampoules (5)

Teva Pharmaceutical

Works Private

Limited Company, H-

2100 Godollo,

Tancsics Mihaly ut 82

Hungary A04AA01 1255406.06.2013

06.06.2018PoM

Teva Pharmaceutical

Industries Ltd., 5

Basel str., P.O. Box

3190, Petach Tikva,

49131, Israel


ondansetron

(ondansetron

hydrochloride

dihydrate)


2ml ampoules (5)

Pliva Hrvatska d.o.o.,

Prilaz baruna

Filipovica 25, Zagreb

10000

Croatia A04AA01 1255506.06.2013

06.06.2018PoM

Teva Pharmaceutical

Industries Ltd, 5 Basel

str., P.O. Box 3190,

Petah Tikva, 49131,

Israel


ondansetron

(ondansetron

hydrochloride

dihydrate)


4ml ampoules (5)


Prilaz baruna

Filipovica 25, Zagreb

10000

Croatia A04AA01 1255606.06.2013

06.06.2018PoM

Teva Pharmaceutical

Industries Ltd, 5 Basel

str., P.O. Box 3190,

Petah Tikva, 49131,

Israel

3169 Oramorphmorphine

(morphine sulfate)solution oral

2mg/ml,

100ml glass bottle and

measuring cup

L.Molteni & C. Dei

F.lli Alitti Societa di

Esercizio S.p.A, S. S.

67, Localita

Granatieri, Scandicci,

50018

Italy N02AA01 1657903.04.2017

03.04.2022PoM/UC

L.Molteni & C. Dei



67, Localita


50018, Italy

3170 Oramorph morphine

(morphine sulfate) solution oral

20mg/ml,

20ml glass vial with

dropper

L.Molteni & C. Dei



67, Localita


50018

Italy N02AA01 1691108.08.2017

08.08.2022PoM/UC

L.Molteni & C. Dei



67, Localita


50018, Italy

681

3171 Orasept phenol spray14mg/ml,

177ml plastic bottle

Famar S.A.,National

Road Athens-Lamia,

Km 49, 19011 Avlona

Greece R02AA19 1673505.06.2017

05.06.2022OTC

Bayer Consumer

Care AG, Peter

Merian-Strasse 84,

4052 Basel,

Switzerland

3172 Orgalutranganirelix (ganirelix

acetate)

solution for s/c

injection

0,25mg/0,5ml, 0,5ml pre-

filled syringes (5)

Organon (Ireland)

Ltd., Drynam Road,

Swords, Co. Dublin -

secondary packager,

batch releaser (bulk

manufacturer,

primary packager -

Vetter Pharma-

Fertigung GmbH &

Co. KG,

Schutzenstrasse 87

and 99/101, D-88212

Ravensburg,

Germany)

Ireland H01CC01 12711/129.07.2014

23.07.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

3173 Orgalutranganirelix (ganirelix

acetate)

solution for s/c

injection

0.25mg/0.5ml (0.5mg/ml),

0,5ml pre-filled syringes

(5)

N.V. Organon,

Molenstraat 110, 5342

CC OSS-secondary

packager, batch

releaser (legal address -

N.V. Organon,

Kloosterstraat 6, 5349

AB Oss, the

Netherlands), Vetter

Pharma-Fertigung

GmbH & Co. KG,

Schutzenstrasse 87

and 99/101, D-88212

Ravensburg, Germany-

bulk manufacturer,

primary packager

the Netherlands H01CC01 1445804.05.2015

04.05.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

682

3174 Orlip orlistat capsules120mg,

in blister (30/3x10/)

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi

Georgia A08AB01 1673805.06.2017

05.06.2022PoM

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi, Georgia

3175 Orlobinamikacin (amikacin

sulfate)

solution for

injection/infusion

250mg/ml,

glass vial (1)

Help S.A., Pedini

Ioanninon, Ioannina,

45500

Greece J01GB06 1711323.10.2017

23.10.2022PoM

Medicus S.A., 10

Valaoritou str., GR

144 52,

Metamorphosis,

Attika, Greece

3176 Ornidazole ornidazole tablets film-coated500mg,


Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus P01AB03 1551819.04.2016

19.04.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

3177 Ornimed ornidazole tablets film-coated

500mg,

in blister (10/1x10/,

20/2x10/)

"Rubicon" LLC, 62B,

M. Gorky street,

210002, Vitebsk

Belarus P01AB03 1642210.02.2017

10.02.2022PoM

"Rubicon" LLC, 62B,

M. Gorky street,

210002, Vitebsk

3178 Orsoten orlistat capsules

120mg,


21/1x21/, 42/6x7/,

42/2x21/)

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500

Russia A08AB01 1557912.05.2016

12.05.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3179 Ortophendiclofenac

(diclofenac sodium)

tablets gastro-

resistant

25mg,


PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region

Ukraine M01AB05 1706605.10.2017

05.10.2022PoM

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region, Ukraine

683

3180Ortophen

Tatpharm

diclofenac

(diclofenac sodium)

tablets gastro-

resistant

25mg,

blister (30/3x10/,

30/2x15/)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia M01AB05 13899/108.02.2017

30.09.2019PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

3181Ortophen-

Zdorovye

diclofenac

(diclofenac sodium)

tablets gastro-

resistant

25mg,


30/3x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine M01AB05 1674305.06.2017

05.06.2022PoM

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22,

Ukraine

3182 Orungal itraconazole capsules100mg,


Janssen Cilag S.p.A.,

Via C. Janssen, Borgo

San Michele, 04100

Latina

Italy J02AC02 13905/118.12.2014

17.10.2019PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

3183 Orunit itraconazole capsules100mg,

in blister (15)

S.C. Slavia Pharm

S.R.L., Bd. Theodor

Pallady No 44 C,

sector 3, Bucuresti,

032266

Romania J02AC02 1223207.03.2013

07.03.2018PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

No 1A, Romania

3184 OslaDex hydroxyethyl starch solution for infusion

60mg/ml,

100ml, 200ml, 500ml

plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

Armenia B05AA07 16880

08.08.2017

08.08.2022PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

3185 Ospamox

amoxicillin

(amoxicillin

trihydrate)

powder for oral

suspension

250mg/5ml,

60ml glass bottle

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl

Austria J01CA04 1539226.02.2016

26.02.2021PoM

Sandoz GmbH,


A-6250 Kundl,

Austria

684

3186 Ospamox

amoxicillin

(amoxicillin

trihydrate)

powder for oral

suspension

125mg/5ml,

60ml glass bottle

Sandoz GmbH,


A-6250 Kundl

Austria J01CA04 1539326.02.2016

26.02.2021PoM

Sandoz GmbH,


A-6250 Kundl,

Austria

3187 Ostalon

alendronic acid

(alendronate

sodium trihydrate)

tablets film-coated70mg,

in blister (4/1x4/)

Gedeon Richter

Polska Sp. z o.o., ul.

Ks. J. Poniatowskiego

5, Grodzisk

Mazowiecki, 05-825-

batch releaser,

Gedeon Richter


Graniczna 35,

Grodzisk Mazowiecki,

05-825, Poland-bulk

manufacturer,

packager

Poland M05BA04 1624819.12.2016

19.12.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3188 Osteogenon

ossein-

hydroxyapatite

compound



Pierre Fabre

Medicament

Production, site

Progipharm, Rue du

Lycee, 45500 Gien

France M05BX 1553519.04.2016

19.04.2021PoM

Pierre Fabre

Medicament

Production, 45, place

Abel Gance, 92100

Boulogne, France

3189 Ostiral

raloxifene

(raloxifene

hydrochloride)



Pharmathen

International S.A.,

Industrial Park Sapes,

Rodopi Prefecture,

Block No 5, Rodopi

69300

Greece G03XC01 15410/116.11.2016

09.03.2021PoM

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki, Greece

685

3190 Otibru

phenazone,

lidocaine (lidocaine

hydrochloride)

solution (ear drops)

45.52mg/ml+

11.38mg/ml,

15ml plastic bottle-

dropper

Brupharmexport sprl,

Rue de la Grotte, 14,

B-1020, Brussels-

batch releaser, S.C.

Rompharm Company

S.R.L., Ilfov, 75100


Nr. 1A, Romania -

bulk manufacturer,

packager

Belgium N01BB52 1440516.04.2015

16.04.2020OTC



B-1020, Brussels,

Belgium

3191 Oticaine

phenazone,


hydrochloride)

drops ear40mg/g+10mg/g, 5g and

15g plastic bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaSO2DA 13948

29.10.2014

29.10.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

3192 Otipax

phenazone,


hydrochloride)

drops ear

40mg/g+10mg/g,

15ml (16g) glass vial and

dropper

Biocodex,1 avenue

Blaise Pascal, 60000

Beauvais for

Biocodex, 7 avenue

Gallieni 94250

Gentilly, France

France S02DA 1712516.11.2017

16.11.2022OTC

Biocodex,1 avenue


Beauvais for

Biocodex, 7 avenue

Gallieni 94250

Gentilly, France

3193 Otirelax

phenazone,


hydrochloride)

drops ear

40mg/g+10mg/g,


dropper

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania S02DA30 1645206.03.2017

06.03.2022OTC

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

3194 Otofarifamycin

(rifamycin sodium)drops ear

26mg (20000IU)/ml, 10ml

glass bottle with dropper

Laboratoires Bouchara-

Recordati 68 Rue

Marjolin 92300

Levallois Perret

France S02AA12 1416524.12.2014

24.12.2019PoM

Laboratoires

Bouchara-Recordati

68 Rue Marjolin

92300 Levallois

Perret, France

686

3195 Otofarifamycin

(rifamycin sodium)drops ear

26mg (20000IU)/ml,

10ml glass bottle with

dropper


Recordati, Immeuble

"le Wilson", 70

avenue du General de

Gaulle, 92800

Puteaux- batch

releaser, Pharmaster,

Zone Industrielle de

Krafft, 67150 Erstein,

France- bulk

manufacturer,

packager

France S02AA12 1660910.04.2017

10.04.2022PoM

Laboratoires

Bouchara-Recordati,

Immeuble "le

Wilson", 70 avenue

du General de Gaulle,

92800 Puteaux,

France

3196

Otofix

40mg/g+10mg/g

ear drops, solution

phenazone,


hydrochloride)

drops ear (solution)

40mg/g+10mg/g, 15ml

glass bottle and dropper

applicator

Unipharm JSC, 3

Traiko Stanoev Str.,

Sofia 1797

Bulgaria S02DA30 1562624.05.2016

24.05.2021OTC

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

3197 Otoralgin

nitrofurazone,

phenazone,


hydrochloride)

drops ear2mg/g+70mg/g+ 25mg/g,

5g and 15g plastic bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaS02D 13864

18.09.2014

18.09.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3198 Otrepin-Arpi

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

1mg/ml,

15ml plastic bottle with

pump dispenser

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaR01АA07 16846

10.07.2017

10.07.2022OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3199 Otrivin

xylometazoline

(xylometazoline

hydrochloride)

drops nasal0,5mg/ml,

10ml plastic container

Novartis Consumer

Health S.A., Route de

IÈtraz, Case postale

269, 1260 Nyon

Switzerland R01AA07 1320931.01.2014

31.01.2019OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

687

3200 Otrivin

xylometazoline

(xylometazoline

hydrochloride)

spray nasal1mg/ml,


Novartis Consumer



269, 1260 Nyon


31.01.2019OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

3201 Otrivin

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

1mg/ml,

10ml plastic vial with

metering pump

Novartis Consumer



269, 1260 Nyon


17.10.2021OTC

Novartis Consumer

Health Schweiz S.A.,

6343 Rish,

Switzerland

3202 Ova-mitclomifene

(clomifene citrate)tablets

50mg,


Remedica Ltd,

Limassol Industrial

Estate, Aharnon

street, 3056 Limassol

Cyprus G03GB02 1421612.02.2015

12.02.2020PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

3203 Ovitrellechoriogonadotro-

phin alfa

solution for s/c

injection

250mcg/0,5ml, glass pre-

filled syringewith needle,

in plastic pack

Merck Serono S.p.A.,

Via delle Magnolie

15, (loc. Frazione

Zona Industriale),

70026 Modugno,(BA)

Italy G03GA08 1303725.11.2013

25.11.2018PoM

Merck Serono Europe

Limited, 56 Marsh

Wall, London E14

9TR, UK

3204 Oxaliplatin oxaliplatin

powder lyophilized

for solution for

infusion

100mg,

glass bottle or vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01XA03 1565908.06.2016

08.06.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

3205 Oxaliplatin oxaliplatin

powder lyophilized

for solution for

infusion

50mg,

glass bottle or vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01XA03 1566008.06.2016

08.06.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

688

3206

Oxaliplatin 5mg/ml

Concentrate for

Solution for

Infusion

oxaliplatinconcentrate for

solution for infusion

5mg/ml,

40ml glass vial (1)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK L01XA03 1516317.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3207

Oxaliplatin 5mg/ml

Concentrate for

Solution for

Infusion



5mg/ml,

40ml glass vial (1)

Accord Healthcare

Limited, Sage House,319

Pinner Road, North


4HF- batch releaser, Intas


Plot No 5/6/7, Pharmez,

Near Village Matoda,

Sarkhej-Bavla Highway,

NH-8A, Matoda, District-

Ahmedabad, 382 210,








packager

UK L01XA03 1516417.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

689

3208

Oxaliplatin 5mg/ml

Concentrate for

Solution for

Infusion



5mg/ml,

20ml glass vial (1)

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK L01XA03 1516517.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3209

Oxaliplatin 5mg/ml

Concentrate for

Solution for

Infusion



5mg/ml,

20ml glass vial (1)

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK L01XA03 1516617.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

690

3210

Oxaliplatin 5mg/ml

Concentrate for

Solution for

Infusion



5mg/ml,

10ml glass vial (1)

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK L01XA03 1516717.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3211

Oxaliplatin 5mg/ml

Concentrate for

Solution for

Infusion



5mg/ml,

10ml glass vial (1)

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK L01XA03 1516817.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

691

3212 Oxaliplatin Ebewe oxaliplatin

powder lyophilized

for solution for

infusion

50mg,

10ml glass vial

EBEWE Pharma Ges.

m.b.H. Nfg. KG

(Mondseestrasse 11, A-

4866 Unterach am

Attersee) - batch

releaser, secondary

packager (dosage form

manufacturer,

primary packager -

Oncotec Pharma

Produktion GmbH

/Am Pharmapark, D-

06861 Dessau-

Rosslau, Saxony-

Anhalt, Germany/)

Austria L01XA03 1291907.10.2013

07.10.2018PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG


4866 Unterach am

Attersee, Austria)

3213 Oxaliplatin Ebewe oxaliplatinpowder for solution

for infusion

100mg,

20ml glass vial

EBEWE Pharma Ges.

m.b.H. Nfg. KG


4866 Unterach am

Attersee) - batch

releaser, secondary


manufacturer,

primary packager -

Oncotec Pharma

Produktion GmbH

/Am Pharmapark, D-

06861 Dessau-

Rosslau, Saxony-

Anhalt, Germany/)

Austria L01XA03 1292007.10.2013

07.10.2018PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG


4866 Unterach am

Attersee, Austria)

3214 Oxaliplatin-Teva oxaliplatinconcentrate for


5mg/ml,

20ml glass vial

Teva Pharmaceutical

Works Private

Limited Company, H-

2100 Godollo,


Hungary L01XA03 1412229.12.2014

29.12.2019PoM

Teva Pharmaceutical

Industries Ltd., 5


3190, Petach Tikva,

49131, Israel

692

3215 Oxaliplatin-Teva oxaliplatinconcentrate for


5mg/ml,

10ml glass vial

Teva Pharmaceutical

Works Private

Limited Company, H-

2100 Godollo,


Hungary L01XA03 1412329.12.2014

29.12.2019PoM

Teva Pharmaceutical

Industries Ltd., 5


3190, Petach Tikva,

49131, Israel

3216Oxaliplatin-Teva

5mg/mloxaliplatin

concentrate for


5mg/ml,

10ml glass vial

Pharmachemie B.V.,

Swensweg 5, 2031 GA

Haarlem for

the Netherlands L01XA03 1406019.12.2014

19.12.2019PoM

Teva Pharmaceutical

Industries Ltd., 5


3190, 49131 Petach

Tikva, Israel

3217Oxaliplatin-Teva

5mg/mloxaliplatin

concentrate for


5mg/ml,

20ml glass vial

Pharmachemie B.V.,

Swensweg 5, 2031 GA

Haarlem

the Netherlands L01XA03 1406119.12.2014

19.12.2019PoM

Teva Pharmaceutical

Industries Ltd., 5


3190, 49131 Petach

Tikva, Israel

3218Oxitetraciclin

200LAoxytetracycline solution for injection

200mg/ml; 10ml, 50ml

and 100ml glass vials

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de

Llobregat, Barcelona,

Esmeralda 19

Spain

QJ01AA06

veterinary

drug

13006/117.11.2014

14.11.2018PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

3219 Oxivin-DF

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal

0,5mg/ml,


pump dispenser

Dosfarm LLP, 050034,

Almaty city,

Chaplygin str.3

Kazakhstan R01AA05 1705605.10.2017

05.10.2022OTC


Almaty city,

Chaplygin str.3,

Kazakhstan

3220 Oxivin-DF

oxymetazoline

(oxymetazoline

hydrochloride)

drops nasal

0,5mg/ml,


dropper


Almaty city,

Chaplygin str.3

Kazakhstan R01AA05 1705705.10.2017

05.10.2022OTC


Almaty city,

Chaplygin str.3,

Kazakhstan

693

3221 Oxolin oxolin ointment nasal2,5mg/g,

10g in aluminium tube

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia J05AX 1287419.09.2013

19.09.2018OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

3222 Oxolin oxolin ointment2,5mg/g,

15g aluminium tube

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30)

Belarus D06BB 1291507.10.2013

07.10.2018OTC

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30,

Belarus)

3223 Oxolin oxolin ointment nasal2,5mg/g,

10g aluminium tube

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia J05AX 1703326.09.2017

26.09.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

3224 Oxolin-AV oxolin ointment nasal2,5mg/g,

10g aluminium tube

"Altayvitaminy" CJSC

659325, Altay region,

Biysk, st. Zavodskaya,

69

Russia J05AX 1578820.07.2016

20.07.2021OTC




69, Russia

3225 Oxybactocid

oxytetracycline

(oxytetracycline

hydrochloride)

powder85%,

5g sachet

Agrobioprom CJSC,

143985, Moscow,

Balashikhinski

district,,Novo-Milet

r/d , Poltevskoe shosse

, 4

Russia

QJ01AA06;

veterinary

drug

1647906.03.2017

06.03.2022OTC

Agrobioprom CJSC,

107139, Moscow,

pereulok

Orlikov,house 3,

Russia

3226 Oxybral vincaminecapsules sustained-

release

30mg,


GlaxoSmithKline

S.A.E., El-Salam City

11491, Cairo

Egypt C04AX07 1450215.05.2015

15.05.2020PoM

GlaxoSmithKline

S.A.E., El-Salam City

11491, Cairo, Egypt

694

3227 Oxycort

oxytetracycline

(oxytetracycline

hydrochloride),

hydrocortisone

(hydrocortisone

acetate)

ointment for

external use

30mg/g+10mg/g, 10g

aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07CA01 1553819.04.2016

19.04.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

3228Oxyprogesterone

caproate

hydroxyprogeste-

rone

(hydroxyprogeste-

rone caproate)

solution oil for

injection

125mg/ml,

1ml ampoules (10)

Biopharma PJSC

(03680, Kiev, N.

Amosova str. 9)

Ukraine G03DA03 1293507.10.2013

07.10.2018PoM

Biopharma PJSC

(03680, Kiev, N.

Amosova str. 9,

Ukraine)

3229Oxyprogesterone

capronate

hydroxyprogesteron

e

(hydroxyprogestero

ne caproate)

solution oil for

injection

125mg/ml,

1ml ampoules,


"BIOFARMA" "PP"

LLC, 37, Kyivska Str.,

Bila Tserkva, 09100,

Kyiv region

Ukraine G03DA03 1666111.05.2017

11.05.2022PoM

"BIOFARMA" "PP"



Kyiv region, Ukraine

3230Oxytetracycline

10%

oxytetracycline

(oxytetracycline

hydrochloride)


100ml glass vial (12)

Alfasan International

B.V., Kuipersweg 9-

3449 JA Woerden

the Netherlands

QD06AA03;

veterinary

drug

1532504.02.2016

04.02.2021PoM

Alfasan International

BV, P.O. Box 78, 3440

AB Woerden, the

Netherlands

3231 Oxytocin oxytocin solution for injection

10U/ml,

5ml ampoules (10), 20ml,

50ml, 100ml and 100ml

glass vial

"Brovafarma" Ltd,18-

a, Nezalezhnosti

blvd., Brovary, Kyiv

region, 07400

Ukraine

QH01BB02;

veterinary

drug

1457809.06.2015

09.06.2020PoM

"Brovafarma" Ltd,18-

a, Nezalezhnosti

blvd., Brovary, Kyiv

region, 07400,

Ukraine

3232 Oxytocin oxytocin solution for injection

5IU/ml,

1ml ampoules,


"Sintez" OJSC, Pr.

Konstitutsii, No. 7,

Kurgan, 640008

Russia H01BB02 1721908.12.2017

08.12.2022PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

695

3233 Oxytocin Grindeks oxytocin solution for injection

5IU/ml,

1ml ampoules,


Grindeks JSC,

Krustpils street 53, LV-

1057, Riga- batch

releaser, Santonika

UAB, 134B Veiveriu

street,Kaunas, LT-

46352, Lithuania-bulk

manufacturer,

packager

Latvia H01BB02 1637030.12.2016

30.12.2021PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

3234 Oxytocin Grindeks oxytocin solution for injection5IU/ml,

1ml ampoules (10/2x5/)

Grindeks JSC,


1057, Riga- batch

releaser, HBM

Pharma s.r.o.,

Sklabinska 30, 03680

Martin, Slovakia-bulk

manufacturer,

packager

Latvia H01BB02 1681710.07.2017

10.07.2022PoM

Grindeks JSC,



3235 Oxytocin-20 oxytocin solution for injection20IU/ml,

50ml glass bottle

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray-

secondary packager,

Interchemie werken

De Adelaar Eesti AS,

Vanapere tee 14,

Viimsi, Harju county,

Estonia- bulk

manufacturer,

primary packager,

batch releaser

the Netherlands

H01BB02;

veterinary

drug

1479204.09.2015

04.09.2020PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

3236 Oxytocin-Richter oxytocinsolution for i/v and

i/m injection

5IU/ml,

1ml ampoules (5)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary H01BB02 1392729.10.2014

29.10.2019PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

696

3237

Ozapex 10mg

orodispersible

tablets

olanzapine tablets orodispersible10mg,


Pharmathen S.A.,


Pallini, Attiki

Greece N05AH03 1384718.09.2014

18.09.2019PoM

Pharmathen Hellas

S.A., 144, Marathonos

Avenue, 15351


3238

Ozapex 5mg

orodispersible

tablets



Pharmathen S.A.,


Pallini, Attiki

Greece N05AH03 1384618.09.2014

18.09.2019PoM

Pharmathen Hellas

S.A., 144, Marathonos

Avenue, 15351


3239Pabi-

Dexamethasondexamethasone tablets

500mcg,

in glass bottle (20) and in

blister (20/1x20/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

Poland H02AB02 1644406.03.2017

06.03.2022PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice, Poland

3240 Paclitaxel paclitaxelconcentrate for


30mg/5ml,

5ml glass vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01CD01 1617223.11.2016

23.11.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

3241 Paclitaxel paclitaxelconcentrate for


100mg/16,7ml, 16.7ml

glass vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01CD01 1617323.11.2016

23.11.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

697

3242

Paclitaxel 6mg/ml

concentrate for

solution for

infusion

paclitaxelconcentrate for


6mg/ml,

50ml glass vial (1)

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,


manufacturer, primary

packager, Accord





secondary packager

UK L01CD01 1453804.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3243

Paclitaxel 6mg/ml

concentrate for

solution for

infusion



6mg/ml,

25ml glass vial (1)

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,



packager, Accord





secondary packager

UK L01CD01 1453904.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

698

3244

Paclitaxel 6mg/ml

concentrate for

solution for

infusion



6mg/ml,

16.7ml glass vial (1)

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,



packager, Accord





secondary packager

UK L01CD01 1454004.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3245

Paclitaxel 6mg/ml

concentrate for

solution for

infusion



6mg/m,

5ml glass vial (1)

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,



packager, Accord





secondary packager

UK L01CD01 1454104.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

699

3246

Paclitaxel 6mg/ml

concentrate for

solution for

infusion



6mg/ml,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,



packager, Accord





secondary packager

UK L01CD01 1454204.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3247

Paclitaxel 6mg/ml

concentrate for

solution for

infusion



6mg/ml,


Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,



packager, Accord





secondary packager

UK L01CD01 1454304.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

700

3248

Paclitaxel 6mg/ml

concentrate for

solution for

infusion



6mg/ml,

50ml glass vial (1)

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,



packager, Accord





secondary packager

UK L01CD01 1454404.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3249

Paclitaxel 6mg/ml

concentrate for

solution for

infusion



6mg/ml,

25ml glass vial (1)

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,



packager, Accord





secondary packager

UK L01CD01 1454504.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

701

3250

Paclitaxel 6mg/ml

concentrate for

solution for

infusion



6mg/ml,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,



packager, Accord





secondary packager

UK L01CD01 1454604.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3251

Paclitaxel 6mg/ml

concentrate for

solution for

infusion



6mg/ml,

5ml glass vial (1)

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,



packager, Accord





secondary packager

UK L01CD01 1454704.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

702

3252Paclitaxel

Moosmann 6mg/mlpaclitaxel

concentrate for


6mg/ml,

16,7ml glass vial

Actavis Italy S.p.A.,

Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01CD01 1569522.06.2016

22.06.2021PoM

Moosmann

Pharmaceuticals LLC,

Vanahovit 8,

Proshyan v., Ashtarak

Ave., Kotayk Marz

2413, Republic of

Armenia

3253Paclitaxel


concentrate for


6mg/ml,

5ml glass vial


Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01CD01 1569622.06.2016

22.06.2021PoM

Moosmann


Vanahovit 8,


Ave., Kotayk Marz

2413, Republic of

Armenia

3254Paclitaxel


concentrate for


6mg/ml,

25ml glass vial


Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01CD01 1569722.06.2016

22.06.2021PoM

Moosmann


Vanahovit 8,


Ave., Kotayk Marz

2413, Republic of

Armenia

3255Paclitaxel


concentrate for


6mg/ml,

50ml glass vial


Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01CD01 1569822.06.2016

22.06.2021PoM

Moosmann


Vanahovit 8,


Ave., Kotayk Marz

2413, Republic of

Armenia

703

3256 Paclitaxel-Ebewe paclitaxelconcentrate for


6mg/ml,

5ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01CD01 1400226.11.2014

26.11.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria



6mg/ml,

16,7ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01CD01 1400326.11.2014

26.11.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria



6mg/ml,

25ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01CD01 1400426.11.2014

26.11.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria



6mg/ml,

35ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01CD01 1400526.11.2014

26.11.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria



6mg/ml,

50ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01CD01 1400626.11.2014

26.11.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

704

3261 Paclitaxel-Teva paclitaxelconcentrate for


6mg/ml,

5ml glass vial (1)

Pharmachemie B.V.

Swensweg 5, NL 2031

GA Haarlem

the Netherlands L01CD01 1382518.09.2014

18.09.2019PoM

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel



6mg/ml,

16,7ml glass vial (1)

Pharmachemie B.V.

Swensweg 5, NL 2031

GA Haarlem


18.09.2019PoM

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel



6mg/ml,

25ml glass vial (1)

Pharmachemie B.V.

Swensweg 5, NL 2031

GA Haarlem


18.09.2019PoM

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel



6mg/ml,

50ml glass vial (1)

Pharmachemie B.V.

Swensweg 5, NL 2031

GA Haarlem


18.09.2019PoM

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel

3265 Palin

pipemidic acid

(pipemidic acid

trihydrate)

capsules200mg,


Lek Pharmaceuticals

d.d. Verovskova Str.

57, 1526 Ljubljana

Slovenia J01MB04 1417921.01.2015

21.01.2020PoM

Lek Pharmaceuticals

d.d. Verovskova Str.

57, 1526 Ljubljana,

Slovenia

705

3266Pamiray 370

Injectioniopamidol solution for injection

370mg iodine/ml, 100ml

glass vial

DongKook

Pharmaceutical Co.,

Ltd., 488-5, Jukhyeon-

ri, Gwanghyewon-

myeon, Jincheon-gun,

Choongcheongbuk-do

Korea Sourth V08AB04 1287319.09.2013

19.09.2018PoM

DongKook

Pharmaceutical Co.

Ltd., 997-8, Daechi-

2dong, Gangnam-gu,

Seoul, Korea

3267 Panadol paracetamol tablets film-coated500mg,


S.C. Europharm S.A.,

2 Panselelor str.,

Brasov, county of

Brasov, 500419 -

packager, batch

releaser,

GlaxoSmithKline

Dungarvan Ltd.,

Knockbrack,

Dungarvan, County

Waterford, Ireland -

bulk manufacturer

Romania N02BE01 1449415.05.2015

15.05.2020OTC

GlaxoSmithKline

Consumer

HealthCare, 980

Great West Road,

Brentford, Middlesex,

TW8 9GS, UK

3268 Panadol Advance paracetamol tablets film-coated500mg,

in blister (12)

S.C. Europharm S.A.,

2 Panselelor str.,

Brasov, county of

Brasov, 500419 -

packager, batch

releaser (dosage form

manufacturer -

SmithKline Beecham

(Dungarvan) Limited,

Knockbrack,

Dungarvan, County

Waterford, Ireland)

Romania N02BE01 1275314.08.2013

14.08.2018OTC

GlaxoSmithKline

Consumer

Healthcare, 980 Great

West Road,

Brentford,

Middlesex,TW8 9GS,

UK

706

3269 Panadol Baby paracetamol suspension oral

120mg/5ml,


measuring syringe

Farmaclair, 440

Avenue du General

de Gaulle, 14200

Herouville Saint Clair

France N02BE01 1545602.04.2016

02.04.2021OTC

GlaxoSmithKline

Consumer

Healhtcare, 980 Great

West Road,


TW8 9GS, UK

3270 Panadol Baby paracetamol suppositories rectal125mg,

(10/2x5/)

Farmaclair, 440

Avenue du General

de Gaulle, 14200

Herouville Saint Clair

France N02BE01 1558812.05.2016

12.05.2021OTC

GlaxoSmithKline

Sante Grand Public,

100, route de

Versailles, B.P .23,

78164 Marly-Le-Roi

Cedex, France

3271 Panadol Extraparacetamol,

caffeinetablets film-coated

500mg+65mg,


GlaxoSmithKline

Dungarvan Limited,

Knockbrack,

Dungarvan, County

Waterford

Ireland N02BE71 15513/104.05.2017

19.04.2021OTC

GlaxoSmithKline

Consumer


West Road,


TW8 9GS, UK

3272 Panangin

magnesium

aspartate

(magnesium

aspartate

tetrahydrate),

potassium aspartate

(potassium aspartate

hemihydrate)

concentrate for


40mg/ml+ 45.2mg/ml,

10ml ampoules, in blister

(5/1x5/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary B05BB01 1456209.06.2015

09.06.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

707

3273 Panangin

magnesium

aspartate

(magnesium

aspartate

tetrahydrate),

potassium aspartate

(potassium aspartate

hemihydrate)

tablets film-coated140mg+158mg,

in plastic container (50)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary A12CC30 1532604.02.2016

04.02.2021OTC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3274 Panangin Forte

potassium

asparaginate

(potassium

asparaginate

hemihydrate),

magnesium

asparaginate

(magnesium

asparaginate

tetrahydrate)

tablets film-coated

316mg+280mg,


60/4x15/, 90/6x15/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary A12CX 1693805.09.2017

05.09.2022OTC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3275 Panataxel paclitaxelconcentrate for


150mg/vial,

25ml glass vial (1)

Laboratorios IMA

S.A.I.C., Palpa 2862,

Ciudad Autonoma De

Buenos Aires

Argentina L01CD01 1533226.02.2016

26.02.2021PoM

Bioprofarma S.A.,

Terrada 1270, Ciudad

Autonoma de Buenos

Aires, Argentina



300mg/vial,

50ml glass vial (1) and

infusion set (1)

Laboratorios IMA


Ciudad Autonoma De

Buenos Aires

Argentina L01CD01 1533326.02.2016

26.02.2021PoM

Bioprofarma S.A.,


Autonoma de Buenos

Aires, Argentina

708



100mg/vial,


Laboratorios IMA


Ciudad Autonoma De

Buenos Aires

Argentina L01CD01 1533426.02.2016

26.02.2021PoM

Bioprofarma S.A.,


Autonoma de Buenos

Aires, Argentina



30mg/vial,

5ml glass vial (1)

Laboratorios IMA


Ciudad Autonoma De

Buenos Aires

Argentina L01CD01 1533526.02.2016

26.02.2021PoM

Bioprofarma S.A.,


Autonoma de Buenos

Aires, Argentina

3279 Pancefcefixime (cefixime

trihydrate)

powder for oral

suspension

100mg/5ml,

32g powder in glass bottle

60ml and measuring

spoon 5ml

Alkaloid AD-Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje-batch releaser,

Alkaloid AD-Skopje,

Blvd. Partizanski

odredi 98A,1000

Skopje, Macedonia-

bulk manufacturer,

packager

Macedonia J01DD08 1471416.07.2015

16.07.2020PoM

Alkaloid AD-Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia


trihydrate)tablets film-coated

400mg,

in blister (5/1x5/, 7/1x7/,

10/2x5/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000


Alkaloid AD-Skopje,

Blvd. Partizanski

odredi 98A,1000

Skopje, Macedonia-

bulk manufacturer,

packager

Macedonia J01DD08 1708105.10.2017

05.10.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

709


trihydrate)

powder for oral

suspension

100mg/5ml,

53g powder in 100ml

glass bottle and 5ml

measuring spoon

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000


Alkaloid AD-Skopje,

Blvd. Partizanski

odredi 98A,1000

Skopje, Macedonia-

bulk manufacturer,

packager

Macedonia J01DD08 1708205.10.2017

05.10.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

3282

Pancef 100mg/5ml

powder for oral

suspension

cefixime (cefixime

trihydrate)

powder for oral

suspension

20mg/ml,

100ml glass bottle

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar

Makedonski 12, 1000,

Skopje, Macedonia)

Slovenia J01DD08 1241023.04.2013

23.04.2018PoM


Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

3283Pancef 400mg film-

coated tablets

cefixime (cefixime

trihydrate)tablets film-coated

400mg,



Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia)

Slovenia J01DD08 1240923.04.2013

23.04.2018PoM


Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

710

3284 Pancreatin

pancreatin

(amylase,protease,

lipase)

tablets gastro-

resistant

125mg (not less than

2800IU, not less than

180IU, not less than

3000IU),


Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A09AA02 1681422.06.2017

22.06.2022OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

3285 Pangrol 10000pancreatin (lipase,

amylase, protease)

capsules hard gastro-

resistant

10000U+not less

than9000U+not less than

500U,


Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser, Adare

Pharmaceuticals Srl.,

Via Martin Luther

King, 13, Pessano Con

Bornago, 20060, Italy-

bulk manufacturer,

Artesan Pharma

GmbH & Co. KG,

Albrecht-Thaer-Str. 9,

29439 Luchow,

Germany-packager

Germany A09AA02 1605017.10.2016

17.10.2021OTC

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

3286 Pangrol 25000pancreatin (lipase,

amylase, protease)


resistant

25000U+not less than

22500U+not less than

1250U, plastic container

(20)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser, Adare

Pharmaceuticals Srl.,

Via Martin Luther

King, 13, Pessano Con

Bornago, 20060, Italy-

bulk manufacturer,

Artesan Pharma

GmbH & Co. KG,

Albrecht-Thaer-Str. 9,

29439 Luchow,

Germany-packager

Germany A09AA02 1605117.10.2016

17.10.2021OTC

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

711

3287 Panklav 2X

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)


in glass container (14)

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.,

Vrsac, 26224,

Dubovac, str. Cara

Lazara bb, Serbia-bulk

manufacturer,

packager

Serbia J01CR02 1619608.12.2016

08.12.2021PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

3288 Pankreoflat

pancreatin

(protease, amylase,

lipase), dimeticone

tablets coated

170mg(400U+

5500U+6500U)+ 80mg,


Pharmaselect

International

Beteiligungs GmbH,

Ernst-Melchior-Gasse

20, 1020 Vienna -

batch releaser (dosage

form manufacturer -

Haupt Pharma

Amareg GmbH,

Donaustaufer Strasse

378 93055

Regensburg,

Germany)

Austria A09AA02 1271023.07.2013

23.07.2018OTC

Pharmaselect

International

Beteiligungs GmbH,

Ernst-Melchior-Gasse

20, 1020 Vienna,

Austria

3289 PanPure

pantoprazole

(pantoprazole

sodium)

tablets enteric-

coated

20mg,


Emcure

Pharmaceuticals Ltd.,

Lane No. 3, Phase II,

SIDCO Industrial

Complex, Bari-

Brahmana, Jammu

(J&K)-181 133

India A02BC02 1321424.02.2014

24.02.2019PoM

Emcure


T-184, M.I.D.C.,

Bhosari, Pune-

411026, Maharashtra,

India

3290Panthenol

Pharmstandarddexpanthenol aerosol

50mg/g,

58g glass or plastic

container

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18

Russia D03AX03 1409618.12.2014

18.12.2019OTC

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18, Russia

712

3291 Panthron pantoprazole

tablets delayed

release gastro-

resistant

40mg,


Eris Pharmaceuticals

Pty LTD, 6 Eastern

road South

Melbourne, Victoria,

3205 - batch releaser

(IPCA Laboratories

Ltd, Plot No 255/1

Village Athal Silvassa

Dadra and Nagar

Haveli 396 230, India -

bulk manufacturer,

packager)

Australia A02BC02 13714/103.10.2014

24.07.2019PoM


Pty LTD, 6 Eastern

road South


3205, Australia

3292 Panthron pantoprazole

tablets delayed

release gastro-

resistant

20mg,



Pty LTD, 6 Eastern

road, South


3205 - batch releaser,

IPCA Laboratories

Ltd, Plot No 255/1

Village Athal Silvassa

Dadra and Nagar

Haveli 396 230, India-

bulk manufacturer,

packager

Australia A02BC02 1461903.07.2015

03.07.2020PoM


Pty LTD, 6 Eastern

road, South


3205, Australia

3293 Pantocrin

red deer and

Manchurian deer

antlers

extract oral liquid100mg/ml,

50ml glass bottle

Pharmstandard-

Tomskchimpharm

OJSC, 634009, Tomsk,

avenue Lenina, 211

Russia A13A 1447530.04.2015

30.04.2020OTC

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211,

Russia

3294 Panto-Denk 20

pantoprazole

(pantoprazole

sodium

sesquihydrate)

tablets gastro-

resistant

20mg,


Advance Pharma

GmbH, Wallenroder

Strasse 12-14, 13435

Berlin

Germany A02BC02 1255106.06.2013

06.06.2018PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Munchen,

Germany

713

3295 Panto-Denk 40

pantoprazole

(pantoprazole

sodium

sesquihydrate)

tablets gastro-

resistant

40mg,


Advance Pharma

GmbH, Wallenroder

Strasse 12-14, 13435

Berlin

Germany A02BC02 1255206.06.2013

06.06.2018PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

3296 Pantoderm dexpanthenolointment for

external use

50mg/g,

30g aluminium tube

Akrikhin

Pharmaceuticals Co.,

142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia D03AX03 1638324.01.2017

24.01.2022OTC

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia

3297 Panto-DR

pantoprazole

(pantoprazole

sodium)

tablets gastro-

resistant

40mg,


20/2x10/)

Tufenkji Group LLC,

Kochinyan 13/16,

Yerevan- batch

releaser, packager,

Zim Laboratories Ltd.,

B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.),

India- bulk

manufacturer

Republic of

ArmeniaA02BC02 16956

05.09.2017

05.09.2022PoM

Tufenkji Group LLC,

Kochinyan 13/16,

Yerevan, Republic of

Armenia

3298 Pantogam

hopantenic acid

(calcium

hopantenate)

tablets250mg,


"PIQ-PHARMA LEK"

LLC, 46g,

Beryozovaya str.,

Severnyj-Pervyj

town, Belgorod

district, Belgorod

region, 308570

Russia 1508215.12.2015

15.12.2020PoM

PIQ-PHARMA LLC,

125047, pereulok

Oruzheyniy, 25,

building 1,

Moscow,Russia

3299 Panzynorm 10000pancreatin (lipase,

amylase, protease)


resistant

10000U+7200U+ 400U,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A09AA02 1491420.10.2015

20.10.2020OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

714

3300Panzynorm forte

20 000

pancreatin (lipase,

amylase, protease)

tablets gastro-

resistant coated

20000U+12000U+ 900U,


30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A09AA02 1370924.07.2014

24.07.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3301 Papaverin

papaverine

(papaverine

hydrochloride)

suppositories rectal20mg

(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia A03AD01 1679522.06.2017

22.06.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

3302Papaverine -

Darnitsa

papaverine

(papaverine

hydrochloride)

solution for injection

20mg/ml,

2ml ampoules,

in blister (10, 10/2x5/)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya Str.,13

Ukraine A03AD01 1234509.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

3303Papaverine

hydrochloride

papaverine

(papaverine

hydrochloride)


20mg/ml,

2ml ampoules label

banderol (10), 2ml

ampoules, in blister

(10/1x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus A03AD01 1603317.10.2016

17.10.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

3304Papaverine-

Zdorovye

papaverine

(papaverine

hydrochloride)

tablets

10mg,


10/1x10/)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine A03AD01 1643206.03.2017

06.03.2022PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

715

3305 Papazol

papaverine

hydrochloride,

bendazol

hydrochloride

tablets30mg+30mg,

in strip (10/1x10/)

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211

Russia A03AD 1442514.04.2015

14.04.2020PoM

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211,

Russia

3306 Parabrufen ibuprofen tablets film-coated600mg,


Tufenkji Group LLC,

Kochinyan 13/16,

Yerevan- batch

releaser, packager,


B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.),

India- bulk

manufacturer

Republic of

ArmeniaM01AE01 16952

05.09.2017

05.09.2022PoM

Tufenkji Group LLC,

Kochinyan 13/16,


Armenia

3307 Paracetamol paracetamol tablets500mg,

in blister (10)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, K. Marksa

str., 124

Russia N02BE01 1304325.11.2013

25.11.2018OTC

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

3308 Paracetamol paracetamol tablets

500mg,


20/2x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia N02BE01 1360720.06.2014

20.06.2019OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

3309 Paracetamol paracetamol tablets500mg,

in blister (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN02BE01 14081

16.12.2014

16.12.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

716

3310 Paracetamol paracetamol tablets

500mg,

in strip (10),


Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus N02BE01 1625219.12.2016

19.12.2021OTC

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

3311 Paracetamol paracetamolsolution oral with

orange flavour

120mg/5ml,

60ml and 100ml glass

bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


21.12.2016

21.12.2021OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3312 Paracetamol paracetamol suppositories rectal250mg,


"Biohimik " PJSC,

Republic of Mordovia,

430030, Saransk,

Vasenko str., 15A

Russia N02BE01 1681910.07.2017

10.07.2022OTC

"PROMOMED RUS "

LLC, 101000,

Moscow, Arkhangelsk

pereulok,1, build.1,

Russia

3313 Paracetamol paracetamol suppositories rectal100mg,


"Biohimik " PJSC,


430030, Saransk,

Vasenko str., 15A

Russia N02BE01 1682010.07.2017

10.07.2022OTC

"PROMOMED RUS "

LLC, 101000,

Moscow, Arkhangelsk


Russia

717

3314Paracetamol

500mg Tabletsparacetamol tablets

500mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK N02BE01 1524930.12.2015

30.12.2020OTC

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3315Paracetamol for

childrenparacetamol

suspension oral with

orange flavour

120mg/5ml,

100ml, 200ml glass bottle

and measuring spoon

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia N02BE01 1455909.06.2015

09.06.2020OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

3316Paracetamol for

childrenparacetamol

suspension oral with

strawberry flavour

120mg/5ml,


measuring spoon or

measuring syringe

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia N02BE01 1676709.06.2017

09.06.2022OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

3317Paracetamol

Sopharmaparacetamol syrup

24mg/ml,

125ml glass or plastic

bottle and measuring cup

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia - batch


manufacturer,

packager - Sopharma

JSC, Vrabevo vlg.

5660, district of

Lovetch, Bulgaria)

Bulgaria N02BE01 13239/120.06.2014

24.02.2019OTC

Sopharma JSC, str.

Iliensko shosse 16,


718

3318

Paracetamol

Sopharma 500mg

tablets

paracetamol tablets500mg,


Sopharma JSC (str.

Iliensko shosse 16,

1220 Sofia) - batch


manufacturer -

Sopharma JSC

/Vrabevo vlg. 5660,

district of Lovetch,

Bulgaria/)

Bulgaria N02BE01 1299428.10.2013

28.10.2018OTC

Sopharma JSC (str.

Iliensko shosse 16,

1220 Sofia, Bulgaria)

3319 Paracetamol-Nika paracetamol solution for infusion10mg/ml,

(1) and (28)

Nika Pharmaceftica

Ltd, Zavodskaya Str.1,

office 33, Alba

Settlement, Nesvizh

District, Minsk

Region 222603- batch

releaser, secondary

packager, Nesvizh

Plant of Medical

Preparations OJSC,

Zavodskaya Str. 1,

Alba Settlement,

Nesvizh District,

Minsk Region,

222603, Belarus- bulk

manufacturer,

primary packager

Belarus N02BE01 15479/107.03.2017

02.04.2021PoM

Nika Pharmaceftica

Ltd, Zavodskaya Str.

1, office 33, Alba

Settlement, Nesvizh

District, Minsk

Region 222603,

Belarus

3320 Paralel

amlodipine

(amlodipine

besilate), lisinopril

(lisinopril

dihydrate)

tablets5mg+10mg,


Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus C09BB03 1558712.05.2016

12.05.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

719

3321 Paramolan paracetamol suppositories rectal125mg,

(5/1x5/)

Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels - batch


manufacturer,

packager - Farmalabor

Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-

194 Condeixa-a-Nova,

Portugal)

Belgium N02BE01 1482304.09.2015

04.09.2020OTC

Brupharmexport

SPRL, Rue de la

Grotte, 14, B-1020,

Brussels, Belgium

3322 Paramolan paracetamol suppositories rectal250mg,

(5/1x5/)

Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels - batch


manufacturer,


Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal)

Belgium N02BE01 1482404.09.2015

04.09.2020OTC

Brupharmexport

SPRL, Rue de la

Grotte, 14, B-1020,

Brussels, Belgium

720

3323 Paramolan paracetamol tablets500mg,




B-1020, Brussels -

batch releaser,

Farmalabor- Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal- bulk

manufacturer,

packager

Belgium N02BE01 1535626.02.2016

26.02.2021OTC



B-1020, Brussels,

Belgium

3324 Paramolan Cparacetamol,

ascorbic acid

powder for oral

solution

500mg+250mg,

3g sachets (20)

Brupharmexport

SPRL (14 Rue De la

Grotte, B-1020

Brussels) - batch

releaser (doage form

manufacturer,


Produtos

Farmaceuticos, S.A

/Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal/)

Belgium N02BE51 1295528.10.2013

28.10.2018OTC

Brupharmexport

SPRL (Rue de la

Grotte, 14, B-1020,

Brussels, Belgium)

721

3325 Pariet

rabeprazole

(rabeprazole

sodium)

tablets gastro-

resistant film-coated

10mg,

in blister (14)

Cilag AG,

Schaffhausen CH-

8205, Hochstrasse 201

- secondary packager,

batch releaser

(primary packager,

dosage form

manufacturer - Eisai

Co., Ltd, , Koishikawa

4-6-10, Bunkyo-ku,

Tokyo 112-8088,

Japan)

Switzerland A02BC04 1240219.04.2013

19.04.2018PoM

Johnson & Johnson

LLC, 121614, Moskva,

Str. Krylatskaya 17/ 2,

Russia

3326 Pariet

rabeprazole

(rabeprazole

sodium)

tablets gastro-


20mg,

blister (14/1x14/,

28/2x14/)

Cilag AG,

Schaffhausen CH-

8200, Hochstrasse

201, Switzerland

primary packager,

secondary packager,

batch releaser (Bushu

Pharmaceuticals, Ltd.,

Misato Factory, 950,

Hiroki, Ohaza, Misato-

machi, Kodama-gun,

Saitama-ken, Japan -

bulk manufacturer)

Switzerland A02BC04 12403/316.12.2016

19.04.2018PoM

Johnson & Johnson

LLC, 121614, Moskva,

Str. Krylatskaya 17/ 2,

Russia

3327 Pariva paracetamol solution for infusion10mg/ml,

50ml, 100ml plastic pack

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of


17.09.2013

17.09.2018PoM

PharmaTech CJSC,


str. 111, Republic of

Armenia

3328 Parlazincetirizine (cetirizine

dihydrochloride)film-coated tablets

10mg,


30/3x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary R06AE07 15292/125.04.2017

04.02.2021OTC


PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

722


dihydrochloride)film-coated tablets

10mg,


30/3x10/)


PLC 9900, Kormend,

Matyas kiraly u. 65-

batch releaser,

packager, Egis

Pharmaceuticals PLC,

1165 Budapest,


120-bulk

manufacturer

Hungary R06AE07 15293/125.04.2017

04.02.2021OTC


PLC, 1106 Budapest,


Hungary


dihydrochloride)drops oral

10mg/ml,

20ml glass vial with

dropper


PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary R06AE07 1546902.04.2016

02.04.2021OTC


PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

3331 Patanol

olopatadine

(olopatadine

hydrochloride)

drops eye1mg/ml,

5ml plastic botlle

S.A. Alcon-Couvreur

N.V. (Rijksweg 14,

Puurs, B-2870)

Belgium S01GX09 1300028.10.2013

28.10.2018PoM

S.A. Alcon-Couvreur

N.V. (Rijksweg 14,

Puurs, B-2870,

Belgium)

3332 Pedeks permethrinsolution for external

use

5mg/g,

60ml glass bottle

LMP Ltd., 1, Vietalvas

street, Riga, LV-1009Latvia P03AC04 15169

17.12.2015

17.12.2020OTC

LMP Ltd., 1,

Vietalvas street, Riga,

LV-1009, Latvia

3333 Pedilin permethrin shampoo10.4mg/ml,

100ml plastic bottle

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia P03AC04 1440816.04.2015

16.04.2020OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3334 Pegasyspeginterferon alfa-

2asolution for injection

180mcg/0,5ml, 0,5ml pre-

filled syringe and 1

injection needle

F.Hoffmann-La Roche

Ltd., Wurmisweg,

4303 Kaiseraugst

Switzerland L03AB11 1335504.04.2014

04.04.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

723

3335 PegIntronpeginterferon alfa-

2b

powder lyophilized

for solution for

injection

50mcg/0,5ml,

glass vial (1) and 0,7ml

solvent in ampoule

Schering-Plough Labo

N.V., Industriepark

30 B-2220, Heist-op-

den-Berg - solvent

manufacturer,

secondary packager,

batch releaser;

(Schering-Plough

(Brinny) Company,

Brinny,

Inhanshannon, Co.

Cork,Ireland-bulk

manufacturer,

primary packager)

Belgium

L03AB10;

new

indication

13402/114.04.2014

14.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland


2b

powder lyophilized

for solution for

injection

80mcg/0,5ml,

glass vial (1) and 0,7ml

solvent in ampoule


N.V., Industriepark


den-Berg - solvent

manufacturer,

secondary packager,

batch releaser;

(Schering-Plough

(Brinny) Company,

Brinny,

Inhanshannon, Co.

Cork,Ireland-bulk

manufacturer,

primary packager)

Belgium

L03AB10;

new

indication

13403/114.04.2014

14.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

724


2b

powder lyophilized

for solution for s/c

injection

100mcg/0,5ml, glass vial

(1) and 0,7ml solvent in

ampoule


N.V., Industriepark


den-Berg - solvent

manufacturer,

secondary packager,

batch releaser;

(Schering-Plough

(Brinny) Company,

Brinny,

Inhanshannon, Co.

Cork,Ireland-bulk

manufacturer,

primary packager)

Belgium

L03AB10;

new

indication

13404/114.04.2014

14.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland


2b

powder lyophilized

for solution for

injection


(1) and 0,7ml solvent in

ampoule


N.V., Industriepark


den-Berg - solvent

manufacturer,

secondary packager,

batch releaser;

(Schering-Plough

(Brinny) Company,

Brinny,

Inhanshannon, Co.

Cork,Ireland-bulk

manufacturer,

primary packager)

Belgium

L03AB10;

new

indication

13405/114.04.2014

14.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

725


2b

powder lyophilized

for solution for

injection

80mcg/0,5ml,

glass vial (1) and 0.7ml

solvent in ampoule


N.V., Industriepark


den-Berg- batch

releaser, secondary

packager, Schering-

Plough (Brinny)

Company, Brinny,

Inhanshannon, Co.

Cork, Ireland- bulk

manufacturer,

primary packager,

Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln, Lower

Saxony, 31789,

Germany-solvent

manufacturer

Belgium

L03AB10;

new

indication

15643/124.05.2016

24.05.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland


2b

powder lyophilized

for solution for

injection

50mcg/0.5ml,

glass vial (1) and 0.7ml

solvent in ampoule


N.V., Industriepark


den-Berg- batch

releaser, secondary

packager, Schering-

Plough (Brinny)

Company, Brinny,

Inhanshannon, Co.

Cork, Ireland- bulk

manufacturer,

primary packager,

Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln, Lower

Saxony, 31789,

Germany-solvent

manufacturer

Belgium

L03AB10;

new

indication

15644/124.05.2016

24.05.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

726


2b

powder lyophilized

for solution for

injection


(1) and 0.7ml solvent in

ampoule


N.V., Industriepark


den-Berg- batch

releaser, secondary

packager, Schering-

Plough (Brinny)

Company, Brinny,

Inhanshannon, Co.

Cork, Ireland- bulk

manufacturer,

primary packager,

Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln, Lower

Saxony, 31789,

Germany-solvent

manufacturer

Belgium

L03AB10;

new

indication

15645/124.05.2016

24.05.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland


2b

powder lyophilized

for solution for

injection


(1) and 0.7ml solvent in

ampoule


N.V., Industriepark


den-Berg- batch

releaser, secondary

packager, Schering-

Plough (Brinny)

Company, Brinny,

Inhanshannon, Co.

Cork, Ireland- bulk

manufacturer,

primary packager,

Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln, Lower

Saxony, 31789,

Germany-solvent

manufacturer

Belgium

L03AB10;

new

indication

15646/124.05.2016

24.05.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

727

3343 Pelethrocin Plus diosmin, hesperidin tablets film-coated

450mg+50mg,


60/4x15/)

Help S.A., Pedini


45500

Greece C05CA53 1673305.06.2017

05.06.2022OTC

Help S.A., 10

Valaoritou str., 14452

Metamorphosis,

Attica, Greece

3344

Pen & Strep

suspension for

injection

procaine penicillin,

dihydrostreptomy-

cin

(dihydrostreptomy-

cin sulfate)

suspension for

injection

200mg/ml+ 250mg/ml,

50ml, 100ml glass vial and

50ml, 100ml plastic vial

Norbrook

Laboratories Limited,

Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP

UK

QJ51RC03;

veterinary

drug

12648/227.12.2014

04.07.2018PoM

Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP, UK

3345 Penbex

penicillin G

procaine,

dihydrostreptomy-

cin sulfate,

betamethasone,

chlorphenamine

maleate, procaine

hydrochloride

suspension for

injection

200IU/ml+ 250mg/ml+

0,5mg/ml+

8mg/ml+15mg/ml, 10ml,

50ml, 100ml glass vial

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19

Spain

QJ01RA01;

veterinary

drug

1427326.02.2015

26.02.2020PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

3346

Penicillin G

sodium 1000000IU

powder for

solution for

injection

benzylpenicillin

(benzylpenicillin

sodium)

powder for solution

for injection

1000000 IU,

glass vials (50, 100)

Antibiotice S.A., 1,

Valea Lupului,

707410 lasi

Romania J01CE01 1579820.07.2016

20.07.2021PoM


Valea Lupului,

707410 lasi, Romania

3347 Penicillin-G RS

benzylpenicillin

(benzylpenicillin

sodium)

powder for solution

for injection

1000000IU,

glass vial (50)

Reyoung

Pharmaceutical Co.

Ltd., No 6 Erlangshan

Road, Yiyuan County,

Shandong Province

China J01CE01 1542416.03.2016

16.03.2021PoM

Reyoung

Pharmaceutical Co.


Road, Yiyuan

County, Shandong

Province, China

728

3348 Pen-Strep 20/20

procaine (procaine

benzylpenicillin G),

dihydrostreptomy-

cin

(dihydrostreptomy-

cin sulfate)

suspension for

injection

200000IU/ml+ 200mg/ml,


Norbrook

Laboratories (105

Armagh road, Newry

BT35 6PU)

UK

QJ01RA01

veterinary

drug

1291607.10.2013

07.10.2018PoM

V.M.D. n.v. (Hoge

Mauw 900, B-2370

Arendonk, Belgium)

3349 Penstrep 20/25 Inj.

procaine penicillin

G,

dihydrostreptomy-

cin

(dihydrostreptomy-

cin sulfate),

procaine (procaine

hydrochloride)

suspension for i/m

injection

200mg/ml+ 183,75IU/ml+

20mg/ml,

100ml glass vial

Kepro BV,

Maagdenburgstraat

17, 7421 ZA Deventer-

secondary packager,

batch releaser, Kepro

BV, Forellenweg 16,

4941SJ

Raamsdonksveer, the

Netherlands- bulk

manufacturer,

primary packager

the Netherlands

QJ01RA01;

veterinary

drug

1461703.07.2015

03.07.2020PoM

Kepro BV,

Maagdenburgstra-at

17, 7421 ZA

Deventer, the

Netherlands

3350 Pentalgin

paracetamol,

naproxen, caffeine,

drotaverine

(drotaverine

hydrochloride),

pheniramine

(pheniramine

maleate)

tablets film-coated

325mg+100mg+

50mg+40mg+ 10mg,


24/2x12/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia N02BE71 1705305.10.2017

05.10.2022OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

3351 Pentalgin Plus

paracetamol,

propyphenazone,

caffeine, codeine

(codeine

phosphate),

phenobarbital

tablets

300mg+250mg+

50mg+8mg+ 10mg,

in blister (12)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18

Russia N02BE71 1279114.08.2013

14.08.2018PoM

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18, Russia

729

3352 Pentalgin-ICN

metamizole

(metamizole

sodium),

paracetamol,

caffeine,

phenobarbital,

codeine (codeine

phosphate)

tablets

300mg+300mg+

50mg+10mg+8mg, in

blister (12/1x12/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia N02BB72 14725/102.05.2016

15.07.2020PoM

OTCPharm PJSC,

123317, Moscow,


Russia

3353 Pentatrop

cyclopentolate

(cyclopentolate

hydrochloride)

drops eye

10mg/ml,

5ml plastic vial-dropper

(1, 10)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01FA04 16845

10.07.2017

10.07.2022PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

3354 Pentovit

thiamine (thiamine

chloride),

pyridoxine

(pyridoxine

hydrochloride),

nicotinamide, folic

acid,

cyanocobalamin

tablets coated

10mg+5mg+20mg+0,4mg

+0,05mg,


Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.

Russia A11BA 1337604.04.2014

04.04.2019OTC

Altayvitamini CJSC,

659325, The Altay


Zavodskaya Str.,

Russia

3355 Peo

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

1000mg,

glass vial (1)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi -

secondary packager,

batch releaser

(Laboratorio Reig

Jofre, S.A., Jarama 111

Poligono Industrial,

Toledo, 45007 Toledo,

Spain - bulk

manufacturer,

primary packager)

Georgia J01DD04 1367008.07.2014

08.07.2019PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia

730

3356 Peo with lidocaine

ceftriaxone

(ceftriaxone

sodium)

powder and solvent

for solution for i/m

injection

1000mg,

glass vial and 3,5ml

solvent in ampoule

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi- batch

releaser, secondary

packager,

LABORATORIO

REIG JOFRE, S.A.,

Gran Capitan, 10,

08970 Sant Joan

Despi, Barcelona,

Spain- bulk

manufacturer,

primary packager

Georgia J01DD04 1680822.06.2017

22.06.2022PoM

GM Pharmaceuticals

Ltd, Phonichala 65,


3357 Pepsane-Rguaiazulene,

dimeticonecapsules

4mg+300mg,


Laboratoires Rosa-

Phytopharma, 2

avenue du Traite de

Rome 78401-Chatou-

batch releaser, L.G.V.

Capsules, 20, rue

Louis-Charles Vernin,

77190 Dammarie les

Lys, France-bulk

manufacturer,

Laboratories Mayoly

Spindler, 6 avenue de

lEurope 78400

Chatou, France-

packager

France A02DA 1430219.03.2015

19.03.2020PoM

Laboratoires Rosa-

Phytopharma, 68, rue

Jean-Jacques

Rousseau 75001 Paris,

France

3358 Pepsane-Rguaiazulene,

dimeticonegel oral

0,4mg/g+300mg/g, 10g

sachets (30)

Laboratoires Rosa-

Phytopharma, 2

avenue du Traite de

Rome 78401-Chatou-

batch releaser,

Laboratoires

Pharmatis, Zone

dactivite Est No. 1, BP

60190 Estress Saint

Denis, France-bulk

manufacturer,

packager

France A02DA 14303/116.04.2015

19.03.2020PoM

Laboratoires Rosa-

Phytopharma, 68, rue

Jean-Jacques

Rousseau 75001 Paris,

France

731

3359 Peptomet domperidone tablets film-coated10mg,


Remedica Ltd.,

Limassol Industrial

Estate, Aharnon


Cyprus A03FA03 1242029.04.2013

29.04.2018PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

3360 Percor acetylsalicylic acidtablets gastro-

resistant

75mg,


56/4x14/)

Salutas Pharma

GmbH, Otto-von-

Guricke-Allee 1,

Barleben, Sachsen-

Anhalt, 39179 - batch

releaser

(Balkanpharma-

Dupnitsa AD, 3

Samokovsko Shosse

str., Dupnitsa 2600,

Bulgaria - bulk

manufacturer)

(Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning,

Bavaria, Germany -

packager)

Germany B01AC06 1365008.07.2014

08.07.2019OTC

Sandoz

Pharmaceuticals

d.d.,Verovshkova 57,

1000 Ljubljana,

Slovenia

732

3361 Percor acetylsalicylic acidtablets gastro-

resistant

150mg,


Salutas Pharma

GmbH, Otto-von-

Guricke-Allee 1,

Barleben, Sachsen-

Anhalt, 39179 - batch

releaser

(Balkanpharma-

Dupnitsa AD, 3

Samokovsko Shosse

str., Dupnitsa 2600,

Bulgaria - bulk

manufacturer)

(Dragenopharm

Apotheker Puschl


84529 Tittmoning,

Bavaria, Germany -

packager)

Germany B01AC06 1365108.07.2014

08.07.2019OTC

Sandoz

Pharmaceuticals

d.d.,Verovshkova 57,

1000 Ljubljana,

Slovenia

3362 Pergoverisfollitropin alfa,

lutropin alfa

powder lyophilized

for solution for s/c

injection

150IU+75IU,

glass vial (1, 3, 10) and

1ml solvent in ampoule

(1, 3, 10)

Merck Serono S.p.A.,

Via delle Magnolie

15, Zona Industriale

di Modugno 70026,

Modugno,(Bari) -


form manufacturer,

packager - Merck

Serono S.A,

Succursale d Aubonne

Zone Industrielle de l

Ouriettaz, 1170

Auboone,

Switzerland)

Italy G03GA05 1266404.07.2013

04.07.2018PoM

Merck Serono Europe

Limited, 56 Marsh

Wall, London E14

9TR, UK

733

3363 Peri Dial

glucose anhydrous,

sodium chloride,

sodium lactate,

calcium chloride,

magnesium

chloride

solution for

peritoneal dialysis

22,7mg/ml+ 5,38mg/ml+

4,48mg/ml+ 0,184mg/ml+

0,051mg/ml,

250ml, 500ml, 750ml,

1000ml, 1500ml, 2000ml,

2500ml, 3000ml, 5000ml

plastic packs

PharmaTech CJSC,


str. 111

Republic of

ArmeniaB05D 12820

17.09.2013

17.09.2018PoM

PharmaTech CJSC,



Armenia

3364 Peristalid lactulose syrup

667mg/ml,


20ml measuring cup

Laboratorios Basi -

Industria

Farmaceutica, S.A.,

Parque Industrial

Manuel Lourenco

Ferreira, Lote 15,

Mortagua, 3450-232

Portugal A06AD11 1606117.10.2016

17.10.2021OTC

GM Pharmaceuticals

Ltd, 65,

Phonichala,Tbilisi,

Georgia

3365 Peritol

cyproheptadine

(cyproheptadine

hydrochloride)

tablets4mg,



PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary R06AX02 1610610.11.2016

10.11.2021PoM


PLC, 1106 Budapest,


Hungary

3366 Perjeta pertuzumabconcentrate for


30mg/ml,

14ml glass vial (1)

Roche Diagnostics

GmbH, Sandhofer

Strasse 116, D-68305

Mannheim-batch

releaser, bulk

manufacturer,

primary packager, F.

Hoffmann-La Roche

AG, Betriebsstandort

Kaiseraugst, 4303

Kaiseraugst,

Switzerland-

secondary packager

Germany

L01XC13;

new

indication

14034/119.12.2014

19.12.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse 124

Basel, CH-4070,

Switzerland

734

3367 Perlinganit nitroglycerinconcentrate for


1mg/ml,

10ml ampoules (10)

Aesica

Pharmaceuticals

GmbH, Alfred-Nobel-

Strasse 10, 40789

Monheim - batch


manufacturer - Ever

Pharma Jena GmbH,

Otto-Schott-Strasse

15, 07745

Jena,Thuringia,

Germany)

Germany C01DA02 1238519.04.2013

19.04.2018PoM

UCB Pharma GmbH,

Alfred-Nobel-Strasse

10, 40789 Monheim,

Germany

3368 Permethrin permethrin cream50mg/g,

50g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaP03AC04 14085

16.12.2014

16.12.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3369Permixon 160mg

capsules

extract

lipidosterolic

serenoa repens

capsules160mg,


Pierre Fabre

Medicament

Production, site

Progipharm, Rue du

Lycee, 45500 Gien

FranceG04CX02;

herbal drug17182

30.11.2017

30.11.2022PoM

Pierre Fabre

Medicament, 45,

place Abel Gance,

92100 Boulogne,

France

735

3370 Perota

piperacillin

(piperacillin

sodium),

tazobactam

(tazobactam

sodium)

powder for solution

for infusion

4000mg+500mg, glass

vial (1)

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi- batch

releaser, secondary

packager,

LABORATORIO

REIG JOFRE, S.A.,

Gran Capitan, 10,

08970 Sant Joan

Despi, Barcelona,

Spain- bulk

manufacturer,

primary packager

Georgia J01CR05 1663825.04.2017

25.04.2022PoM

GM Pharmaceuticals

Ltd, Phonichala 65,


3371 Persen Cardiopassiflora incarnata,

crataeguscapsules

200mg+160mg,


Lek d.d., Verovskova

Str. 57, 1526 LjubljanaSlovenia

HN05CM

herbal drug13608

20.06.2014

20.06.2019OTC

Lek d.d., Verovskova

Str. 57, 1526

Ljubljana, Slovenia

3372 Persen Day

valeriana officinalis

extract, melissa

officinalis extract,

mentha piperita

extract

tablets coated35mg+17,5mg+ 17,5mg,


Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana-

bulk manufacturer,

batch releaser, Lek

Pharmaceuticals

d.d.,Trimlini 2D,

Lendava, 9220,

Slovenia-primary and

secondary packager

SloveniaHN05CM;

herbal drug15087/1

07.06.2016

15.12.2020OTC

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

736

3373 Persen Day


extract, melissa


mentha piperita

extract

tablets coated35mg+17,5mg+ 17,5mg,


Lek Pharmaceuticals

d.d.,Trimlini 2D,

Lendava, 9220 -batch

releaser, packager,

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia-bulk

manufacturer

SloveniaN05CM;

heral drug17100

23.10.2017

23.10.2022OTC

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

3374 Persen Night


extract, melissa


mentha piperita

extract

capsules87,5mg+17,5mg+17,5mg;

(20/2x10/) in blister

Lek Pharmaceuticals


57, 1526 Ljubljana

SloveniaHN05CM;

herbal drug14958/1

07.06.2016

23.10.2020OTC

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

3375 Perufen ibuprofen suspension oral

20mg/ml,

200ml glass vial and

measuring device

Laboratorios Basi -

Industria

Farmaceutica, S.A.,

Parque Industrial

Manuel Lourenco

Ferreira, Lote 15,

Mortagua, 3450-232

Portugal M01AE01 1640810.02.2017

10.02.2022OTC

GM Pharmaceuticals

Ltd, 65,

Phonichala,Tbilisi,

Georgia

3376 Petroleum D5petroleum

rectificatumdrops oral (solution) -

P.P.H. Kosmed

Zbigniew Lezanski

Str. Gen.W.Andersa

3, 48-100 Glubczyce

Polandhomeopathic

drug14992/1

29.12.2015

06.11.2020PoM

P.P.H. Kosmed

Zbigniew Lezanski

Str. Gen.W.Andersa

3, 48-100 Glubczyce,

Poland

737

3377Pharmatex vaginal

ovules

benzalkonium

chlorideovules vaginal

18,9mg

(5/1x5/, 10/2x5/)

Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France G02BB 1354723.05.2014

23.05.2019OTC

Laboratoire Innotech

International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

3378Pharmatex vaginal

tablet

myristalkonium

chloridetablets vaginal

20mg,


Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France G02BB 13548/103.07.2015

23.05.2019OTC


International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

3379 Phenazepam phenazepam tablets1mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05BX 15947

30.08.2016

30.08.2021PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3380 Phenobarbital phenobarbital tablets100mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN03AA02 13959

28.10.2014

28.10.2019PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3381 Phenotropil

N-

carbamoylmethyl-4-

phenyl-2-

pyrrolidone

tablets

100mg,


30/3x10/)

Valenta

Pharmaceuticals JSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2

Russia N06BX 1313010.01.2014

10.01.2019PoM

Valenta

Pharmaceuticals JSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2,

Russia

738

3382Phenylin-

Zdorovyephenindione tablets

30mg,


Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine B01AA02 1642706.03.2017

06.03.2022PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

3383 Phescetampiracetam,

cinnarizinecapsules

400mg+25mg,


ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700

Bulgaria N06BX 1230722.03.2013

22.03.2018PoM

ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700, Bulgaria

3384 Phezampiracetam,

cinnarizinecapsules hard

400mg+25mg,


Balkanpharma-

Dupnitsa AD,

str."Samokovsko

Shosse" N3, Dupnitsa

2600

Bulgaria N06BX 1710623.10.2017

23.10.2022PoM

Balkanpharma-

Dupnitsa AD,

(ACTAVIS GROUP),

str."Samokovsko


2600, Bulgaria

3385 Phlebodia 600 diosmin tablets film-coated

600mg,

blister (15/1x15/,

30/2x15/, 60/4x15/)

Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France C05CA03 12259/209.09.2016

07.03.2018OTC


International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

3386 Phlogenzymbromelain, trypsin,

rutin

tablets gastro-

resistant

450U+1440U+ 100mg,


100/5x20/, 200/10x20/),


Mucos Emulsions

GmbH, Miraustrasse

17, D-13509 Berlin

Germany L03AX 1375905.08.2014

05.08.2019OTC

Mucos Pharma

GmbH & Co. KG,

Miraustrasse 17, D-

13509 Berlin,

Germany

739

3387 Phosphalugelaluminium

phosphategel oral

10400mg,

16g stick sachets (6) and

16g sachets (20)

Pharmatis, Z.A Est.

N1, BP 20, 60190

Estrees Saint-Denis

France A02AB03 1593829.08.2016

29.08.2021OTC

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

3388 Phosphogliv

phospholipids

(lipoid S 100),

glycyrrhizinic acid

(glycyrrhizinic acid

trisodium)

powder lyophilized

for solution for i/v

injection

500mg+200mg, 2,5g glass

vials (5), solvent in vials

or 10ml ampoules (5)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A05AX 13200/130.07.2014

10.01.2019PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

3389 Phosphogliv

phospholipids

(lipoid S 80),

sodium

glycyrrhizinate


trisodium salt)

capsules65mg+35mg,


Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18

Russia A05BA 1420706.02.2015

06.02.2020PoM

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18, Russia

3390 Phosphogliv Forte

phospholipids

(lipoid PPL 400),

sodium

glycyrrhizinate


trisodium salt)

capsules400mg+65mg,


Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia A05AX 1676927.06.2017

27.06.2022PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

3391 Physiotens moxonidine tablets film-coated0,2mg,


Abbott Healthcare

SAS, Route de

Belleville, Lieu dit

Maillard, 01400

Chatillon sur

Chalaronne

France C02AC05 1361227.06.2014

27.06.2019PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

740

3392 Physiotens moxonidine tablets film-coated0,4mg,


Abbott Healthcare

SAS, Route de


Maillard, 01400

Chatillon sur

Chalaronne

France C02AC05 1361327.06.2014

27.06.2019PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

3393 Picamilon picamilon tablets20mg,


Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia N06BX 1373624.07.2014

24.07.2019PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

3394 Picamilon picamilon tablets50mg,


Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia N06BX 1373724.07.2014

24.07.2019PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

3395 Pikovit

vitamin A, vitamin

D3, vitamin C,

vitamin B1, vitamin

B2, vitamin B6,

vitamin B12,

vitamin PP, folic

acid, vitamin B5,

calcium phosphate

pastilles

0.35mg+0.08mg+

10mg+0.25mg+

0.3mg+0.3mg

+0.2mg+3mg+

0.04mg+1.2mg+ 43mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch

releaser, KRKA d.d.,

Novo mesto, Ulica

Rada Pusenjaka 10,

Ljutomer, 9240,

Slovenia-bulk

manufacturer,

packager

Slovenia A11B 1619508.12.2016

08.12.2021OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3396 Pikovit

vitamin A, vitamin

D3, vitamin B2,

vitamin B6, vitamin

B1, vitamin B12,

vitamin C, vitamin

PP, D-panthenol

syrup

900IU/5ml+ 100IU/5ml+

1mg/5ml+ 0,6mg/5ml+

1mg/5ml+ 1mcg/5ml+

50mg/5ml+

5mg/5ml+2mg/5ml,


measuring spoon 5ml

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A11B 1625319.12.2016

19.12.2021OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

741

3397 Pikovit D

vitamin A, vitamin

D3, vitamin C,

nicotinamide,

calcium

pantotenate,

vitamin B2, vitamin

B6, vitamin B1,

folic acid, vitamin

B12, calcium,

phosphorus

lozenges

600IU+80IU+

10mg+3mg+

1,20mg+0,3mg+

0,3mg+0,25mg+

0,04mg+0,2mcg+

12,5mg+10mg,

in blisters (30/2x15/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - secondary

packager, batch

releaser (KRKA d.d.,

Novo mesto, Ulica

Rada Pusenjaka 10,

Ljutomer, 9240,

Slovenia - bulk

manufacturer,

primary packager)

Slovenia A11AA03 13662/119.05.2016

08.07.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8

3398 Pikovit Forte

vitamin A, vitamin

D3, vitamin C,

nicotinamide,

vitamin E, calcium

pantotenate,

vitamin B6,

vitaminB2, vitamin

B1, folic acid,

vitamin B12

pastilles

5000IU+400IU+

60mg+20mg+

15mg+10mg+

2mg+1,7mg+

1,5mg+0,4mg+ 6mcg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - secondary

packager, batch

releaser (KRKA d.d.,

Novo mesto, Ulica

Rada Pusenjaka 10,

Ljutomer, 9240,

Slovenia - bulk

manufacturer,

primary packager)

Slovenia A11BA 1370824.07.2014

24.07.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3399 Pimafucin natamycincream for external

use

20mg/g,

30g aluminium tube

Temmler Italia S.r.l.,

Via delle Industrie 2,

20061 Carugate (MI)

Italy D01AA02 1594801.09.2016

01.09.2021PoM

Astellas Pharma

Europe B.V., the

Netherlands

Sylviusweg 62, 2333

BE Leiden

3400 Pimafucin natamycin suppositories vaginal100mg,

(3/1x3/, 6/2x3/)

Temmler Italia S.r.l.,


20061 Carugate (MI)

Italy G01AA02 1602207.10.2016

07.10.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

742

3401 Pimafucin natamycintablets gastro-

resistant

100mg,


Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands A07AA03 16298/117.10.2017

30.12.2021PoM

LEO Pharma A/S,

Industriparken 55,

DK-2750 Ballerup,

Denmark

3402 Pimafucort

natamycin,

neomycin

(neomycin sulfate),

hydrocortisone

(hydrocortisone

micronized)

cream for external

use

10mg/g+3500U/g+10mg/g,

15g aluminium or plastic

tube

Temmler Italia S.r.L.,


20061 Carugate (MI)

Italy D07CA01 14481/106.05.2017

30.04.2020PoM

LEO Pharma A/S,

Industriparken 55,

DK-2750 Ballerup,

Denmark

3403 Pimafucort

natamycin,

neomycin

(neomycin sulfate),

hydrocortisone

(hydrocortisone

micronized)

ointment for

external use

10mg/g+3500U/g+10mg/g,


tube

Temmler Italia S.r.L.,


20061 Carugate (MI)

Italy D07CA01 14482/206.05.2017

30.04.2020PoM

LEO Pharma A/S,

Industriparken 55,

DK-2750 Ballerup,

Denmark

3404 Pipolphen

promethazine

(promethazine

hydrochloride)

solution for i/v and

i/m injection

25mg/ml,

2ml ampoules (10)


PLC, 1165 Budapest,


120

Hungary R06AD02 1562524.05.2016

24.05.2021PoM


PLC, 1106 Budapest,


Hungary

3405 Piracetam piracetam capsules

400mg,


60/6x10/)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus N06BX03 13855/116.05.2016

18.09.2019PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222120, Minsk

region, Belarus

743

3406 Piracetam piracetam solution for injection200mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2 Line,

No6

Republic of

ArmeniaN06BX03 15561

12.05.2016

12.05.2021PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

3407 Piracetam piracetam solution for injection

200mg/ml,

5ml ampoules,


Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus N06BX03 1608810.11.2016

10.11.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,



3408 Piracetam piracetamsolution for i/m and

i/v injection

200mg/ml,

5ml ampoules,


Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia N06BX03 1712616.11.2017

16.11.2022PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

3409 Piracetam-Darnitsa piracetam solution for injection

200mg/ml,

5ml ampoules,


Darnitsa

Pharmaceutical Firm

CJSC, 02093, Kiev,


Ukraine N06BX03 1236109.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

3410 Piralgin

metamizole

(metamizole

sodium), naproxen,

caffeine,

phenobarbital,

codeine

tablets

300mg+100mg+

50mg+10mg+8mg, in

blister (10, 20/2x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus N02BB72 1495315.10.2015

15.10.2020PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

744

3411 Piramil Extra

ramipril,

amlodipine

(amlodipine

besilate)

capsules5mg+10mg,


Lek Pharmaceuticals


57, 1526 Ljubljana-

batch releaser, Zaklad

Farmaceutyczny

Adamed Pharma S.A.,

33 Szkolna Str., 95-

054 Ksawerow,

Poland-bulk

manufacturer,

primary and

secondary packager

Slovenia C09BB07 15030/129.02.2016

02.12.2020PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1526 Ljubljana,

Slovenia

3412 Piramil Extra

ramipril,

amlodipine

(amlodipine

besilate)

capsules10mg+10mg,


Lek Pharmaceuticals


57, 1526 Ljubljana-


Farmaceutyczny

Adamed Pharma S.A.,


054 Ksawerow,

Poland-bulk

manufacturer,

primary and

secondary packager

Slovenia C09BB07 15031/129.02.2016

02.12.2020PoM

Sandoz


Verovskova Str. 57,

1526 Ljubljana,

Slovenia

3413 Piramil Extra

ramipril,

amlodipine

(amlodipine

besilate)

capsules10mg+5mg,


Lek Pharmaceuticals


57, 1526 Ljubljana-


Farmaceutyczny

Adamed Pharma S.A.,


054 Ksawerow,

Poland-bulk

manufacturer,

primary and

secondary packager

Slovenia C09BB07 15032/129.02.2016

02.12.2020PoM

Sandoz


Verovskova Str. 57,

1526 Ljubljana,

Slovenia

745

3414 Piramil Extra

ramipril,

amlodipine

(amlodipine

besilate)

capsules5mg+5mg,


Lek Pharmaceuticals


57, 1526 Ljubljana-


Farmaceutyczny

Adamed Pharma S.A.,


054 Ksawerow,

Poland-bulk

manufacturer,

primary and

secondary packager

Slovenia C09BB07 15033/129.02.2016

02.12.2020PoM

Sandoz


Verovskova Str. 57,

1526 Ljubljana,

Slovenia

3415 Piroxicam-Akri piroxicam capsules20mg,


Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia M01AC01 1441708.04.2015

08.04.2020PoM

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia

3416 Piroxicam-Akri piroxicam capsules10mg,


Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia M01AC01 1441808.04.2015

08.04.2020PoM

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia

3417 Plaquenil

hydroxychloro-

quine

(hydroxychloro-

quine sulfate)



Sanofi-Synthelabo

Ltd., Edgefield

Avenue, Fawdon,

Newcastle Upon

Tyne, Tyne and

Wear, NE3 3TT

UK P01BA02 1552319.04.2016

19.04.2021PoM

Aventis Pharma

Limited, One Onslow

str.,Guildford Surrey

GU1 4YS, UK

746

3418 Plasmo-Tech 10 hydroxyethyl starch solution for infusion

100mg/ml,

50ml, 100ml, 200ml,

250ml, 400ml, 500ml and

1000ml plastic pack

PharmaTech CJSC,


str. 111

Republic of

ArmeniaB05AA07 15885

23.08.2016

23.08.2021PoM

PharmaTech CJSC,



Armenia

3419 Plasmo-Tech 6 hydroxyethyl starch solution for infusion

60mg/ml,

50ml, 100ml, 200ml,

250ml, 400ml, 500ml and

1000ml plastic pack

PharmaTech CJSC,


str. 111

Republic of


24.09.2015

24.09.2020PoM

PharmaTech CJSC,



Armenia

3420Platyphylline-

Darnitsa

platyphylline

(platyphylline

hydrotartrate)


2mg/ml, (10) ampoules

1ml and (10/2x5/)

ampoules 1ml in blister

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13

Ukraine A03AX 1338004.04.2014

04.04.2019PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13,

Ukraine

3421Platyphylline-

Zdorovye

platyphylline

(platyphylline

hydrotartrate)


2mg/ml,

1ml ampoules (10), 1ml


(10/2x5/, 10/1x10/)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine A03AX 1643306.03.2017

06.03.2022PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

3422 PlaviComb ASclopidogrel,

acetylsalicylic acidtablets film-coated

75mg+75mg,


Orion Pharma Ltd.,

Orion House, 153-154

Tejgaon Industrial

Area, Dhaka-1208

BangladeshB01AC04,

B01AC0613673

08.07.2014

08.07.2019PoM

Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208,

Bangladesh

3423 Plavix

clopidogrel

(clopidogrel

hydrosulfate)

tablets film-coated 75mg,


Sanofi Winthrop

Industrie, 1, rue de la

Vierge, Ambares et

Lagrave, 33565

Carbon Blanc cedex

France B01AC04 1691608.08.2017

08.08.2022PoM

Sanofi Pharma Bristol-

Myers Squibb SNC

174 Avenue de

France-F-75013 Paris,

France

747

3424 Plofed 1% propofolemulsion for

injection or infusion

10mg/ml,

20ml glass vial (5)

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw

Poland N01AX10 1553419.04.2016

19.04.2021PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw,

Poland

3425 Pneumovax 23

pneumococcal

polysaccharide

vaccine

solution for injection 25mcg/0,5ml,

0,5ml glass vial

Merck Sharp &

Dohme B.V.

Waarderweg 39,2031

BN Haarlem - batch

releaser, secondary


manufacturer,

primary packager -

Merck Sharp &

Dohme Corp.,

Sumneytown Pike

P.O. Box West Point,

Pennsylvania 19486-

0004, USA)

the Netherlands J07AL 1690808.08.2017

08.08.2022PoM

Merck Sharp &

Dohme Idea AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

3426 Pofol Injection propofolemulsion for i/v

injection

10mg/ml,

20ml ampoules (5)

DongKook

Pharmaceutical Co.,


ri, Gwanghyewon-


Choongcheongbuk-do

Korea Sourth N01AX10 1260321.06.2013

21.06.2018PoM

DongKook

Pharmaceutical Co.,


ri, Gwanghyewon-

myeon, Jincheon-

gun,

Choongcheongbuk-

do, Korea

3427 Pofol Injection I.V. propofolemulsion for i/v

injection

10mg/ml,

50ml glass vial (1)

Dongkook

Pharmaceutical Co.,

Ltd., 33-19, Yongso 2-

gil, Gwanghyewon-


Chungcheongbuk-do

Korea South N01AX10 1615223.11.2016

23.11.2021PoM

Dongkook

Pharmaceutical Co.,

Ltd., 7, Teheran-ro

108-gil, Gangnam-gu,

Seoul, Korea South

748

3428 Polcortolon triamcinolone tablets4mg,


Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice

Poland H02AB08 1425520.02.2015

20.02.2020PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.



3429 Polcortolon TC

tetracycline

(tetracycline

hydrochloride),

triamcinolone

(triamcinolone

acetonide)

aerosol for external

use (suspension)

23,12mg/g+ 0,58mg/g,

17,3g aluminium

container

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,

2,A. Fleminga str.,03-

176 Warsaw

Poland D07CB01 12595/115.09.2017

21.06.2018PoM

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,


176 Warsaw, Poland

3430 Polio Sabinpoliovirus types 1,

poliovirus types 3suspension oral

not less than-

106CCID50/dose+not less

than-105.8CCID50/ dose,

1ml glass vials (10dose)

(100)

GlaxoSmithKline

Biologicals s.a., Rue

de l' Institut, 89 B-

1330 Rixensart-batch

releaser (bulk

manufacturer,

packager-

GlaxoSmithKline

Biologicals SA, Parc

de la Noire Epine Rue

Fleming, 20 1300

Wavre, Belgium)

BelgiumJ07BF04;

vaccine15830

20.07.2016

20.07.2021PoM

GlaxoSmithKline



1330 Rixensart,

Belgium

3431 Polio Sabinpoliovirus types 1,

poliovirus types 3suspension oral

not less than-

106CCID50/dose+not less

than-105.8CCID50/ dose,

2ml glass vials (20dose)

(100)

GlaxoSmithKline




releaser (bulk

manufacturer,

packager-

GlaxoSmithKline



Fleming, 20 1300

Wavre, Belgium)

BelgiumJ07BF04;

vaccine15831

20.07.2016

20.07.2021PoM

GlaxoSmithKline



1330 Rixensart,

Belgium

749

3432 Pollenna

Allium cepa,

Euphrasia

officinalis, Sabadilla

officinarum

tablets6C+6C+6C,


A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH

UK

S01GX

homeopathic

drug

1351830.05.2014

30.05.2019PoM

A Nelson and Co


Way, Wimbledon,

London SW19 8UH,

UK

3433 Pollezin

levocetirizine

(levocetirizine

dihydrochloride)

tablets film-coated

5mg,

in blister (7/1x7/, 14/2x7/,

10/1x10/, 20/2x10/,

30/3x10/)


PLC, 9900, Kormend,

Matyas kiraly st. 65

Hungary R06AE09 13524/122.06.2015

30.05.2019OTC


PLC, 1106 Budapest,


Hungary

3434 Pollezin

levocetirizine

(levocetirizine

dihydrochloride)

drops oral5mg/ml,

20ml glass vial


PLC, 9900, Kormend,


Hungary R06AE09 13525/114.04.2015

30.05.2019OTC


PLC, 1106 Budapest,


Hungary

3435 Pollodoxin

doxycycline

(doxycycline

hyclate)

solution oral100mg/ml, 1000ml plastic

bottle

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19

Spain

QA01AB22

veterinary

drug

1230322.03.2013

22.03.2018PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

3436 Polmatine

memantine

(memantine

hydrochloride)

solution oral

5mg/dose (0.5ml), 50ml

and 100ml glass bottle

and pump dispenser

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10 - batch

releaser, Medana

Pharma JSC, str.

Polskiej Organizacji

Wojskowej 57, 98-200

Sieradz, Poland-bulk

manufacturer,

packager

Poland N06DX01 1601006.10.2016

06.10.2021PoM

Pharmaceutical

Works Polpharma

S.A.,19 Pelplinska

Str., 83-200 Starogard

Gdanski, Poland

750

3437 Polmatine

memantine

(memantine

hydrochloride)

tablets film-coated

10mg,


56/4x14/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland N06DX01 1666911.05.2017

11.05.2022PoM

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

3438 Polmatine

memantine

(memantine

hydrochloride)

tablets film-coated

20mg,


56/4x14/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland N06DX01 1667011.05.2017

11.05.2022PoM

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

3439 Polvertic

betahistine

(betahistine

dihydrochloride)

tablets

24mg,


30/3x10/, 40/4x10/,

50/5x10/, 60/6x10/,

100/10x10/)

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10 - batch

releaser, Catalent

Germany Schorndorf

GmbH,

Steinbeisstrasse 1und

2, 73614, Schorndorf,

Germany-bulk

manufacturer,

Medana Pharma JSC,

str. Polskiej

Organizacji


Sieradz, Poland-

packager

Poland N07CA01 1572422.06.2016

22.06.2021PoM

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

751

3440 Polvertic

betahistine

(betahistine

dihydrochloride)

tablets

16mg,


30/3x10/, 40/4x10/,

50/5x10/, 60/6x10/,

100/10x10/)

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10 - batch

releaser, Catalent

Germany Schorndorf

GmbH,



Germany-bulk

manufacturer,

Medana Pharma JSC,

str. Polskiej

Organizacji


Sieradz, Poland-

packager

Poland N07CA01 1572522.06.2016

22.06.2021PoM

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

3441 Polvertic

betahistine

(betahistine

dihydrochloride)

tablets

8mg,


30/3x10/, 40/4x10/,

50/5x10/, 60/6x10/,

100/10x10/)

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10 - batch

releaser, Catalent

Germany Schorndorf

GmbH,



Germany-bulk

manufacturer,

Medana Pharma JSC,

str. Polskiej

Organizacji


Sieradz, Poland-

packager

Poland N07CA01 1572622.06.2016

22.06.2021PoM

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

752

3442 Polydexa

neomycin

(neomycin sulfate),

polymyxin B

(polymyxin B

sulfate),

dexamethasone

(dexamethasone

sodium

metasulphoben-

zoate)

drops ear (solution)

1g(650000U) /100ml+

1000000U/100ml+0,1g/10

0ml,

10,5ml bottle-dropper


Recordati, 68 Rue

Marjolin 92300

Levallois-Perret -

batch releaser

(Pharmaster, Zone

Industrielle de Krafft,

67150 Erstein, France -

bulk manufacturer,

packager)

France S02CA06 14593/113.09.2016

08.06.2020PoM

Laboratoires

Bouchara-Recordati,

68 Rue Marjolin

92300 Levallois-

Perret, France

3443 Polydexa

neomycin

(neomycin sulfate),

polymyxin B

(polymyxin B

sulfate),

dexamethasone

(dexamethasone

sodium

metasulfobenzoate)

drops ear

1g

(650000U)/100ml+100000

0U/100ml+0,1g/100ml,

10,5ml bottle-dropper


Recordati, Immeuble

"le Wilson", 70

avenue du General de

Gaulle, 92800

Puteaux- batch

releaser, Pharmaster,

Zone Industrielle de

Krafft, 67150 Erstein,

France- bulk

manufacturer,

packager

France S02CA06 1659810.04.2017

10.04.2022PoM

Laboratoires

Bouchara-Recordati,

Immeuble "le

Wilson", 70 avenue

du General de Gaulle,

92800 Puteaux,

France

3444Polydexa with

phenylephrine

neomycin

(neomycin sulfate),

polymyxin B

(polymyxin B

sulfate),

dexamethasone

(dexamethasone

metasulfobenzoate

sodium),

phenylephrine

(phenylephrine

hydrochloride)

spray nasal

6500IU/ml+ 10000IU/ml+

0,25mg/ml+ 2,5mg/ml,


Laboratoires

SOPHARTEX, 21 Rue

du Pressoir, 28500

VERNOUILLET

FranceS02CA06,

R01AD5313655

08.07.2014

08.07.2019PoM

Laboratoires

Bouchara-Recordati,

Immeuble le Wilson,

70 Avenue du

General de Gaulle,

92800 Puteaux,

France

753

3445Polyglucin-

PharmaTechdextran 70 solution for infusion

60mg/ml,

100ml, 200ml, 250ml,


PharmaTech CJSC,


str. 111

Republic of


15.12.2015

15.12.2020PoM

PharmaTech CJSC,



Armenia

3446 Polygynax

neomycin sulfate,

polymyxin B

sulfate, nystatin

capsules vaginal

(35000IU+35000IU+10000

0IU)

(6/1x6/, 12/2x6/)

Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France G01AA51 1355023.05.2014

23.05.2019PoM


International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

3447 Polyoxidonium azoximer bromide

lyophilized powder

for solution for

injection and topical

use

6mg,

glass vials (5), glass vials in

blister (5/1x5/)

NPO Petrovax Pharm

LLC, 1 Sosnovaya str.,

Pokrov village,

Podolsk district,

Moscow region,

142143, Russia

Russia L03 1342814.04.2014

14.04.2019PoM

NPO Petrovax Pharm


Pokrov village,

Podolsk district,

Moscow region,

142143, Russia

3448 Polyoxidonium azoximer bromidesuppositories rectal

and vaginal

6mg

(10/2x5/)

NPO Petrovax Pharm


Pokrov village,

Podolsk district,

Moscow region,

142143 - secondary

packager, batch

releaser; (NPO

Petrovax Pharm LLC,

korp. 4, 10

Zagorievskaya str.,

Moscow, 115598,

Russia - bulk

manufacturer,

primary packager)

Russia L03 1342914.04.2014

14.04.2019OTC

NPO Petrovax Pharm


Pokrov village,

Podolsk district,

Moscow region,

142143, Russia

754

3449 Polyoxidonium azoximer bromidesuppositories vaginal

and rectal

12mg

(10/2x5/)

NPO Petrovax Pharm


Pokrov village,

Podolsk district,

Moscow region,

142143 - secondary

packager, batch

releaser; (NPO

Petrovax Pharm LLC,

korp. 4, 10

Zagorievskaya str.,

Moscow, 115598,

Russia - bulk

manufacturer,

primary packager)

Russia L03 1343014.04.2014

14.04.2019OTC

NPO Petrovax Pharm


Pokrov village,

Podolsk district,

Moscow region,

142143, Russia

3450 Polyoxidonium azoximer bromide tablets12mg,


NPO Petrovax Pharm


Pokrov village,

Podolsk district,

Moscow region,

142143 - secondary

packager, batch

releaser; (NPO

Petrovax Pharm LLC,

korp. 4, 10

Zagorievskaya str.,

Moscow, 115598,

Russia - bulk

manufacturer,

primary packager)

Russia L03 1343114.04.2014

14.04.2019OTC

NPO Petrovax Pharm


Pokrov village,

Podolsk district,

Moscow region,

142143, Russia

3451 Postinor levonorgestrel tablets0,75mg,

in blister (2/1x2/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AC03 1445304.05.2015

04.05.2020OTC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

755

3452 Potassium Orotate potassium orotate tablets

500mg,

in blister (10/1x10/),

in strip (10/1x10/)

PJSC 'Lubnypharm',

37500, Poltava obl.,

Lubny, Petrovskogo

str. 16

Ukraine A14B 1387906.10.2014

06.10.2019OTC

PJSC 'Lubnypharm',

37500, Poltava obl.,

Lubny, Petrovskogo

str. 16, Ukraine

3453 Povidone-iodine povidone-iodine ointment10mg/ml,

20g aluminium tube

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus D08AG02 1402426.11.2014

26.11.2019OTC

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

3454 Povidone-iodine povidone-iodine suppositories vaginal200mg,

(14/2x7/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G01AX11 1583520.07.2016

20.07.2021OTC

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

3455 Prabegin pregabalin capsules

150mg,


28/2x14/, 56/4x14/)

Nobelfarma Ilac

Sanayii Ve Tic. A.S.

81100 Sancaklar,

Duzce

Turkey N03AX16 1332517.03.2014

17.03.2019PoM/UC


PLC, 1106 Budapest,


Hungary


75mg,


28/2x14/, 56/4x14/)

Nobelfarma Ilac


81100 Sancaklar,

Duzce

Turkey N03AX16 1332617.03.2014

17.03.2019PoM/UC


PLC, 1106 Budapest,


Hungary


25mg,


28/2x14/, 56/4x14/)

Nobelfarma Ilac


81100 Sancaklar,

Duzce

Turkey N03AX16 1332717.03.2014

17.03.2019PoM/UC


PLC, 1106 Budapest,


Hungary

756


50mg,


28/2x14/, 56/4x14/)

Nobelfarma Ilac


81100 Sancaklar,

Duzce

Turkey N03AX16 1332817.03.2014

17.03.2019PoM/UC


PLC, 1106 Budapest,


Hungary


300mg,


28/2x14/, 56/4x14/)

Nobelfarma Ilac


81100 Sancaklar,

Duzce

Turkey N03AX16 1332917.03.2014

17.03.2019PoM/UC


PLC, 1106 Budapest,


Hungary

3460 Predizin

trimetazidine

(trimetazidine

dihydrochloride)

tablets prolonged-

release film-coated

35mg,


Gedeon Richter

Poland Sp.z o.o., ul.


5 , Grodzisk

Mazowiecki, 05-825 -

batch releaser Gedeon

Richter Poland Sp.z

o.o., ul.Graniczna 35,


05-825, Poland- bulk

manufacturer,

packager)

Poland C01EB15 1445704.05.2015

04.05.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3461 Prednisolone prednisolone solution for injection30mg/ml,

1ml ampoules (3)

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9

Ukraine H02AB06 1222807.03.2013

07.03.2018PoM

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9,

Ukraine

3462 Prednisolone prednisoloneointment for

external use

5mg/g,

10g aluminium tube

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30)

Belarus D07AA03 1289707.10.2013

07.10.2018PoM

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30,

Belarus)

757

3463 Prednisolone prednisoloneointment for

external use

5mg/g,

10g aluminium tube

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus D07AA03 1389206.10.2014

06.10.2019PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

3464 Prednisolone

prednisolone

(prednisolone

sodium phosphate)


30mg/ml,


(5/1x5)

"BIOFARMA" "PP"



Kyiv region

Ukraine H02AB06 1626319.12.2016

19.12.2021PoM

"BIOFARMA" "PP"



Kyiv region, Ukraine

3465Prednisolone 5mg

Tabletsprednisolone tablets

5mg,


CP Pharmaceuticals

Ltd., Ash Road North,

Wrexham LL 13 9UF -


form manufacturer,

packager - Wockhardt

Limited, Survey No.

106/4-5-7, Kadaiya,

Nani Daman, IN-

396210, India)

UK H02AB06 1263021.06.2013

21.06.2018PoM

Wockhardt UK

Limited, Ash Road

North, Wrexham

Industrial Estate, LL

13 9 UF, UK

3466Prednisolone-

Belmedprednisolone tablets

5mg,

in blister

(10, 50/5x10/)

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30)

Belarus H02AB06 1289607.10.2013

07.10.2018PoM

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30,

Belarus)

758

3467 Prednison-Pabi prednisone tablets

5mg,

in blister (100/5x20/) and


Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice

Poland H02AB07 1641910.02.2017

10.02.2022PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.



3468 Preductal MR

trimetazidine

(trimetazidine

dihydrochloride)

tablets film-coated

modified-release

35mg,


Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C01EB15 1649417.03.2017

17.03.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

3469 Preductrim MR

trimetazidine

(trimetazidine

dihydrochloride)

tablets prolonged-

release film-coated

35mg,


Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208

Bangladesh C01EB15 1326224.02.2014

24.02.2019PoM

Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208,

Bangladesh

3470 Prefetal

beta carotene,

vitamin B1, vitamin

B2, vitamin B6,

vitamin B12, vitamin

C, vitamin D3,

vitamin E, folic acid,

biotin, nicotinamide,

chromium

(chromium chloride),

copper (copper

sulfate), iron (ferrous

fumarate), iodine

(potassium iodide),

molybdenum (sodium

molybdate dihydrate),

selenium (sodium

selenite), zinc (zinc

oxide), magnesium,

calcium

tablets film-coated

2mg+1.4mg+

1.4mg+1.9mg+

2.6mcg+85mg+ 200IU

(5mcg)+15mg+

600mcg+30mcg+

18mg+30mcg+

1mg+27mg+

200mcg+50mcg+

60mcg+11mg+

53mg+150mg,

in glass bottle (30)

Ginsana SA,Via

Mulini, 6934 BioggioSwitzerland A11AA03 15849

20.07.2016

20.07.2021OTC

Ginsana SA,Via

Mulini, 6934 Bioggio,

Switzerland

759

3471 Pregabalin Canon pregabalin capsules

75mg,


14/1x14/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N03AX16 1510115.12.2015

15.12.2020PoM/UC

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia


150mg,


14/1x14/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N03AX16 1510215.12.2015

15.12.2020PoM/UC

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia


300mg,


14/1x14/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N03AX16 1510315.12.2015

15.12.2020PoM/UC

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

3474 Pregabalin-Richter pregabalin capsules

75mg,


56/4x14)

Gedeon Richter-RUS

JSC, Lesnaya st. 40,

Shuvoye, Moscow

region, Yegoriyevsky

district, 140342

Russia N03AX16 15104/102.08.2016

15.12.2020PoM/UC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary


150mg,


56/4x14/)

Gedeon Richter-RUS


Shuvoye, Moscow


district, 140342

Russia N03AX16 15105/102.08.2016

15.12.2020PoM/UC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

760


300mg,


56/4x14/)

Gedeon Richter-RUS


Shuvoye, Moscow


district, 140342

Russia N03AX16 15106/102.08.2016

15.12.2020PoM/UC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3477 Pregnavit

vitamin A , vitamin

D3, vitamin E,

vitamin B1 ,

vitamin B2, vitamin

B6, vitamin B12,

vitaminPP,

VitaminC, calcium

pantotenat ,

calcium lactate,

folic acid, ferrum

(ferrum fumarate),

calcium (calcium

hydrogenphosphate

anhydrous)

capsules

3000IU+200IU+

10mg+1,5mg+

2,5mg+5mg+

5mcg+15mg+

75mg+10mg+

6,51mg+0,75mg+

30mg+250mg,


60/6x10/)

Merckle GmbH,

Ludwig-Merckle-

Strasse 3, 89143

Blaubeuren -

packager, batch


manufacturer - R.P.

Scherer GmbH & Co.

KG, Gammelsbacher

str. 2, 69412

Eberbach, Germany)

Germany A11AA04 1279414.08.2013

14.08.2018OTC

Ratiopharm

GmbH,Graf-Arco-

Strasse 3, 89079 Ulm,

Germany

3478 Pregnylgonadotrophin

chorionic

powder lyophilized


and s/c injection

1500IU,

2ml ampoules (3) and

1ml solvent in ampoules

(3)

N.V. Organon,


CC OSS, the

Netherlands (legal

address -N.V.

Organon,


AB Oss, the

Netherlands)

the Netherlands G03GA01 1475703.08.2015

03.08.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

3479 Pregnylgonadotrophin

chorionic

powder lyophilized


and s/c injection

5000IU,

ampoule 2ml and 1ml

solvent in ampoule

N.V. Organon,


CC OSS, the

Netherlands (legal

address -N.V.

Organon,


AB Oss, the

Netherlands)


03.08.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

761

3480 Prenessa

perindopril

(perindopril

erbumine)

tablets4mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09AA04 1521730.12.2015

30.12.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3481 Prenessa

perindopril

(perindopril

erbumine)

tablets8mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09AA04 1521830.12.2015

30.12.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3482Prestance

10mg/10mg

perindopril

(perindopril

arginine),

amlodipine

(amlodipine

besilate)

tablets10mg+10mg,


Servier (Ireland)

Industries Ltd, Gorey

Road, Arklow-Co

Wicklow

Ireland C09BB04 1323524.02.2014

24.02.2019PoM

Les Laboratoires

Servier, 50, Rue

Carnot 92284

Suresnes cedex,

France

3483Prestance

10mg/5mg

perindopril

(perindopril

arginine),

amlodipine

(amlodipine

besilate)

tablets10mg+5mg,

plastic container (30)

Servier (Ireland)


Road, Arklow-Co

Wicklow

Ireland C09BB04 1323424.02.2014

24.02.2019PoM

Les Laboratoires

Servier, 50, Rue

Carnot 92284

Suresnes cedex,

France

3484Prestance

5mg/10mg

perindopril

(perindopril

arginine),

amlodipine

(amlodipine

besilate)

tablets5mg+10mg,


Servier (Ireland)


Road, Arklow-Co

Wicklow

Ireland C09BB04 1323324.02.2014

24.02.2019PoM

Les Laboratoires

Servier, 50, Rue

Carnot 92284

Suresnes cedex,

France

3485Prestance

5mg/5mg

perindopril

(perindopril

arginine),

amlodipine

(amlodipine

besilate)

tablets5mg+5mg,


Servier (Ireland)


Road, Arklow-Co

Wicklow

Ireland C09BB04 1323224.02.2014

24.02.2019PoM

Les Laboratoires

Servier, 50, Rue

Carnot 92284

Suresnes cedex,

France

762

3486 Prestarium 10mg

perindopril

(perindopril

arginine)



Les Laboratoires



Gidy

France C09AA04 1681122.06.2017

22.06.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

3487 Prestarium 5mg

perindopril

(perindopril

arginine)



Les Laboratoires



Gidy

France C09AA04 1681222.06.2017

22.06.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

3488Prestarium Combi

Arginine

perindopril

(perindopril

arginine),

indapamide

tablets film-coated5mg+1,25mg,


Servier (Ireland)


Road,Arklow-Co

Wicklow

Ireland C09BA04 1257906.06.2013

06.06.2018PoM

Les Laboratoires

Servier, 50, Rue

Carnot 92284

Suresnes cedex,

France

3489Prestarium COMBI

Arginine

perindopril

(perindopril

arginine),

indapamide



Les Laboratoires



Gidy

France C09BA04 1716830.11.2017

30.11.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

3490Prestilol

10mg/10mg

bisoprolol

(bisoprolol

fumarate),

perindopril

(perindopril

arginine)



Les Laboratoires



Gidy

France C09BX02 1616123.11.2016

23.11.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

3491 Prestilol 10mg/5mg

bisoprolol

(bisoprolol

fumarate),

perindopril

(perindopril

arginine)



Les Laboratoires



Gidy

France C09BX02 1616223.11.2016

23.11.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

763


bisoprolol

(bisoprolol

fumarate),

perindopril

(perindopril

arginine)



Les Laboratoires



Gidy

France C09BX02 1616323.11.2016

23.11.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France


bisoprolol

(bisoprolol

fumarate),

perindopril

(perindopril

arginine)



Les Laboratoires



Gidy

France C09BX02 1616423.11.2016

23.11.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

3494 Prevenar 13

pneumococcal

polysaccharide conjugate

vaccine (pneumococcal

polysaccharide serotype 1,

pneumococcal


pneumococcal


pneumococcal


pneumococcal

polysaccharide serotype 6A,

pneumococcal

polysaccharide serotype 6B,

pneumococcal

polysaccharide serotype 7F,

pneumococcal

polysaccharide serotype 9V,

pneumococcal


pneumococcal

polysaccharide serotype

18C, pneumococcal


19A, pneumococcal


19F, pneumococcal


23F)

suspension for

injection

2.2mcg/1dose+

2.2mcg/1dose+

2.2mcg/1dose+

2.2mcg/1dose+

2.2mcg/1dose+

4.4mcg/1dose+

2.2mcg/1dose+

2.2mcg/1dose+

2.2mcg/1dose+

2.2mcg/1dose+

2.2mcg/1dose+

2.2mcg/1dose+

2.2mcg/1dose,

0.5ml/1dose pre-filled

syringe (1, 10) and needle

Wyeth

Pharmaceuticals, New

Lane, Havant,

Hampshire PO9 2NG -

batch releaser,

secondary packager,

Pfizer Ireland

Pharmaceuticals,

Grange Castle

Business Park,

Clondalkin, Dublin

22, Ireland-bulk

manufacturer,

primary packager

UKJ07AL02;

vaccine15438

02.04.2016

02.04.2021PoM

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13

9NJ, UK

764

3495 Prezista

darunavir

(darunavir

ethanolate)



Janssen-Cilag S.p.A.,

Via C. Janssen, 04100

Borgo San Michele,

Latina-packager,


manufacturer-Janssen-

Ortho LLC, State

Road 933 km 0,1

Marney Ward,

Gurabo, Puerto Rico,

USA)

Italy J05AE10 1582120.07.2016

20.07.2021PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

3496 Prezista

darunavir

(darunavir

ethanolate)





Borgo San Michele,

Latina-packager,


manufacturer-Janssen-

Ortho LLC, State

Road 933 km 0,1

Marney Ward,

Gurabo, Puerto Rico,

USA)

Italy J05AE10 1582220.07.2016

20.07.2021PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

3497Prilamid

2mg/0,625mg

perindopril

(perindopril tert-

butylamine),

indapamide

tablets

2mg+0,625mg,


30/3x10/, 50/5x10/,

60/6x10/)

Lek Pharmaceuticals


57, 1526 Ljubljana-

bulk manufacturer,

batch releaser, Lek

Pharmaceuticals

d.d.,Trimlini 2D,

Lendava, 9220,


secondary packager

Slovenia C09BA04 1554119.04.2016

19.04.2021PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

765

3498Prilamid

4mg/1,25mg

perindopril

(perindopril tert-

butylamine),

indapamide

tablets

4mg+1,25mg,


30/3x10/, 50/5x10/,

60/6x10/)

Lek Pharmaceuticals


57, 1526 Ljubljana-

bulk manufacturer,

batch releaser, Lek

Pharmaceuticals

d.d.,Trimlini 2D,

Lendava, 9220,


secondary packager

Slovenia C09BA04 1554019.04.2016

19.04.2021PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

3499 Priligy

dapoxetine

(dapoxetine

hydrochloride)


in blister (3/1x3/, 6/1x6/)

Menarini-Von

Heyden GmbH,

Leipziger Strasse 7-13,

01097 Dresden

Germany G04BX14 1429019.03.2015

19.03.2020PoM

Berlin-Chemie AG

(Menarini Group),

Glienicker Weg 125,

12489 Berlin,

Germany

3500 Priligy

dapoxetine

(dapoxetine

hydrochloride)



Menarini-Von

Heyden GmbH,


01097 Dresden

Germany G04BX14 1429119.03.2015

19.03.2020PoM

Berlin-Chemie AG

(Menarini Group),

Glienicker Weg 125,

12489 Berlin,

Germany

3501 Primacefcefepime (cefepime

hydrochloride)

powder for solution

for injection

1000mg,

glass vial

Aversi-Rational Ltd,

0198 Tbilisi,

Chirnakhuli str. 14 -

secondary packager,


form manufacturer,

primary packager -

North China

Pharmaceutical Co.,

Ltd.,Shijiazhuang City

and No 108, Haihe

Road, High & New

Technology

Development Zone,

Shijiazuang City,

China)

Georgia J01DE01 1331204.03.2014

04.03.2019PoM


0198 Tbilisi,

Chirnakhuli str. 14,

Georgia

766

3502 Primacef-Aversicefepime (cefepime

hydrochloride)

powder for solution

for injection

1000mg,

glass vial (1) and (50)



0198 Tbilisi-

secondary packager,

batch releaser-

(Reyoung

Pharmaceutical Co.


Road, Yiyuan County,

Shandong Province,

China - bulk

manufacturer,

primary packager)

Georgia J01DE01 16525/226.12.2017

17.03.2022PoM




3503 Primafungin natamycin cream20mg/g,

30g aluminium tube

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

Moldova D01AA02 12400/130.08.2013

19.04.2018PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

3504 Primafungin natamycin suppositories vaginal100mg

(3/1x3/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G01AA02 1346406.05.2014

06.05.2019PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

767

3505 Priorix

live attenuated

measles

virus(Schwarz

strain), live

attenuated mumps

virus(RIT 4385

strain), live

attenuated rubella

virus(Wistar RA

27/3 strain)

powder lyophilized

and solvent for


not less than

103.0CCID50/dose+not

less than


less than

103.0CCID50/dose; glass

vial/dose and 0.5ml

solvent in ampoule

GlaxoSmithKline


de l Institut, 89 B-

1330 Rixensart- batch

releaser, Corixa

Corporation, 325

North Bridge Street,

Marietta,

Pennsylvania (PA)

17547, USA-bulk

manufacturer,

primary packager,

CRNA SA, Zoning

Industriel d

Heppignies Ouest,

Avenue d Heppignies,

Fleurus, 6220,

Belgium-secondary

packager

BelgiumJ07BD52;

vaccine15671

08.06.2016

08.06.2021PoM

GlaxoSmithKline



1330 Rixensart,

Belgium

3506 Priorix

live attenuated

measles

virus(Schwarz

strain), live

attenuated mumps

virus(RIT 4385

strain), live

attenuated rubella

virus(Wistar RA

27/3 strain)

powder lyophilized

and solvent for


not less than


less than


less than

103.0CCID50/dose; glass

vial/dose and 0.5ml

solvent in ampoule

GlaxoSmithKline



1330 Rixensart- batch

releaser, Fidia

Farmaceutici S.P.A.,

Via Ponte Della

Fabbrica 3/A-35031

Abano Terme (PD),

Italy-bulk

manufacturer,

primary packager,

CRNA SA, Zoning

Industriel d

Heppignies Ouest,

Avenue d Heppignies,

Fleurus, 6220,

Belgium-secondary

packager

BelgiumJ07BD52;

vaccine15672

08.06.2016

08.06.2021PoM

GlaxoSmithKline



1330 Rixensart,

Belgium

768

3507 Privigenhuman normal

immunoglobulinsolution for infusion

100mg/ml,

25ml glass vial

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22

Switzerland J06BA02 1610710.11.2016

10.11.2021PoM

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22,

Switzerland



100mg/ml,

50ml glass vial

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22


10.11.2021PoM

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22,

Switzerland



100mg/ml,

200ml glass vial

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22


10.11.2021PoM

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22,

Switzerland



100mg/ml,

100ml glass vial

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22


10.11.2021PoM

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22,

Switzerland

3511 Procto-Glyvenoltribenoside,

lidocainesuppositories rectal 400mg+40mg, (10/2x5/)

Delpharm Huningue

S.A.S., 26 rue de la

Chapelle, 68330

Huningue

France C05AX03 1301225.11.2013

25.11.2018OTC

Novartis Consumer

Health SA, Route de I

Etraz, 1260 Nyon,

Switzerland

3512 Proctomed

phenylephrine

(phenylephrine

hydrochloride),

cinchocaine, shark

liver oil

cream rectal

2.5mg/g+10mg/g+

30mg/g,

20g aluminum tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC05AX03 12628

21.06.2013

21.06.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Armenia

769

3513 Proculin

naphazoline

(naphazoline

hydrochloride)

drops eye0,3mg/ml,

10ml plastic vial

Alkaloid AD-Skopje

bul. Aleksandar

Makedonski 12, 1000

Skopje - batch


manufacturer,

packager Mefar Ilac

Sanayi A.S.,

Ramazanoglu, Mah.

Ensar.Cad.20 Kurtkoy-

Pendik, TR-34906

Istanbul, Turkey)

Macedonia SO1GA01 1215901.02.2013

01.02.2018OTC

Alkaloid AD-Skopje

bul. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

3514 PROGEPTINornithine (ornithine

aspartate)

concentrate for


500mg/ml,


"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,

village Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia A05BA06 1654303.04.2017

03.04.2022PoM

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

3515 Prograf tacrolimus capsules0,5mg,


Astellas Ireland Co.

Ltd., Killorglin,

County Kerry

Ireland L04AD02 1595002.09.2016

02.09.2021PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, The

Netherlands

3516 Prograf tacrolimus capsules5mg,



Ltd., Killorglin,

County Kerry

Ireland L04AD02 1595102.09.2016

02.09.2021PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, The

Netherlands

770

3517 Prograf tacrolimus capsules1mg,



Ltd., Killorglin,

County Kerry

Ireland L04AD02 1595202.09.2016

02.09.2021PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, The

Netherlands

3518 Prograf tacrolimus

concentrate for

solution for i/v

injection

5mg/ml,

2ml ampoules (1ml

concentrate) (10)


Ltd., Killorglin,

County Kerry

Ireland L04AD02 1602307.10.2016

07.10.2021PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, The

Netherlands

3519 Prolia denosumabsolution for s/c

injection

60mg/ml,

1ml pre-filled syringe

Amgen Europe B.V.,

Minervum 7061,

Breda, 4817ZK- batch

releaser, packager,

Amgen

Manufacturing

Limited, State Road

31, Km 24.6, Juncos,

Puerto Rico, 00777-

4060, USA-bulk

manufacturer

the Netherlands M05BX04 1630130.12.2016

30.12.2021PoM

Amgen Europe B.V.,

Minervum 7061,

Breda, 4817ZK, the

Netherlands

3520 Promectine ivermectin solution for injection

10mg/ml,

50ml, 100ml plastic

container

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19

Spain

QP54AA01

veterinary

drug

1300314.11.2013

14.11.2018PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

3521 Promectine ivermectin solution oral10mg/ml,


Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19

Spain

QP54AA01;

veterinary

drug

1421203.02.2015

03.02.2020PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

771

3522 Promedolstrimeperidini

hydrochloridum

solution for i/v, i/m

and s/c injection

20mg/ml,

1ml ampoules in blister

(10/2x5/)

Kalceks JSC, 53

Krustpils Street, Riga,

LV-1057 - batch

releaser (HBM

Pharma s.r.o.,



manufacturer,

packager)

Latvia N02AX 1375505.08.2014

05.08.2019PoM/UC

Kalceks JSC, 53


LV-1057, Latvia

3523 Promedol-ZN

trimeperidine

(trimeperidine

hydrochloride)


20mg/ml,

1ml ampoules,


"KPE" Zdorovje

narodu" LLC, 61002,

Kharkov, Melnikova

str. 41

Ukraine N02AX 1634430.12.2016

30.12.2021PoM/UC

"KPE" Zdorovje

narodu" LLC, 61013,

Kharkov, Sevchenko

str. 22, Ukraine

3524 Promez omeprazole capsules20mg,


Protech Biosystems

Pvt. Ltd., Plot No 145-

146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001

India A02BC01 1329904.03.2014

04.03.2019PoM

Protech Biosystems


146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001,

India

3525 Pronoran piribediltablets prolonged-

release coated

50mg,


Les Laboratoires

Servier Industrie, 905,


Gidy

France N04BC08 1551219.04.2016

19.04.2021PoM

Les Laboratoires

Servier, 50, Rue

Carnot 92284

Suresnes cedex,

France

3526Propafenon

Alkaloid

propafenone

(propafenone

hydrochloride)

solution for i/v

injection

3,5mg/ml,


(10/2x5/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C01BC03 1552019.04.2016

19.04.2021PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

772

3527Propafenon

Alkaloid

propafenone

(propafenone

hydrochloride)



Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C01BC03 1612110.11.2016

10.11.2021PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

3528 Propofol-Lipuro propofolemulsion for i/v

injection

10mg/ml,

20ml ampoules (5)

B.Braun Melsungen

AG, Carl-Braun-

Strasse 1, 34212

Melsungen

Germany N01AX10 1405819.12.2014

19.12.2019PoM

B.Braun Melsungen

AG, Carl-Braun-

Strasse 1, 34212

Melsungen, Germany

3529 Propofol-Lipuro propofolemulsion for i/v

injection

10mg/ml,

50ml glass vial

(1, 10)

B.Braun Melsungen

AG, Carl-Braun-

Strasse 1, 34212

Melsungen

Germany N01AX10 1405919.12.2014

19.12.2019PoM

B.Braun Melsungen

AG, Carl-Braun-

Strasse 1, 34212

Melsungen, Germany

3530 Proscar finasteride tablets film-coated

5mg,

blister (14/1x14/,

28/2x14/)

Merck Sharp &

Dohme B.V.

Waarderweg 39,2031

BN Haarlem-batch

releaser (Merck Sharp

& Dohme Ltd.,

Shotton Lane,

Cramlington,

Northumberland

NE23 3JU, UK-

packager), ( AIAC

International Pharma,

LLC, Road #2, 60.3

km Sabana Hoyos,

Arecibo PR, 00688,

Puerto Rico, USA -

bulk manufacturer)

the Netherlands G04CB01 13350/216.05.2017

04.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

773

3531 Proserin-Darnitsa

neostigmine

(neostigmine

methylsulphate)


0,5mg/ml,

1ml ampoules,


Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine N07AA01 1234609.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

3532Prospan cough

dropshedera helix drops oral

20mg/ml,

20ml glass vial-dropper

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden

GermanyR05CA;

herbal drug15680

08.06.2016

08.06.2021OTC

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden,

Germany

3533Prospan cough

syruphedera helix syrup

7mg/ml,


measuring cup

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden

GermanyR05CA;

herbal drug15679

08.06.2016

08.06.2021OTC

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden,

Germany

3534 Prostamed

ground pumpkin

seed (deoiled),

purified dry extract

from deoiled

ground pumpkin

seed, dry extract

from trembling

poplar leaves, dry

extract from golden

rod

tablets chewable

200mg+100mg+

6,3mg+2,6mg,

in plastic container, (60,

120, 200)

Dr. Gustav Klein

GmbH & Co. KG

(Steinenfeld 3, 77736

Zell am Harmersbach)

Germany G04CX 1295628.10.2013

28.10.2018OTC

Dr. Gustav Klein

GmbH & Co. KG


Zell am Harmersbach,

Germany)

774

3535 Prostamol unoserenoae repentis

extractumcapsules soft

320mg,


Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin -

packager, batch

releaser (Catalent

Germany Eberbach

GmbH,

Gammelsbacher str. 2,

Eberbach, 69412,

Germany - bulk

manufacturer)

GermanyG04CX02

herbal drug13772

05.09.2014

05.09.2019PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

3536 Prostamol unoserenoa repens

extractcapsules soft

320mg,


Berlin-Chemie AG

(Menarini Group),

Glienicker Weg 125,

12489 Berlin -

packager, batch

releaser, Sanofi-

Aventis S.p.A., Strada

Statale N17- km22,

67019 Scoppito, Italy-

bulk manufacturer

GermanyG04CX;

herbal drug14227

20.02.2015

20.02.2020PoM

Berlin-Chemie

AG,(Menarini

Group), Glienicker

Weg 125, 12489

Berlin, Germany

3537 Prosterid finasteride tablets film-coated

5mg,


28/2x14/)


Gyomroi ut 19-21,

1103 Budapest

Hungary G04CB01 1230822.03.2013

22.03.2018PoM

Gedeon Richter


21, 1103 Budapest,

Hungary

3538Protamine sulfate

Injection 10mg/mlprotamine sulfate solution for injection

10mg/ml,

5ml ampoules (5)

Swiss Parenterals Pvt.

Ltd., 809 Kerala

Industrial Estate ,

G.I.D.C, Near Bavla,

Dist. Ahmedabad-382

220,Gujarat

India V03AB14 1381405.09.2014

05.09.2019PoM

Swiss Parenterals Pvt.

Ltd., 809 Kerala

Industrial Estate ,

G.I.D.C, Near Bavla,

Dist. Ahmedabad-382

220,Gujarat, India

775

3539 Proton 20mg omeprazolecapsules hard gastro-

resistant

20mg,


56/8x7/)

Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels - batch


manufacturer,


Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal)

Belgium A02BC01 1321224.02.2014

24.02.2019PoM

Brupharmexport

SPRL, Rue de la

Grotte, 14, B-1020,

Brussels, Belgium

3540 Proton 40mg omeprazolecapsules hard gastro-

resistant

40mg,


56/8x7/)

Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels - batch


manufacturer,


Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal)

Belgium A02BC01 1321324.02.2014

24.02.2019PoM

Brupharmexport

SPRL, Rue de la

Grotte, 14, B-1020,

Brussels, Belgium

3541 Protopic 0,3mg/g

tacrolimus

(tacrolimus

monohydrate)

ointment for topical

application

0,3mg/g,

plastic tube 10g, 30g, 60g

Astellas Ireland Co.,

Kerry County,

Killorglin, Ireland-

secondary

packager,batch

releaser Astellas

Pharma Tech Co.,

Ltd., 2-178 Kojin-

machi, Toyama city,

Toyama 930-0809,

Japan-bulk

manufacturer,

primary packager

Ireland D11AX14 14151/103.11.2017

29.12.2019PoM

LEO Pharma A/S,

Industriparken 55,

DK-2750 Ballerup,

Denmark

776

3542 Protopic 1mg/g

tacrolimus

(tacrolimus

monohydrate)

ointment for topical

application

1mg/g,

plastic tube 10g, 30g, 60g

Astellas Ireland Co.,

Kerry County,

Killorglin, Ireland-

secondary

packager,batch

releaser Astellas

Pharma Tech Co.,

Ltd., 2-178 Kojin-

machi, Toyama city,

Toyama 930-0809,

Japan-bulk

manufacturer,

primary packager

Ireland D11AX14 14152/103.11.2017

29.12.2019PoM

LEO Pharma A/S,

Industriparken 55,

DK-2750 Ballerup,

Denmark

3543 Psilo-Balsam

diphenhydramine

(diphenhydramine

hydrochloride)

gel10mg/g,

20g aluminium tube

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia D04AA32 1411929.12.2014

29.12.2019OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

3544 Psoriderm

clobetasol

(clobetasol

propionate)

cream0,5mg/g,

25g aluminium tube

Birzeit

Pharmaceutical

Company (BPC) ,

Ramallah,Industrial

Zone

Palestine D07AD01 1218601.02.2013

01.02.2018PoM

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Ramallah-

Elmasion, Emil habibi

st.17, Palestine

3545 Psoriderm

clobetasol

(clobetasol

propionate)

ointment0,5mg/g,

25g aluminium tube

Birzeit

Pharmaceutical

Company (BPC),

Ramallah,Industrial

Zone

Palestine D07AD01 1218701.02.2013

01.02.2018PoM

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Ramallah-

Elmasion, Emil habibi

st.17, Palestine

777

3546 Psoriderm

clobetasol

(clobetasol

propionate)

solution for topical

use

0,5mg/ml,


Birzeit

Pharmaceutical

Company (BPC),

Ramallah,Industrial

Zone, P.O. box 79

Palestine D07AD01 1615623.11.2016

23.11.2021PoM

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Jerusalem,

P.O. box 51621,

Palestine

3547 Puregonfollitropin beta

(recombinant)

solution for s/c

injection

600IU/0,72ml, 0,78ml

cartridge, needles

(6/2x3/)

Organon (Ireland)

Ltd., Drynam Road,


batch releaser,

secondary packager

(dosage form

manufacturer,

primary packager -

Vetter Pharma-

Fertigung GmbH &

Co. KG, Mooswiesen

2, 88214 Ravensburg,

Germany)

Ireland G03GA06 12936/108.01.2014

07.10.2018PoM

Merck Sharp &

Dohme Idea AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland


(recombinant)

solution for s/c

injection

300IU/0,36ml, 0,42ml

cartridge, needles

(6/2x3/)

Organon (Ireland)

Ltd., Drynam Road,


batch releaser,

secondary packager

(dosage form

manufacturer,

primary packager -

Vetter Pharma-

Fertigung GmbH &

Co. KG, Mooswiesen

2, 88214 Ravensburg,

Germany)

Ireland G03GA06 12937/108.01.2014

07.10.2018PoM

Merck Sharp &

Dohme Idea AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

778


(recombinant)

solution for s/c

injection

300IU/0,36ml, 0,42ml

cartridge and (6/2x3/)

needles

N.V. Organon,


CC OSS-secondary

packager, batch

releaser(legal address -

N.V. Organon,


AB Oss, the

Netherlands) (Vetter

Pharma-Fertigung

GmbH & Co. KG,

Mooswiesen 2, 88214


bulk manufacturer,

primary packager)


15.05.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland


(recombinant)

solution for s/c

injection

600IU/0,72ml, 0,78ml

cartridge and (6/2x3/)

needles

N.V. Organon,


CC OSS-secondary

packager, batch

releaser(legal address -

N.V. Organon,


AB Oss, the

Netherlands) (Vetter

Pharma-Fertigung

GmbH & Co. KG,

Mooswiesen 2, 88214


bulk manufacturer,

primary packager)


15.05.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

779

3551 Puroxan doxofylline syrup

20mg/ml,


measuring spoon

M & H

Manufacturing Co.

Ltd., 41 Sukhumvit

Road, Paknam,

Muang, Samutprakarn

10270

Thailand R03DA11 1260821.06.2013

21.06.2018PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat ,

Belgium

3552 Puroxan doxofylline tablets

400mg,


20/2x10)

M & H

Manufacturing Co.

Ltd., 41 Sukhumvit

Road, Paknam,

Muang, Samutprakarn

10270

Thailand R03DA11 1264904.07.2013

04.07.2018PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

3553 Pyrantelpyrantel (pyrantel

embonate)tablets

250mg,

in blister (3/1x3/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland P02CC01 1600606.10.2016

06.10.2021PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski, Poland

3554 Pyrazinamide pyrazinamide tablets

400mg,


672/24x28/)

Macleods


Plot No 25-27, Sr. No

366, Premier Ind.

Estate, Kachigam,

Daman-396210 (UT)

India J04AK01 1601406.10.2016

06.10.2021PoM

Macleods


304, Atlanta Arcade,

Marol Church

Road,Andheri (East),

Mumbai-400 059,

India

3555Pyrazinamide

tablets BP 400mgpyrazinamide tablets

400mg,

in plastic container

(1000), in blister

(672/24x28/)

Cadila


Plot No. 1389, Trasad

Road, Dholka-387

810, Ahmedabad,

Gujarat State

India J04AK01 1674805.06.2017

05.06.2022PoM

Cadila


Plot No. 1389, Trasad

Road, Dholka-387

810, Ahmedabad,

Gujarat State, India

780

3556 Pyridoxine

pyridoxine

(pyridoxine

hydrochloride)

solution for s/c, i/m

and i/v injection

50mg/ml,

1ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaA11HA02 13592

10.06.2014

10.06.2019PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

3557 Qlaira

I tablet-dark yellow-

estradiol (estradiol

valerate), II tablet-

pink- estradiol

(estradiol valerate),

dienogest, III tablet-

light yellow-


valerate), dienogest,

IV tablet-red-


valerate), V tablet-

white-inactive

tablets film-coated

3mg+(2mg+2mg)+

(2mg+3mg)+1mg, in

blister (28/1x28/(2-I

tablet)(5-II tablet)/(17-III

tablet)(2-IV tablet)(2-V

tablet)/)

Bayer Weimar GmbH

& Co. KG,

Dobereinerstrasse 20,

99427 Weimar

Germany G03AB08 1536526.02.2016

26.02.2021PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

3558 Quadrica H

lisinopril (lisinopril

dihydrate),

hydrochloro-

thiazide

tablets20mg+12,5mg,


Aversi-Rational Ltd.,

14 Chirnakhuli str.

0198 Tbilisi -

secondary packager,

batch releaser

(Twilight Litaka

Pharma Ltd, B-22, H

Block, M.I.D.C.,

Pimpri, Pune 411 018,

India-bulk

manufacturer,

primary packager)

Georgia C09BA03 1375325.07.2014

25.07.2019PoM

Aversi-Rational Ltd.,

14 Chirnakhuli str.


3559 Quamatel famotidine

powder lyophilized

for solution for

injection

20mg,

glass vials (5) and

5ml solvent in ampoules

(5)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary A02BA03 1400726.11.2014

26.11.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

781

3560 Quamatel famotidine tablets film-coated20mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary A02BA03 1400826.11.2014

26.11.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3561 Quamatel famotidine tablets film-coated40mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary A02BA03 1400926.11.2014

26.11.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3562 Quinax

azapentacene

(azapentacene

polysulfonate

sodium)

drops eye (solution)

0,15mg/ml,


dropper

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01XA 1410229.12.2014

29.12.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

3563 Quinvaxem inj.

diphtheria toxoid,

tetanus toxoid,

pertussis antigen,

hib conjugate,

hepatitis B surface

antigen

suspension for

injection

not less than 30IU/0.5ml,

not less than 60IU/0.5ml,

not less than 4.0IU/0.5ml,

35mcg/0.5ml,

10mcg/0.5ml,


Janssen Vaccines

Corp., (Songdo-

dong)23, Harmony-ro

303beon-gil, Yeonsu-

gu, Incheon, 22014

Korea SouthJ07CA;

vaccine16451

06.03.2017

06.03.2022PoM

Janssen Vaccines

Corp., (Songdo-

dong)23, Harmony-ro

303beon-gil, Yeonsu-

gu, Incheon, 22014,

Korea South

3564 Qutenza capsaicintransdermal

therapeutic system

179mg/280cm^2,

sachet and 50g cleansing

gel in tube

GP Grenzach

Produktions GmbH,

Emil-Barell-Strasse 7,

D-79639 Grenzach-

Wyhlen- batch

releaser, secondary

packager, LTS

Lohmann Therapie-

Systeme AG,

Lohmannstrasse 2,

Andernach, 56626,

Germany- bulk

manufacturer,

primary packager

Germany N01BX04 1666611.05.2017

11.05.2022PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

782

3565Rabeprazole-

Asteria

rabeprazole

(rabeprazole

sodium)

tablets film-coated

20mg,


100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

si, Chungcheongbuk-

do

Korea Sourth A02BC04 1517017.12.2015

17.12.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea

3566

Rabies vaccine

cultural

concentrated

purified

inactivated dried

specific antigen of

rabies virus

Vnukovo-32 strain

lyophilisate for

solution for i/m

injection

2.5IU/ml,

1ml ampoules (5) (1dose)

and 1.1ml ampoules with

solvent (5)

FSUE of Chumakov

IPVE, Village of

Institute of

Poliomyelitis,

Settlement

Moskovskiy, Moscow,

142782

RussiaJ07BG01;

vaccine15021

02.12.2015

02.12.2020PoM

FSUE of Chumakov

IPVE, Village of

Institute of

Poliomyelitis,

Settlement

Moskovskiy, Moscow,

142782, Russia

3567 Ramipril ramipril tablets10mg,


Lek S.A., ul.

Domaniewska 50C,

Warszawa, 02-672-

batch releaser,

packager, Lek S.A.,16

Podlipie Str., 95-010

Strykow, Poland-bulk

manufacturer

Poland C09AA05 1636330.12.2016

30.12.2021PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

3568 Ramipril ramipril tablets5mg,


Lek S.A., ul.

Domaniewska 50C,

Warszawa, 02-672-

batch releaser,

packager, Lek S.A.,16

Podlipie Str., 95-010

Strykow, Poland-bulk

manufacturer

Poland C09AA05 1636430.12.2016

30.12.2021PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

3569 Ranexa 1000 ranolazinetablets prolonged-

release

1000mg,


Menarini-Von

Heyden GmbH,


01097 Dresden

Germany C01EB18 1562024.05.2016

24.05.2021PoM

Menarini

International O. L.

S.A., 1, Avenue de la

Gare, 1611,

Luxembourg

783

3570 Ranexa 500 ranolazinetablets prolonged-

release

500mg,


Menarini-Von

Heyden GmbH,


01097 Dresden

Germany C01EB18 1562124.05.2016

24.05.2021PoM

Menarini

International O. L.

S.A., 1, Avenue de la

Gare, 1611,

Luxembourg

3571 Ranitac ranitidine tablets coated150mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA02BA02 13127

10.01.2014

10.01.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3572 Ranitidine

ranitidine

(ranitidine

hydrochloride)


in strip (30/3x10/)

Hemofarm D.O.O.

Sabac, 15000, Sabac,

Hajduk Veljkova str.

No: bb

Serbia A02BA02 1379405.09.2014

05.09.2019PoM

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

3573 Ranitidine

ranitidine

(ranitidine

hydrochloride)



Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.

Vrsac, branch plant

Sabac, 15000, Sabac,

Hajduk Veljkova str.

No: bb, Serbia-bulk

manufacturer,

packager

Serbia A02BA02 1627719.12.2016

19.12.2021PoM

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

3574 Ranitidine ranitidine tablets film-coated

150mg,


20/2x10/)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine A02BA02 1630930.12.2016

30.12.2021PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

784

3575 RanTi

ranitidine

(ranitidine

hydrochloride)

tablets film-coated

150mg,


20/2x10/, 50/5x10/,

100/10x10/)

Medicon

Pharmaceuticals Ltd,

Industral Plot

No.17/A-1, Block-D,

Section-10, Mirpur,

Dhaka

Bangladesh A02BA02 12725/123.09.2013

23.07.2018PoM

Medicon

Pharmaceuticals Ltd,

Industral Plot

No.17/A-1, Block-D,

Section-10, Mirpur,

Dhaka, Bangladesh

3576 Rasilez HCT

aliskiren (aliskiren

hemifumarate),

hydrochloro-

thiazide

tablets film-coated

150mg+25mg,


28/2x14/)

Novartis Farma S.p.A.,

Via Provinciale Schito

131, 80058 Torre

Annunziata, (NA)

Italy C09XA52 1594029.08.2016

29.08.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

3577 Rasilez HCT


hemifumarate),

hydrochloro-

thiazide

tablets film-coated

300mg+25mg,


28/2x14/)



131, 80058 Torre

Annunziata, (NA)

Italy C09XA52 1594129.08.2016

29.08.2021PoM

Novartis Pharma AG,


Basel, Switzerland

3578 Rasilez HCT


hemifumarate),

hydrochloro-

thiazide

tablets film-coated

300mg+12,5mg,


28/2x14/)



131, 80058 Torre

Annunziata, (NA)

Italy C09XA52 1594229.08.2016

29.08.2021PoM

Novartis Pharma AG,


Basel, Switzerland

3579 Rasilez HCT


hemifumarate),

hydrochloro-

thiazide

tablets film-coated

150mg+12,5mg,

in blister, (14/1x14/,

28/2x14/)



131, 80058 Torre

Annunziata, (NA)

Italy C09XA52 1594329.08.2016

29.08.2021PoM

Novartis Pharma AG,


Basel, Switzerland

3580 Rawel SR indapamidetablets prolonged-

release film-coated

1,5mg,


60/6x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C03BA11 1401826.11.2014

26.11.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

785

3581 RBU-200 ibuprofen tablets film-coated200mg,


Medicamen Biotech

Ltd., SP-1192, A&B,

Phase-4, Industrial

Area, Bhiwadi, Distt.

Alwar, Rajasthan

301019

India M01AE01 1480004.09.2015

04.09.2020OTC

Veejay

Pharmaceutical Pvt.

Ltd., D. No 9-34/6,

Plot 8A, SV Nagar,

Kessara (M), Nagaram

(V), SV Road No 6,

OPP To Gayatri

Nivas, Near Vijaya

Hospitals Ecil X

Roads, Secunderabaad

Ap, 500083, India

3582 RBU-400 ibuprofen tablets film-coated400mg,


Medicamen Biotech

Ltd., SP-1192, A&B,

Phase-4, Industrial

Area, Bhiwadi, Distt.

Alwar, Rajasthan

301019

India M01AE01 1480104.09.2015

04.09.2020OTC

Veejay

Pharmaceutical Pvt.

Ltd., D. No 9-34/6,

Plot 8A, SV Nagar,

Kessara (M), Nagaram

(V), SV Road No 6,

OPP To Gayatri

Nivas, Near Vijaya

Hospitals Ecil X

Roads, Secunderabaad

Ap, 500083, India

3583 Rebetol ribavirin capsules200mg,



N.V, Industriepark

30, B-2220, Heist op-

den-Berg - packager,

batch releaser (MSD

International GmbH

(Puerto Rico Branch)

LLC, Pridco Indus

Park, SR 183, Las

Piedras, Puerto Rico

(PR) 00771, USA -

bulk manufacturer)

Belgium J05AB04 1377805.09.2014

05.09.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

786

3584 ReciGen interferon beta-1asolution for s/c

injection

44mcg (12MIU)/0,5ml,

0,5ml pre-filled syringe

(12)

CinnaGen Co., West

6th St., 3rd Sq.,

Simindasht Industrial

Area, Karaj, Alborz

Iran L03AB07 1657303.04.2017

03.04.2022PoM

CinnaGen Co., West

6th St., 3rd Sq.,

Simindasht Industrial

Area, Karaj, Alborz,

Iran

3585 Recormon epoetin betasolution for s/c and

i/v injection

2000IU/0,3ml, 0,3ml pre-

filled syringes (6) and

needles (6)

Roche Diagnostics

GmbH Sandhofer

Strasse 116 D-68305

Mannheim

Germany B03XA 1350730.05.2014

30.05.2019PoM

F. Hoffmann-La

Roche Ltd.,

Switzerland


CH-4070 Basel

3586 Rectodelt 100 prednisone suppositories rectal100mg,

(2)

Trommsdorff GmbH

& Co. KG,

Arzneimittel,

Trommsdorffstrasse 2-

6, 52477, Alsdorf

Germany H02AB07 1570522.06.2016

22.06.2021PoM

Trommsdorff GmbH

& Co. KG,

Arzneimittel,


6, 52477, Alsdorf,

Germany

3587 Refacto AF 1000IU moroctocog alfapowder for solution

for injection

1000IU,

glass vial, 4ml solvent in

pre-filled syringe, vial

adapter, sterile infusion

set, (2) alcohol swabs,

plaster, gauze pad

Wyeth Farma S.A.

Autovվa del Norte A-

1 Km 23. Desvio

Algete, Km 1 28700

San Sebastian de los

Reyes Madrid

Spain B02BD02 1320410.01.2014

10.01.2019PoM

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13

9NJ, UK


for injection

250IU,





plaster, gauze pad

Wyeth Farma S.A.,

Autovia del Norte A-

1 Km 23, Desvio

Algete Km 1, 28700


Reyes, Madrid

Spain B02BD02 1320210.01.2014

10.01.2019PoM

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13

9NJ, UK

787


for injection

500IU,





plaster, gauze pad

Wyeth Farma S.A.,

Autovia del Norte A-

1 Km 23, Desvio

Algete Km 1, 28700


Reyes, Madrid

Spain B02BD02 1320310.01.2014

10.01.2019PoM

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13

9NJ, UK

3590 Regulaxsenna leaves, senna

fruitcubes

710mg+300mg,

(6)

Krewel Meuselbach

GmbH, Xavier-

Vorbruggen str. 6,

98708 Gehren

GermanyA06AB06;

herbal drug17142

07.11.2017

07.11.2022OTC

Krewel Meuselbach

GmbH, Krewel str. 2,

53783 Eitorf,

Germany

3591Regulax

Picosulphate

sodium picosulfate

(sodium picosulfate

monohydrate)

drops oral7,5mg/ml,

20ml glass bottle

Krewel Meuselbach


53783 Eitorf - batch

releaser (Krewel

Meuselbach GmbH,

Xavier-Vorbruggen

str. 6, 98708 Gehren,

Germany - bulk

manufacturer,

packager)

Germany A06AB08 1383718.09.2014

18.09.2019OTC

Krewel Meuselbach


53783 Eitorf,

Germany

3592 Regulondesogestrel,

ethinylestradioltablets film-coated

0,15mg+0,03mg,


63/3x21/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AA09 1713607.11.2017

07.11.2022PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3593 Rehyd solution

sodium chloride,

sodium citrate,

potassium chloride,

glucose (glucose

monohydrate)

solution oral with

banana flavour

17,5mg+14,5mg+ 12,5mg+

55,7mg, 330ml plastic

bottle

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22

Republic of

ArmeniaA07CA 17119

23.10.2017

23.10.2022OTC


Ararat province,

Masis city, Masis


22, Republic of

Armenia

788

3594 Rehydron

sodium chloride,

potassium chloride,

sodium citrate,

glucose anhydrous

powder dosed

3,5g+2,5mg+

2,9mg+10mg, 18,9g

sachets (20)

Orion Corporation,

Orionintie 1, 02200

Espoo - batch releaser

(Etnovia Oy,

Teollisuustie 16-18,

Seinajoki, FI- 60100,

Finland - bulk

manufacturer,

packager)

Finland A07CA 1391229.10.2014

29.10.2019OTC

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

3595 Rehydron

sodium chloride,

potassium chloride,

sodium citrate,

glucose anhydrous

powder dose3,5g+2,5g+2,9g+ 10g,

18,9g sachet (20)

Recipharm Parets

S.L., C/Ramon and

Cajal 2 , 08150 Parets

del Valles (Barcelona)

Spain A07CA 1709623.10.2017

23.10.2022OTC

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

3596 Relanium diazepamsolution for i/v and

i/m injection

5mg/ml,

2ml ampoules (5, 50)

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw

Poland N05BA01 1491520.10.2015

20.10.2020PoM/UC

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw,

Poland

3597 Relenza zanamivirpowder for

inhalation

5mg, diskhaler (1) or

rotadisks (5), (each of the

rotadisks contains 4 doses

of powder for inhalation)

Glaxo Wellcome

Production, Zone

Industrielle No. 2, 23

Rue Lavoisier, 27000

Evreux

France J05AH01 1310710.12.2013

10.12.2018PoM

Glaxo Wellcome UK

Ltd, trading as:

GlaxoSmithKline UK

Stockley Park West,

Uxbridge, Middlesex,

UB11 1BT, UK

3598 Relief

phenylephrine

(phenylephrine

hydrochloride)

suppositories rectal5mg,

in strip (12/2x6/)

Istituto De Angeli

S.r.l., Localita Prulli

103/c-50066 Reggelo

Italy C05AX 1656103.04.2017

03.04.2022OTC

Bayer Consumer Care

AG, Peter Merian-

Strasse 84, 4052 Basel,

Switzerland

789

3599 Relief

phenylephrine

(phenylephrine

hydrochloride)

ointment rectal

2,5mg/g,

28.4g laminated tube and

applicator

Famar S.A.,National

Road Athens-Lamia,

Km 49, 19011 Avlona

Greece C05AX 1720408.12.2017

08.12.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

3600 Relief Advance benzocaine suppositories rectal206mg,

in strip (12/2x6/)

Istituto De Angeli

S.r.l., Localita Prulli

103/c-50066 Reggelo

Italy C05AX 1656203.04.2017

03.04.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

3601 Relief Advance benzocaine ointment rectal

200mg/g,

28.4g laminated tube and

applicator

Famar S.A.,National

Road Athens-Lamia,

Km 49, 19011 Avlona

Greece C05AX 1720308.12.2017

08.12.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

3602 Relief Ultra

hydrocortisone

acetate, zinc sulfate

monohydrate, shark

liver oil

suppositories rectal10mg+11mg+ 60mg,

in strip (12/2x6/)

Istituto De Angeli

S.R.L. Loc. Prulli,

103/C 50066 Reggelo

Italy C05AA01 1215801.02.2013

01.02.2018OTC

Bayer Consumer Care

AG, Peter Merian

strasse 84 CH-4052

Basel, Switzerland

3603 Relium diazepam tablets film-coated5mg,


Tarchomin

Pharmaceutical

Works "Polfa" S.A.,


176 Warsaw

Poland N05BA04 1582020.07.2016

20.07.2021PoM/UC

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,


176 Warsaw, Poland

790

3604 Relpax

eletriptan

(eletriptan

hydrobromide)


in blister (2)

R-Pharm Germany

GmbH, Heinrich-

Mack-Str. 35, 89257,

Illertissen-batch

releaser, secondary

packager, Pfizer Italia

S.r.l. Localita Marino

del Tronto, 63100

Ascoli Piceno, Italy-

bulk manufacturer,

primary packager

Germany N02CC06 1665211.05.2017

11.05.2022PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street, New

York 10017, USA

3605 Relvar Ellipta

fluticasone

(fluticasone

furoate), vilanterol

powder for

inhalation

100mcg/dose+

25mcg/dose, powder in

strip (60/2x30/ dose) in

plastic inhaler

Glaxo Operations UK

Ltd, Priory Street,

Ware, Hertfordshire

SG12 0DJ

UK R03AK10 1534626.02.2016

26.02.2021PoM

Glaxo Group Limited,

980 Great West Road,


TW8 9GS, UK

3606 Relvar Ellipta

fluticasone

(fluticasone

furoate), vilanterol

powder for

inhalation

200mcg/dose+

25mcg/dose, powder in

strip (60/2x30/ dose) in

plastic inhaler

Glaxo Operations UK

Ltd, Priory Street,

Ware, Hertfordshire

SG12 0DJ

UK R03AK10 1534726.02.2016

26.02.2021PoM

Glaxo Group Limited,



TW8 9GS, UK

3607 Remantadin

rimantadine

(rimantadine

hydrochloride)

capsules

100mg,

in blister (10/1x10,

30/3x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia J05AC02 1656403.04.2017

03.04.2022OTC

Olainfarm JSC, 5


LV-2114, Latvia

3608 Remens

cimicifuga racemosa

D1, sanguinaria

canadensis D6,

jaborandi D6, sepia

officinalis D12,

lachesis mutus D12

drops oral

5ml/100ml+ 10ml/100ml+

10ml/100ml+

10ml/100ml+

10ml/100ml,

50ml glass bottle-dropper

Richard Bittner AG,

Ossiacherstrasse 7, A-

9560 Feldkirchen

Austria

G02CX;

homeopathic

drug

1565019.05.2016

19.05.2021OTC

Richard Bittner AG,

Reisnerstrasse 55-57,

A-1030 Wien, Austria

791

3609 Remens

cimicifuga racemosa

D1, sanguinaria

canadensis D6,

jaborandi D6, sepia

officinalis D12,

lachesis mutus D12

tablets sublingual

17,9mg+37,2mg+

37,2mg+37,2mg+ 37,2mg,


36/3x12/)

Richard Bittner AG,

Ossiacherstrasse 7, A-

9560 Feldkirchen

Austria

G02CX;

homeopathic

drug

1565119.05.2016

19.05.2021OTC

Richard Bittner AG,

Reisnerstrasse 55-57,

A-1030 Wien, Austria

3610 Remicade infliximab

powder lyophilized

for concentrate for


100mg,

20ml glass vial

Cilag AG, Hochstrasse

201, CH-8205

Schaffhausen

Switzerland

L04AB02

new

indication

1261321.06.2013

21.06.2018PoM

Johnson & Johnson

LLC, 121614,

Moscow, Str.

Krylatskaya 17/ 2,

Russia

3611 Remycin 100

doxycycline

(doxycycline

hyclate)


in blister (10)

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon


Cyprus J01AA02 1248917.05.2013

17.05.2018PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

3612Reneira 150mg

capsulespregabalin capsules hard

150mg,

in blister (14/2x7)

Lek Pharmaceuticals

d.d.,Trimlini 2D,

Lendava, 9220-batch

releaser, packager,

Sandoz Ilac Sanayi ve

Ticaret A.S., Inoenue

Mahallesi, Gebze

Plastikciler Organize

Sanayi Boelgesi

Atatturk Bulvari 9,

Cadde No.2, 41400,

Kocaeli, Turkey- bulk

manufacturer

Slovenia N03AX16 1723708.12.2017

08.12.2022PoM/UC

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

792

3613 Rengalin

affinity purified

antibodies to

bradykinin, affinity

purified antibodies

to histamine,

affinity purified

antibodies to

morphine

tablets to be sucked

6mg+6mg+6mg;

(10/1x10/), (20/2x10/) and

(50/5x10/) in blister

NPF Materia Medica

Holding LLC, 54,

Buguruslanskaya st.,

Chelyabinsk 454139

Russia

R05DB;

homeopathic

drug

1722408.12.2017

08.12.2022OTC

NPF Materia Medica

Holding LLC, 9 bld.,

3rd Samotyochny

per., Moscow 127473,

Russia

3614 Renitecenalapril (enalapril

maleate)tablets

5mg,


14/1x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, Merck Sharp

& Dohme Ltd.,

Shotton Lane,

Cramlington

Northumberland

NE23 3JU, United

Kingdom -bulk

manufacturer,

packager

the Netherlands C09AA02 14154/114.12.2015

29.12.2019PoM

Schering-Plough

Central East Ag,

Weystrasse 20, 6000

Lucerne 6,

Switzerland


maleate)tablets

10mg,


14/1x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, Merck Sharp

& Dohme Ltd.,

Shotton Lane,

Cramlington

Northumberland

NE23 3JU, United

Kingdom -bulk

manufacturer,

packager


29.12.2019PoM

Schering-Plough

Central East Ag,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

793


maleate)tablets

20mg,


14/1x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -

packager, batch


manufacturer - Merck

Sharp & Dohme Ltd.,

Shotton Lane,

Cramlington,

Northumberland

NE23 3JU, United

Kingdom)


29.12.2019PoM

Merck Sharp &

Dohme Idea AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland


maleate)tablets

10mg,


Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Merck Sharp &

Dohme Ltd., Shotton

Lane, Cramlington,

Northumberland

NE23 3JU, UK -bulk

manufacturer

the Netherlands C09AA02 1633130.12.2016

30.12.2021PoM

Schering-Plough

Central East Ag,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland


maleate)tablets

20mg,


Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Merck Sharp &

Dohme Ltd., Shotton

Lane, Cramlington,

Northumberland

NE23 3JU, UK -bulk

manufacturer


30.12.2021PoM

Schering-Plough

Central East Ag,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

794


maleate)tablets

5mg,


Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Merck Sharp &

Dohme Ltd., Shotton

Lane, Cramlington,

Northumberland

NE23 3JU, UK -bulk

manufacturer


30.12.2021PoM

Schering-Plough

Central East Ag,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

3620 Rennie

calcium carbonate,

magnesium

carbonate

tablets chewable

with menthol flavor

680mg+80mg,


24/2x12/)

Bayer Sante Familiale,

33, rue de l'industrie,

74240 Gaillard

France A02AD 1288527.09.2013

27.09.2018OTC

Bayer Consumer Care

AG, Peter Merian-

Strasse 84. 4052 Basel,

Switzerland

3621 Rennie

calcium carbonate,

magnesium

carbonate

tablets chewable

with orange flavour

680mg+80mg,


Delpharm Gaillard,


74240 Gaillard

France A02AD 1673605.06.2017

05.06.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

3622 Reparil-gel Nescin, diethylamine

salicylategel for external use

0.01g/g+0.05g/g, 40g

aluminium tube

Madaus GmbH,

Luetticher Strasse

5,Troisdorf, 53842

Germany M02AC 1562824.05.2016

24.05.2021OTC

Madaus GmbH,

51101 Cologne,

Germany

3623 Retabolil

nandrolone

(nandrolone

decanoate)


oily

50mg/ml,

1ml ampoule (1)


Gyomroi ut 19-21,

1103 Budapest

Hungary A14AB01 1417016.01.2015

16.01.2020PoM

Gedeon Richter


21, 1103 Budapest,

Hungary

3624 Retinalamincattle eye retina

polypeptides

powder lyophilized


and parabulbar

injection

5mg,

5ml glass vials (10)

Geropharm Ltd,

196158 Saint

Petersburg,

Moskovskoe shosse,

13, lit. VL.

Russia S01XA 1302125.11.2013

25.11.2018PoM

Geropharm Ltd,

191119 Saint

Petersburg,

Zvenigorodskaya ul.

9, Russia

795

3625 Retinalamincattle eye retina

polypeptides

powder lyophilized


and parabulbar

injection

5mg,

5ml glass vials, in blister

(10/2x5/)

"Geropharm" Ltd,

building 83, lit. AAN,

Obolensk, Serpukhov

district, Moscow

region, 142279

Russia S01XA 1547802.04.2016

02.04.2021PoM

"Geropharm" Ltd, 9

Zvenigorodskaya st.,

191119 Saint

Petersburg, Russia

3626 Retinol retinol palmitate capsules100000IU,


Altayvitamini CJSC,

659325, The Altay


Zavodskaya Str.

Russia A11CA01 1330104.03.2014

04.03.2019OTC

Altayvitamini CJSC,

659325, The Altay


Zavodskaya Str.,

Russia

3627 Retinol acetate retinol acetate capsules

33000IU,


30/3x10/)

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx 121

Russia A11CA01 12913/108.01.2014

07.10.2018OTC

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

3628

Retinol acetate

3,44% solution for

oral use and

external

application the oil

retinol (retinol

acetate)

solution oily for oral

and external use

34,4mg/ml,

10ml, 50ml glass vial,


Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-


Russia A11CA01 1227722.03.2013

22.03.2018OTC

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, RUSSIA

3629

Retinol acetate

8,60% solution for

oral use and

external

application the oil

retinol (retinol

acetate)

solution oily for oral

and external use

86mg/ml,

10ml, 50ml glass vial,


Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-


Russia A11CA01 1227822.03.2013

22.03.2018OTC

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, RUSSIA

3630 Revit

vitamin A,vitamin

B1, vitamin B2,

vitamin C

dragee

2500IU+1mg+

1mg+35mg,


Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A11BA 1374925.07.2014

25.07.2019OTC

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

796

3631 Revolade

eltrombopag

(eltrombopag

olamine)



Glaxo Wellcome S.A.,

Avenida de

Extremadura, 3,

09400 Aranda de

Duero, Burgos -

primary packager,

batch releaser (Glaxo

Operations UK

Limited (trading as:

Glaxo Wellcome

Operations), Priory

Street, Ware,

Hertfordshire, SG12

0DJ, UK - bulk

manufacturer,

secondary packager)

Spain B02BX05 13689/122.10.2014

16.07.2019PoM

GlaxoSmithKline

Trading Services

Limited, Currabinny,

Carrigaline, County

Cork, Ireland

3632 Revolade

eltrombopag

(eltrombopag

olamine)




Avda Extremadura, 3,

09400 Aranda de

Duero, Burgos-batch

releaser, packager,

Glaxo Operations UK

Ltd, Priory Street,

Ware, Hertfordshire,

SG12 0DJ, UK- bulk

manufacturer

Spain B02BX05 1661825.04.2017

25.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

3633 Rexetin

paroxetine

(paroxetine

hydrochloride

hemihydrate)



Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N06AB05 1634030.12.2016

30.12.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

797

3634 Rezalut Pro soya phospholipids capsules soft300mg,


Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin -

packager, batch

releaser, Catalent

Germany Eberbach

GmbH,

Gammelsbacherstrass

e 2, D-69412

Eberbach, Germany-

bulk manufacturer

Germany A05B 1518017.12.2015

17.12.2020OTC

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611 L-1611,

Luxembourg

3635Rheopolyglucin-

PharmaTechdextran 40 solution for infusion

100mg/ml,

100ml, 200ml, 250ml,


PharmaTech CJSC,


str. 111

Republic of


15.12.2015

15.12.2020PoM

PharmaTech CJSC,



Armenia

3636Rhesonativ

625IU/ml

human anti-D

immunoglobulinsolution for injection

625IU/ml,

1ml ampoule (1)

Octapharma AB, Lars

Forssells gata 23,

Stockholm, 11275-

batch releaser,

Octapharma AB, Lars

Forssells gata 23,

Stockholm, 11275,

Sweden-bulk

manufacturer,

primary packager,

Octapharma Dessau

GmbH,Otto-Reuter-

Str. 3, 06847 Dessau-

Roblau, Germany-

secondary packager

Sweden J06BB01 1591623.08.2016

23.08.2021PoM

Octapharma AB, Lars

Forssells gata 23,

Stockholm, 11275,

Sweden

798

3637Rhesonativ

625IU/ml

human anti-D

immunoglobulinsolution for injection

625IU/ml,


Octapharma AB, Lars

Forssells gata 23,

Stockholm, 11275-

batch releaser,

Octapharma AB, Lars

Forssells gata 23,

Stockholm, 11275,

Sweden-bulk

manufacturer,

primary packager,

Octapharma Dessau

GmbH,Otto-Reuter-

Str. 3, 06847 Dessau-

Roblau, Germany-

secondary packager

Sweden J06BB01 1591723.08.2016

23.08.2021PoM

Octapharma AB, Lars

Forssells gata 23,

Stockholm, 11275,

Sweden

3638 Rhophylac 300immunoglobulin

anti-D (Rh) human


i/m injection

300mcg/2ml,

pre-filled syringe 2ml and

needle, in blister

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22-

batch releaser, bulk

manufacturer, CSL

Behring GmbH, Emil-

von-Behring-Strasse

76, 35041 Marburg,

Germany- primary

and secondary

packager

Switzerland J06BB01 1521530.12.2015

30.12.2020PoM

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22,

Switzerland

3639 Rhydlosart 100losartan (losartan

potassium)tablets film-coated

100mg,


Rhydburg

Pharmaceuticals

Limited, C-2&C-3,

S.I.E.L., Selaqui,

Dehradun,

Uttarakhand

India C09CA01 1224307.03.2013

07.03.2018PoM

Rhydburg

Pharmaceuticals

Limited, C-2&C-3,

S.I.E.L., Selaqui,

Dehradun,

Uttarakhand, India

3640 Rhydlosart 50losartan (losartan


50mg,


Rhydburg

Pharmaceuticals

Limited, C-2&C-3,

S.I.E.L., Selaqui,

Dehradun,

Uttarakhand

India C09CA01 1224207.03.2013

07.03.2018PoM

Rhydburg

Pharmaceuticals

Limited, C-2&C-3,

S.I.E.L., Selaqui,

Dehradun,

Uttarakhand, India

799

3641 Ribomustin

bendamustine

(bendamustine

hydrochloride)

powder for

concentrate for


25mg,

glass vial (1, 5,10, 20)

Haupt Pharma

Wolfratshausen

GmbH, Pfaffenrieder

strasse 5, 82515,

Wolfratshausen-batch

releaser, secondary

packager, Cenexi-

Laboratories Thissen

S.A., Rue de la

Papyree 2-4-6, Braine-

L-Alleud, B-1420,

Belgium-bulk

manufacturer,

primary packager

Germany L01AA09 1574804.07.2016

04.07.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

3642 Ribomustin

bendamustine

(bendamustine

hydrochloride)

powder for

concentrate for


100mg,

glass vial (1, 5)

Haupt Pharma

Wolfratshausen

GmbH, Pfaffenrieder

strasse 5, 82515,

Wolfratshausen-batch

releaser, secondary

packager, Cenexi-

Laboratories Thissen

S.A., Rue de la

Papyree 2-4-6, Braine-

L-Alleud, B-1420,

Belgium-bulk

manufacturer,

primary packager

Germany L01AA09 1574904.07.2016

04.07.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

3643 Riboxin inosine tablets coated200mg,


Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus C01EB 1422520.02.2015

20.02.2020PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

800

3644 Riboxin inosine solution for injection20mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaC01EB 15688

08.06.2016

08.06.2021PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

3645 Riboxin inosine tablets coated 200mg,


Belmedpreparaty

RUE, 220006, Minsk,

Mayakovskogo st. 1

Belarus C01EB 1691508.08.2017

08.08.2022PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

3646 Ricozib-120 etoricoxib tablets film-coated120mg,



B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India M01AH05 1518830.12.2015

30.12.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India




B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India M01AH05 1518730.12.2015

30.12.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India




B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India M01AH05 1518930.12.2015

30.12.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

3649 Ridzowet ronidazolepowder for oral

solution

100mg/g,

300g and 1000g in plastic

container

Drwalewskie Zaklady

Przemyslu

Bioweterynaryjnego

S.A., ul. Grojecka 6,

Drwalew, 05-651

Poland

QP51AA08;

veterinary

drug

1684810.07.2017

10.07.2022OTC

Drwalewskie Zaklady

Przemyslu

Bioweterynaryjnego

S.A., ul. Grojecka 6,

Drwalew, 05-651,

Poland

801

3650 Rifampicin 150mg rifampicin capsules

150mg,


1000/100x10/)


Valea Lupului,

707410 lasi

Romania J04AB02 1682610.07.2017

10.07.2022PoM


Valea Lupului,


3651 Rifampicin 300mg rifampicin capsules

300mg,


1000/100x10/)


Valea Lupului,

707410 lasi

Romania J04AB02 1682510.07.2017

10.07.2022PoM


Valea Lupului,


3652

Rifampicin 60mg-

Isoniazid 30mg

Tablets

rifampicin,

isoniazidtablets dispersible

60mg+30mg,

in strip (84/14x6/)

Lupin Limited, A-

28/1, M.I.D.C.,

Chikalthana,

Aurangabad 431 210

India J04AM02 1705905.10.2017

05.10.2022PoM

Lupin Limited,

Kalpataru Inspire 3rd

Floor, Off Western

Express Highway,

Santacruz(East),

Mumbai 400055,

India

3653Rifampicin

Isoniazid

rifampicin,

isoniazidtablets film-coated

150mg+75mg,

in blister (672/24x28)

Lupin Limited, A-

28/1, M.I.D.C.,

Chikalthana,

Aurangabad 431 210

India J04AM02 1621308.12.2016

08.12.2021PoM

Lupin Limited, 159,

CST Road, Kalina

Santacruz(East),

Mumbai 400098,

India

3654

Rifampicin

Isoniazid

Pyrazinamide

rifampicin,

isoniazid,

pyrazinamide

tablets60mg+30mg+ 150mg,


Lupin Limited, A-

28/1, M.I.D.C.,

Chikalthana,

Aurangabad 431 210

India J04AM05 1621408.12.2016

08.12.2021PoM

Lupin Limited, 159,

CST Road, Kalina

Santacruz(East),

Mumbai 400098,

India

3655

Rifampicin

Isoniazid

Pyrazinamide

Ethambutol

hydrochloride

rifampicin,

isoniazid,

pyrazinamide,

ethambutol

(ethambutol

hydrochloride)

tablets film-coated

150mg+75mg+

400mg+275mg,


Lupin Limited, A-

28/1, M.I.D.C.,

Chikalthana,

Aurangabad 431 210

India J04AM06 1621508.12.2016

08.12.2021PoM

Lupin Limited, 159,

CST Road, Kalina

Santacruz(East),

Mumbai 400098,

India

802

3656 Rigevidonlevonorgestrel,

ethinylestradioltablets coated

0.15mg+0.03mg,


63/3x21/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AA07 1445404.05.2015

04.05.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3657 RIGVIR --- solution for injection>10^6 TCID50/ml; (1)

glass vial 2ml

AS Kevelt,

Teaduspargi 3/1,

Tallinn, EE-12618

Estonia L03AX 1541710.03.2016

10.03.2021PoM

SIA Latima, Kudras

iela 7-8 , Olaine, LV-

2114, Latvia

3658 Rimantadin-STI

rimantadin

(rimantadin

hydrochloride)

tablets50mg,


Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, K. Marksa

str., 124

Russia J05AC02 1281017.09.2013

17.09.2018OTC

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

3659 Rimecor

trimetazidine

(trimetazidine

dihydrochloride)



Makiz-Pharma LLC, 6-

4, 5, 8, Avtomobilny

proezd, Moscow,

109029

Russia C01EB15 1373924.07.2014

24.07.2019PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

3660 Rimecor

trimetazidine

(trimetazidine

dihydrochloride)



Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye highway

Russia C01EB15 1568408.06.2016

08.06.2021PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

3661 Ringer

sodium chloride,

potassium chloride,

calcium chloride

(calcium chloride

dihydrate)


8,6mg/ml+ 0,3mg/ml+

0,33mg/ml,

100ml, 200ml, 250ml,

500ml, 1000ml, 2000ml,

3000ml plastic pack

PharmaTech CJSC,


str. 111

Republic of

ArmeniaB05BB01 15083

15.12.2015

15.12.2020PoM

PharmaTech CJSC,



Armenia

3662 Ringer`s Injection

sodium chloride,

potassium chloride,

calcium chloride


8,6mg/ml+ 0,3mg/ml+

0,49mg/ml,

250ml, 500ml, 1000ml

plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of


09.07.2013

09.07.2018PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Armenia

803

3663 Rinofluimucil

acetylcysteine,tuam

inoheptane

(tuaminoheptane

sulfate)

spray nasal10mg/ml+5mg/ml, 10ml

glass bottle with nebuliser

Zambon S.p.A. Via

Della Chimica, 9,

Vicenza, 36100

Italy R01AB08 1408918.12.2014

18.12.2019OTC

ZAMBON S.P.A., Via

Lillo del Duca, 10

20091 Bresso, Milan,

Italy

3664 Rinomaris

xylometazoline

(xylometazoline

hydrochloride)

spray nasal0.5mg/ml; 10ml plastic

vial

Jadran Galenski

Laboratorij d.d.,

51000 Rijeka, Pulac

b.b. - batch releaser

(dosage form

manufacturer - Jadran

Galenski Laboratorij

d.d., Svilno bb, Cavle,

51219, Croatia)

Croatia R01AA07 1269723.07.2013

23.07.2018OTC

Jadran Galenski

Laboratorij d.d.,

51000 Rijeka, Pulac

b.b., Croatia

3665 Rinomaris

xylometazoline

(xylometazoline

hydrochloride)

spray nasal1mg/ml,

10ml plastic vial

Jadran Galenski

Laboratorij d.d.,

51000 Rijeka, Pulac

b.b. - batch releaser

(dosage form

manufacturer - Jadran

Galenski Laboratorij

d.d., Svilno bb, Cavle,

51219, Croatia)

Croatia R01AA07 1269823.07.2013

23.07.2018OTC

Jadran Galenski

Laboratorij d.d.,

51000 Rijeka, Pulac

b.b., Croatia

3666 Rinostop

xylometazoline

(xylometazoline

hydrochloride)

spray nasal0,5mg/ml,

15ml plastic vial

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia R01AA07 14505/121.04.2016

15.05.2020OTC

OTCPharm PJSC,

123317, Moscow,


Russia

3667 Rinostop

xylometazoline

(xylometazoline

hydrochloride)

spray nasal1mg/ml,

15ml plastic vial

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia R01AA07 14506/102.05.2016

15.05.2020OTC

OTCPharm PJSC,

123317, Moscow,


Russia

804

3668 Rinza

caffeine,

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

chlorphenamine

(chlorphenamine

maleate)

tablets

30mg+500mg+

10mg+2mg,


20/2x10/)

Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals Ltd.),

Survey No. 101/2 and

102/1, Daman

Industrial Estate,

Kadaiya, Daman-396

210

India N02BE71 1688408.08.2017

08.08.2022OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

3669 Risebon

risedronic acid

(risedronate

sodium)


in blister (4/1x4/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice-batch

releaser,

Pharmaceutical

Works Adamed

Pharma Joint Stock

Company, 95-054

Ksawerow, Szkolna

St. 33, Poland- bulk

manufacturer,

packager

Poland M05BA07 1721308.12.2017

08.12.2022PoM

Pharmaceutical

Works Adamed

Pharma Joint Stock

Company, 95-054

Ksawerow, Szkolna

St. 33, Poland

3670 Rispaxol risperidone tablets film-coated

2mg,


(60/6x10/)

GRINDEKS JSC,

Krustpils Street 53,

Riga, LV-1057

Latvia N05AX08 1342214.04.2014

14.04.2019PoM

GRINDEKS JSC,


Riga, LV-1057, Latvia

3671 Rispaxol risperidone tablets film-coated

4mg,


60/6x10/)

GRINDEKS JSC,


Riga, LV-1057

Latvia N05AX08 1342314.04.2014

14.04.2019PoM

GRINDEKS JSC,



805

3672 Risperidone risperidone tablets coated2mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05AX08 16872

31.07.2017

31.07.2022PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3673

Risperidone 1mg

Film-Coated

Tablets

risperidone tablets film-coated

1mg,


60/6x10/)

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB - batch


manufacturer,

packager - Dexcel

Ltd., 1 Dexcel St., Or-

Akiva 30600, Israel)

UK N05AX08 1268115.07.2013

15.07.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

3674

Risperidone 3mg

Film-Coated

Tablets

risperidone tablets film-coated3mg,


Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB - batch


manufacturer -

Dexcel Pharma

Technologies Limited,

10 Hakidma Street,

Northern Hi-tech

City Park, Yokneam,

Israel) (packager -

Dexcel Ltd., 1 Dexcel

St., Or-Akiva 30600,

Israel)

UK N05AX08 1268215.07.2013

15.07.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

806

3675Risperidone-

Remedica 1mgrisperidone tablets film-coated

1մգ,

in blister

(60/6x10/)

Remedica Ltd,

Limassol Industrial

Estate, Aharnon


Cyprus N05AX08 1452629.05.2015

19.03.2020PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

3676Risperidone-


2մգ,

in blister

(60/6x10/)

Remedica Ltd,

Limassol Industrial

Estate, Aharnon


Cyprus N05AX08 1452729.05.2015

19.03.2020PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

3677Risperidone-


3mg,


Remedica Ltd,

Limassol Industrial

Estate, Aharnon


Cyprus N05AX08 1452829.05.2015

19.03.2020PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

3678Risperidone-


4mg,


Remedica Ltd,

Limassol Industrial

Estate, Aharnon


Cyprus N05AX08 1452929.05.2015

19.03.2020PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

3679Risperidone-


6mg,


Remedica Ltd,

Limassol Industrial

Estate, Aharnon


Cyprus N05AX08 1453029.05.2015

19.03.2020PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

3680 Rispolept risperidone solution oral

1mg/ml,

30ml glass vial and

dropper

Janssen

Pharmaceutica N.V.,

Turnhoutseweg 30, B-

2340 Beerse

Belgium N05AX08 1244607.05.2013

07.05.2018PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

807

3681 Rispolept risperidone tablets film-coated2mg,


Janssen Cilag S.p.A.,

Kolonyo-Monceze,

Milan, M. Buonarotty

str., building 23

Italy N05AX08 1349423.05.2014

23.05.2019PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

3682 Rispolept Consta risperidone

powder and solvent

for prolonged-release

suspension for i/m

injection

25mg,

glass vial with powder (1),

pre-filled syringe with

2ml solvent (1), West-

Medimop Vial Adapter

(1), Terumo SurGuard 3

needles (25mm and

51mm) (2)

Cilag AG, Hochstrasse

201, CH-8200

Schaffhausen

Switzerland N05AX08 16072/127.06.2017

26.10.2021PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

3683Rissar 1mg film-

coated tabletsrisperidone tablets film-coated

1mg,



Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia )

Slovenia N05AX08 1248517.05.2013

17.05.2018PoM

Alkaloid Ltd,

Motopista 2, 2

"Ricardo Vakarini"

str., fl. 3, ap. 10 Sofia

1404, Bulgaria



2mg,



Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia )

Slovenia N05AX08 1248617.05.2013

17.05.2018PoM

Alkaloid Ltd,

Motopista 2, 2

"Ricardo Vakarini"


1404, Bulgaria

808



3mg,



Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia )

Slovenia N05AX08 1248717.05.2013

17.05.2018PoM

Alkaloid Ltd,

Motopista 2, 2

"Ricardo Vakarini"


1404, Bulgaria

3686 Rivanol ethacridine lactatepowder for solution

for external use

100mg,

0,1g plastic or glass bottle

Esco-Pharm LLC, Nor-

Norq, Mikoyan 13,

Yerevan

Republic of

ArmeniaD08AA01 12819

17.09.2013

17.09.2018OTC


Norq, Mikoyan 13,


Armenia

3687 Rixubis

nonacog gamma

(human blood

coagulation factor

IX)

powder and solvent

for solution for

injection

500IU,


5ml glass vial with

solvent (1), BaxJect II

(needle-less

reconstitution device) (1)

Baxalta Belgium

Manufacturing SA,

Boulevard Rene

Branquart 80, B-7860

Lessines-batch

releaser, secondary

packager, Baxalta US

Inc.,1700 Rancho

Conejo Boulevard,

Thousand Oaks, CA

91320 USA -bulk

manufacturer,

primary packager

Belgium B02BD04 1662925.04.2017

25.04.2022PoM

Baxalta Innovations

GmbH,

Industriestrasse 67, A-

1221 Vienna, Austria

809

3688 Rixubis

nonacog gamma

(human blood

coagulation factor

IX)

powder and solvent

for solution for

injection

250IU,


5ml glass vial with


(needle-less


Baxalta Belgium

Manufacturing SA,

Boulevard Rene


Lessines-batch

releaser, secondary


Inc.,1700 Rancho

Conejo Boulevard,

Thousand Oaks, CA

91320 USA -bulk

manufacturer,

primary packager for

Baxalta Innovations

GmbH,



Belgium B02BD04 1663025.04.2017

25.04.2022PoM

3689 Rixubis

nonacog gamma

(human blood

coagulation factor

IX)

powder and solvent

for solution for

injection

1000IU,


5ml glass vial with


(needle-less


Baxalta Belgium

Manufacturing SA,

Boulevard Rene


Lessines-batch

releaser, secondary


Inc.,1700 Rancho

Conejo Boulevard,

Thousand Oaks, CA

91320 USA -bulk

manufacturer,

primary packager

Belgium B02BD04 1663125.04.2017

25.04.2022PoM

Baxalta Innovations

GmbH,



810

3690 Rocaltrol calcitriol capsules

0,25mcg,


100(5x20)

Hoffmann-La Roche

Ltd.,

Grenzacherstrasse

124, 4070 Basel -

batch releaser

packager (Catalent

Germany Eberbach

GmbH,

Gammelsbacherstrass

e 2, D-69412

Eberbach, Germany -

bulk manufacturer)

(F. Hoffmann-La

Roche Ltd.,

Wurmisweg CH-4303

Kaiseraugst,

Switzerland -

packager)

Switzerland A11CC04 1387623.09.2014

23.09.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

3691 Rocephin ceftriaxonepowder for solution

for injection

1000mg,

glass vials (143/1x143/)

F. Hoffmann-La

Roche Ltd,

Wurmisweg, 4303

Kaiseraugst

Switzerland J01DD04 1212617.01.2013

17.01.2018PoM

Roche Pharma

(Schweiz) Ltd.,

Schoenmattstrasse 2

4153 Reinach,

Switzerland

3692 Rocephin

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for injection

1000mg,

glass vial (143/1x143/)

F.Hoffmann-La Roche

Ltd. Wurmisweg, CH-

4303 Kaiseraugst


25.04.2022PoM

F. Hoffmann-La

Roche Ltd.,


Basel, CH-4070,

Switzerland

3693Rocephin, with

solventceftriaxone

powder for solution

for injection

1000mg,

glass vial (1), 3,5ml

solvent in ampoule (1)

F. Hoffmann-La

Roche Ltd,

Wurmisweg, 4303

Kaiseraugst


17.01.2018PoM

Roche Pharma

(Schweiz) Ltd.,

Schoenmattstrasse 2

4153 Reinach,

Switzerland

811

3694 RociTRONN

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for injection1000mg, glass vial

Protech Biosystems


146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001

India J01DD04 1261721.06.2013

21.06.2018PoM

Protech Biosystems

Pvt. Ltd., Plot No

145-146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001,

India

3695 Roferon-A interferon alfa-2asolution for s/c

injection

3000000IU/0,5ml, 0,5ml

pre-filled sirynge and

needle

F.Hoffmann-La Roche

Ltd., Wurmisweg,

4303 Kaiseraugust

Switzerland L03AB04 1320620.12.2013

20.12.2018PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

3696 Rolenol closantelsolution for i/m or

s/c injection

50mg/ml,


Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19

Spain

QP52AG09

veterinary

drug

13004/128.04.2014

14.11.2018PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

3697 RopenTRONN

meropenem

(meropenem

trihydrate)

powder for solution

for i/v injection

500mg,

10ml glass vial (1)

Sanjivani Paranteral

Limited R-40, T.T.C.

Rabale, Thane-

Belapur Road, Navi

Mumbai Pin 400 701

India J01DH02 1215001.02.2013

01.02.2018PoM

S.P. Incomed Pvt.

Ltd., H-680, Palam

Extn.-1, New Delhi

110 045, India

3698 RopenTRONN

meropenem

(meropenem

trihydrate)

powder for solution

for i/v injection

1000mg,

20ml glass vial (1)



Rabale, Thane-

Belapur Road, Navi

Mumbai Pin 400 701

India J01DH02 1215101.02.2013

01.02.2018PoM

S.P. Incomed Pvt.

Ltd., H-680, Palam

Extn.-1, New Delhi

110 045, India

3699 Rosart

rosuvastatin

(rosuvastatin

calcium)

tablets film-coated

40mg,


28/4x7/, 30/3x10/,

90/9x10/)

Actavis Ltd., BLB 015,

BLB 016, Bulebel

Industrial Estate,

Zejtun, ZTN 3000

C10AA07 1608010.11.2016

10.11.2021PoM

"Actavis Group PTC

ehf",

Reykjavikurvegur 76-

78, IS-220

Hafnarfjordur,

Iceland

812

3700 Rosart

rosuvastatin

(rosuvastatin

calcium)

tablets film-coated

10mg,


28/4x7/, 30/3x10/,

90/9x10/)


BLB 016, Bulebel

Industrial Estate,

Zejtun, ZTN 3000

Malta C10AA07 1608110.11.2016

10.11.2021PoM

"Actavis Group PTC

ehf",


78, IS-220

Hafnarfjordur,

Iceland

3701 Rosart

rosuvastatin

(rosuvastatin

calcium)

tablets film-coated

20mg,


28/4x7/, 30/3x10/,

90/9x10/)


BLB 016, Bulebel

Industrial Estate,

Zejtun, ZTN 3000

Malta C10AA07 1608210.11.2016

10.11.2021PoM

"Actavis Group PTC

ehf",


78, IS-220

Hafnarfjordur,

Iceland

3702 Rosucard

rosuvastatin

(rosuvastatin

calcium)



Zentiva, k.s., U

kabelovny 130, 102 37

Praha 10, Dolni

Mecholupy

Czech Republic C10AA07 1276914.08.2013

14.08.2018PoM

Zentiva, k.s., U

kabelovny 130, 102

37 Praha 10, Dolni

Mecholupy, Czech

Republic

3703 Rosucard

rosuvastatin

(rosuvastatin

calcium)



Zentiva, k.s., U


Praha 10, Dolni

Mecholupy


14.08.2018PoM

Zentiva, k.s., U

kabelovny 130, 102

37 Praha 10, Dolni

Mecholupy, Czech

Republic

3704 Rosucard

rosuvastatin

(rosuvastatin

calcium)



Zentiva, k.s., U


Praha 10, Dolni

Mecholupy


17.09.2018PoM

Zentiva, k.s., U

kabelovny 130, 102

37 Praha 10, Dolni

Mecholupy, Czech

Republic

3705 Rosuliprosuvastatin

(rosuvastatin zinc)tablets film-coated

5mg,


28/4x7/, 56/8x7/)


PLC, 1165 Budapest,


120

Hungary C10AA07 1546102.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary

813



10mg,


28/4x7/, 56/8x7/)


PLC, 1165 Budapest,


120

Hungary C10AA07 1546202.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary



20mg,


28/4x7/, 56/8x7/)


PLC, 1165 Budapest,


120

Hungary C10AA07 1546302.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary



40mg,


28/4x7/, 56/8x7/)


PLC, 1165 Budapest,


120

Hungary C10AA07 1546402.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary



5mg,


28/4x7/, 56/8x7/)


PLC, 1165 Budapest,


120 -batch releaser,

packager, Egis


9900, Kormend,

Matyas Kiraly u. 65,

Hungary-bulk

manufacturer

Hungary C10AA07 1546502.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary



10mg,


28/4x7/, 56/8x7/)


PLC, 1165 Budapest,



packager, Egis


9900, Kormend,


Hungary-bulk

manufacturer

Hungary C10AA07 1546602.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary

814



20mg,


28/4x7/, 56/8x7/)


PLC, 1165 Budapest,



packager, Egis


9900, Kormend,


Hungary-bulk

manufacturer

Hungary C10AA07 1546702.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary



40mg,


28/4x7/, 56/8x7/)


PLC, 1165 Budapest,



packager, Egis


9900, Kormend,


Hungary-bulk

manufacturer

Hungary C10AA07 1546802.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary

3713 Rosulip Plus

rosuvastatin

(rosuvastatin zinc),

ezetimibe

capsules10mg+10mg,



PLC, 1165 Budapest,



packager, Egis


9900, Kormend,


Hungary- bulk

manufacturer

Hungary C10AA07 1536026.02.2016

26.02.2021PoM


PLC, 1106 Budapest,


Hungary

815

3714 Rosulip Plus

rosuvastatin


ezetimibe

capsules20mg+10mg,



PLC, 1165 Budapest,



packager, Egis


9900, Kormend,


Hungary- bulk

manufacturer

Hungary C10AA07 1536126.02.2016

26.02.2021PoM


PLC, 1106 Budapest,


Hungary

3715 Rosulip Plus

rosuvastatin


ezetimibe

capsules40mg+10mg,



PLC, 1165 Budapest,



packager, Egis


9900, Kormend,


Hungary- bulk

manufacturer

Hungary C10AA07 1536226.02.2016

26.02.2021PoM


PLC, 1106 Budapest,


Hungary

3716 Rosulip Plus

rosuvastatin


ezetimibe

capsules20mg+10mg,



PLC, 1165 Budapest,


120

Hungary C10AA07 1543402.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary

3717 Rosulip Plus

rosuvastatin


ezetimibe

capsules40mg+10mg,



PLC, 1165 Budapest,


120

Hungary C10AA07 1543502.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary

3718 Rosulip Plus

rosuvastatin


ezetimibe

capsules10mg+10mg,



PLC, 1165 Budapest,


120

Hungary C10AA07 1543602.04.2016

02.04.2021PoM


PLC, 1106 Budapest,


Hungary

816

3719Rosuvastatin

Sandoz

rosuvastatin

(rosuvastatin

calcium)



Lek Pharmaceuticals


57, 1526 Ljubljana-

bulk manufacturer,

batch releaser

(packager-Lek

Pharmaceuticals

d.d.,Trimlini 2D,

Lendava, 9220,

Slovenia)

Slovenia C10AA07 1580220.07.2016

20.07.2021PoM

Sandoz


Verovskova Str. 57,

1526 Ljubljana,

Slovenia

3720Rosuvastatin

Sandoz

rosuvastatin

(rosuvastatin

calcium)



Lek Pharmaceuticals


57, 1526 Ljubljana-

bulk manufacturer,

batch releaser

(packager-Lek

Pharmaceuticals

d.d.,Trimlini 2D,

Lendava, 9220,

Slovenia)

Slovenia C10AA07 1580320.07.2016

20.07.2021PoM

Sandoz


Verovskova Str. 57,

1526 Ljubljana,

Slovenia

3721 Rotarixhuman rotavirus

vaccine livesuspension oral

not less than

10^6CCID^50/dose; (50)

plastic tube 1.5ml (1 dose)

GlaxoSmithKline




releaser,

GlaxoSmithKline



Fleming, 20 1300

Wavre, Belgium-

(bulk manufacturer,

packager

BelgiumJ07BH;

vaccine16854

10.07.2017

10.07.2022PoM

GlaxoSmithKline



1330 Rixensart,

Belgium

817

3722 RotaTeq

rotavirus type G1,

rotavirus type G2,

rotavirus type G3,

rotavirus type G4,

rotavirus type

P1A[8]

solution oral

not less than

2,2x106IU+not less than



2x106IU+not less than

2,3x106IU, 2ml plastic

tube (1, 10)

Merck Sharp &

Dohme Corp.,

Sumneytown Pike

P.O. Box 4, West

Point, PA, 19486-

0004, USA - dosage

form manufacturer,

packager (Merck

Sharp & Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -batch

releaser)

the NetherlandsJ07BH02

vaccine12593/1

27.09.2013

21.06.2018PoM

Merck Sharp &

Dohme Idea AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

3723 Rovamycine spiramycin tablets film-coated3000000IU,


Famar Lyon, 29

Avenue Charles de

Gaulle, 69230 Saint

Genis Laval

France J01FA02 1577104.07.2016

04.07.2021PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain

Rolland, 75014 Paris,

France

3724

Rowachol Gastro-

resistant Capsules,

Soft

a-pinene, b-pinene,

menthol,

menthone, borneol,

camphene, cineole

capsules gastro-

resistant, soft

13,6mg+3,4mg+

32mg+6mg+5mg+

5mg+2mg,


Rowa Pharmaceuticals Ltd.

(Newtown, Bantry, Co.

Cork) - batch releaser

(dosage form manufacturer

- SC SwissCaps Romania

SRL /Romania, No. 1 Carol

I Street, Comuna Cornu,

Jud. Prahova 107180,

Romania/) (bulk

manufacturer - Rowa

Pharmaceuticals Ltd.

/Newtown, Bantry, Co.

Cork, Ireland/) (primary

packager - TD Packaging

Ltd., Groundwell Industrial

Estate /Unit 6, Stephenson

Road, Swindon, Wiltshire

SN25 5AX, UK/)

(secondary packager - JSC

Norfachema, /Vytauto g. 6,

LT-55175 Jonava,

Lithuania/)

IrelandA05AX;

herbal drug12950

28.10.2013

28.10.2018PoM

Rowa


(Newtown, Bantry,

Co. Cork, Ireland)

818

3725

Rowachol Gastro-

resistant Capsules,

Soft

a-pinene, b-pinene,

menthol,

menthone, borneol,

camphene, cineole

capsules gastro-

resistant, soft

13,6mg+3,4mg+

32mg+6mg+5mg+

5mg+2mg,


Rowa


Newtown, Bantry,

Co. Cork - batch

releaser (SC Swiss

Caps Romania SRL,

No. 1 Carol I Street,

Comuna Cornu, Jud.

Prahova 107180,

Romania - bulk

manufacturer) (MPF

B.V., Neptunus 12,

Heerenveen 8448 CN,

the Netherlands -

primary packager)

(JSC Norfachema,

Vytauto g. 6, LT-

55175 Jonava,

Lithuania - secondary

packager)

IrelandA05AX

herbal drug 13910

29.10.2014

29.10.2019PoM

Rowa


Newtown, Bantry,

Co. Cork, Ireland

3726

Rowatinex Gastro-

resistant Capsules,

Soft

a-pinene, b-pinene,

camphene, borneol,

anethol, fenchone,

cineole

capsules gastro-

resistant, soft

24,8mg+6,2mg+

15mg+10mg+4mg+4mg+3

mg,


Rowa Pharmaceuticals Ltd.

(Newtown, Bantry, Co.

Cork) - batch releaser

(dosage form manufacturer

- SC SwissCaps Romania

SRL, /Romania, No. 1 Carol

I Street, Comuna Cornu,

Jud. Prahova 107180,

Romania/) (bulk

manufacturer - Rowa


/Newtown, Bantry, Co.

Cork, Ireland/) (primary

packager - TD Packaging

Ltd., Groundwell Industrial

Estate /Unit 6, Stephenson

Road, Swindon, Wiltshire

SN25 5AX, UK/)

(secondary packager - JSC

Norfachema /Vytauto g. 6,

LT-55175 Jonava,

Lithuania/)

IrelandG04BC;

herbal drug12949

28.10.2013

28.10.2018PoM

Rowa


(Newtown, Bantry,

Co. Cork, Ireland)

819

3727

Rowatinex Gastro-

resistant Capsules,

Soft

a-pinene, b-pinene,

camphene, borneol,

anethol, fenchone,

cineole

capsules gastro-

resistant, soft

24,8mg+6,2mg+

15mg+10mg+4mg+4mg+3

mg,


Rowa


Newtown, Bantry,

Co. Cork - batch

releaser (SC Swiss

Caps Romania SRL,

No. 1 Carol I Street,

Comuna Cornu, Jud.

Prahova 107180,

Romania - bulk

manufacturer) (MPF

B.V., Neptunus 12,

Heerenveen 8448 CN,

the Netherlands -

primary packager)

(JSC Norfachema,

Vytauto g. 6, LT-

55175 Jonava,

Lithuania - secondary

packager)

IrelandG04BC

herbal drug 13911

29.10.2014

29.10.2019PoM

Rowa


Newtown, Bantry,

Co. Cork, Ireland

3728 Roxera

rosuvastatin

(rosuvastatin

calcium)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA07 1308009.12.2013

09.12.2018PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3729 Roxera

rosuvastatin

(rosuvastatin

calcium)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA07 1308109.12.2013

09.12.2018PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3730 Roxera

rosuvastatin

(rosuvastatin

calcium)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA07 1308209.12.2013

09.12.2018PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3731 Roxera

rosuvastatin

(rosuvastatin

calcium)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA07 1357510.06.2014

10.06.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

820

3732Roxithromycin

Sandoz 150mgroxithromycin tablets film-coated

150mg,


S.C. Sandoz S.R.L., str.

Livezeni nr. 7A,

540472, Targu Mures

Romania J01FA06 1533116.02.2016

16.02.2021PoM

Sandoz


Verovskova Str. 57,

1526 Ljubljana,

Slovenia

3733 Rozamet metronidazolecream for external

use

10mg/g,

25g aluminium tube

JADRAN- GALENSKI

LABORATORIJ d.d.,

Svilno 20, 51000

Rijeka

Croatia D06BX01 1593024.08.2016

24.08.2021PoM

JADRAN- GALENSKI

LABORATORIJ d.d.,

Svilno 20, 51000

Rijeka, Croatia

3734 Rozim-10

rosuvastatin

(rosuvastatin

calcium)




B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India C10AA07 1493320.10.2015

20.10.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

3735 Rozim-20

rosuvastatin

(rosuvastatin

calcium)




B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India C10AA07 1475403.08.2015

03.08.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

3736 RubiDol

thiamine (thiamine

hydrochloride),

pyridoxine

(pyridoxine

hydrochloride),

cyanocobalamin,


hydrochloride)


100mg/2ml+ 100mg/2ml+

1mg/2ml+ 20mg/2ml,

2ml glass vials (5)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaA11DB 12809

05.10.2013

05.10.2018PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

821

3737 Rulid roxithromycin tablets film-coated150mg,


Sanofi Winthrop

Industrie, 56, Rout de

Choisy au Bac, 60205

Compiegne

France J01FA06 1340714.04.2014

14.04.2019PoM

Sanofi-Aventis

France, 1-13

boulevard Romain


France

3738 Rutacid hydrotalcite tablets chewable

500mg,


60/6x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A02AD04 1337104.04.2014

04.04.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3739 Rycardon irbesartan tablets film-coated150mg,


Delorbis


17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia (bulk

manufacturer -

Zhejiang Huahai

Pharmaceutical Co

Ltd, Xunqiao, Linhai

317024, Zhejiang,

China)

Cyprus C09CA04 12197/102.12.2014

31.01.2018PoM

Delorbis


17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia, Cyprus

3740 Rycardon irbesartan tablets film-coated300mg,


Delorbis


17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia (bulk

manufacturer -

Zhejiang Huahai

Pharmaceutical Co

Ltd, Xunqiao,Linhai

317024, Zhejiang,

China)

Cyprus C09CA04 12198/102.12.2014

31.01.2018PoM

Delorbis


17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia, Cyprus

822

3741Ryzodeg

FlexTouch

insulin degludec

(70%),insulin aspart

(30%)

solution for injection100U/ml,

3ml pre-filled pens (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd-batch

releaser, bulk

manufacturer,

primary packager,

Novo Nordisk A/S,

Brennum Park,

Hillerod,3400,

Denmark- secondary

packager

Denmark A10AD06 1674505.06.2017

05.06.2022PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

3742 Safocid

I-fluconazole, II-

azithromycin

(azithromycin

dihydrate), III-

secnidazole

I-tablets, II-film-

coated tablets, III-

film-coated tablets

150mg+1000mg+ 1000mg,

in blister (4/1x4(1-I+1-

II+2-III)/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye highway -

batch releaser,

secondary packager,

Lyka Labs Limited, T-

139, MIDC Industrial

Estate,Tarapur,

District Thane

401506, India-bulk

manufacturer,

primary packager

Russia 15005/102.05.2016

02.12.2020PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

3743 Salbutamedsalbutamol

(salbutamol sulfate)syrup

0,4mg/ml,


measuring cup

Medpharma Pharm.

& Chem. Ind.,s LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

EmiratesR03CC02 13628

27.06.2014

27.06.2019PoM

Medpharma Pharm.

& Chem. Ind.,s LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

3744 Salbutamolsalbutamol

(salbutamol sulfate)tablets

2mg,

in blister (24)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaR03CC02 13263

10.03.2014

10.03.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

823


(salbutamol sulfate)

aerosol for inhalation

dosed

100mcg/dose, aluminium

container with inhaler

(200 doses)

Glaxo Wellcome

Production, Zone

Industrielle N 2, 23


Evreux

France R03AC02 1399926.11.2014

26.11.2019PoM

Laboratoire

GlaxoSmithKline, 100

route de Versallies

78163 Marly-Le-Roi

Cedex, France



2mg,


Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw -

batch releaser,

Pharmaceutical

Works Polpharma

S.A., ul.

Szypowskiego 1,

Nowa Deba, 39-460,

Poland -bulk

manufacturer,

primary and

secondary packager

Poland R03CC02 14904/111.01.2016

24.09.2020PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw,

Poland



4mg,


glass vial (30)

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw -

batch releaser,

Pharmaceutical

Works Polpharma

S.A., ul.

Szypowskiego 1,

Nowa Deba, 39-460,

Poland -bulk

manufacturer,

primary and

secondary packager

Poland R03CC02 14905/111.01.2016

24.09.2020PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw,

Poland

824



aerosol for

inhalation, dosed

100mcg/dose,

200 doses (12ml)

aluminium container

with pump dispenser

Binnopharm JSC, 3,

building 1,

Konstruktora

Guskova str.,

Zelenograd, Moscow,

124460

Russia R03AC02 1620808.12.2016

08.12.2021PoM

Binnopharm JSC, 3,

building 1,

Konstruktora

Guskova str.,

Zelenograd, Moscow,

124460, Russia

3749Salbutamol

Sopharma

salbutamol


2mg/5ml,


bottle

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria R03CC02 1218001.02.2013

01.02.2018PoM

Sopharma JSC, str.

Iliensko shosse 16,


3750Salbutamol

Sopharma

salbutamol


2mg/5ml,


bottle and measuring cup

Sopharma JSC,

Vrabevo vlg. 5660,

district of Lovetch

Bulgaria R03CC02 1713207.11.2017

07.11.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,


3751 Salbutamol-Altaysalbutamol


suspension,

pressurised

inhalation

100mcg/ dose,

11g (300 doses)

aluminium container

with pump dispenser




69

Russia R03AC02 1567608.06.2016

08.06.2021PoM




69, Russia

3752 Salin sodium chloride spray nasal6,5mg/ml,

30ml plastic bottle

Istituto de Angeli

S.R.L., Loc. Prulli,

103/C 50066 Reggello,

Firenze

Italy R01AX10 1693701.09.2017

01.09.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

825

3753 Salipan 1% dexpanthenol spray nasal

10mg/ml,

10ml (100 dose) glass or

plastic vial with pump

dispenser, 15ml (150

dose) glass or plastic vial

with pump dispenser,



dispenser

Arsanit Ltd, 110

Yerevanyan str.,

Masis - batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,


Armenia - primary

packager, dosage form

manufacturer

Republic of

Armenia R01AX10 16910

08.08.2017

08.08.2022OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

3754 Salipan 5% dexpanthenol spray nasal

50mg/ml,

10ml (100 doses),15ml

(150 doses), 30ml (300

doses) glass or plastic vial

with pump dispenser

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,


Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AX10 17010

26.09.2017

26.09.2022OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

3755 Salivin sodium chloride spray nasal

6,5mg/ml,

10ml, 15ml, 25ml and

30ml glass or plastic vial

with pump dispencer

Arsanit Ltd, 110

Yerevanyan str.,


secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,


Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaS01XA03 16503

17.03.2017

17.03.2022OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

826

3756 Salivin sodium chloride drops nasal

6,5mg/ml,

5ml and 10ml plastic vial-

dropper

Arsanit Ltd, 110

Yerevanyan str.,


secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,


Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaS01AX03 16504

17.03.2017

17.03.2022OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

3757 Samprostsamprost (extract of

prostate)

powder lyophilized


injection

5mg,

glass vials (10)

"Samson-Med" LLC,

Moscow highway, 13,

Saint Petersburg,

196158

Russia G04BX 1583220.07.2016

20.07.2021PoM

"Samson-Med" LLC,

Moscow highway, 13,

Saint Petersburg,

196158, Russia

3758 Sanagel

methyluracil,


hydrochloride),

silbiol

gel for external use30mg/g+20mg/g+ 10mg/g,

15g aluminium tube

"LMP" Ltd., 1,


LV-1009

Latvia D03AX 1628119.12.2016

19.12.2021OTC

"LMP" Ltd., 1,


LV-1009, Latvia

3759 Sandimmun Neoral ciclosporin capsules soft50mg,


Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein-batch

releaser, packager,

Catalent Germany

Eberbach GmbH,

Gammelsbacher Str.

2, 69412 Eberbach,

Germany -bulk

manufacturer

Switzerland L04AD01 1653928.03.2017

28.03.2022PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

827



Novartis Pharma

Stein AG,


4332 Stein-batch

releaser, packager,

Catalent Germany

Eberbach GmbH,

Gammelsbacher Str.

2, 69412 Eberbach,

Germany -bulk

manufacturer


28.03.2022PoM

Novartis Pharma AG,


Basel, Switzerland



Novartis Pharma

Stein AG,


4332 Stein-batch

releaser, packager,

Catalent Germany

Eberbach GmbH,

Gammelsbacher Str.

2, 69412 Eberbach,

Germany -bulk

manufacturer


28.03.2022PoM

Novartis Pharma AG,


Basel, Switzerland

3762 Sandostatinoctreotide

(octreotide acetate)solution for injection

0,05mg/ml,

1ml ampoules (5)

Novartis Pharma

Stein AG,


4332 Stein

Switzerland H01CB02 1252029.05.2013

29.05.2018PoM

Novartis Pharma AG,

Switzerland 56,

Lichtstrasse, 4056

Basel, Switzerland



0,1mg/ml,

1ml ampoules (5)

Novartis Pharma

Stein AG,


4332 Stein


29.05.2018PoM

Novartis Pharma AG,

Switzerland 56,

Lichtstrasse, 4056

Basel, Switzerland



0,05mg/ml,

1ml ampoules (5)

Novartis Pharma

Stein AG,


4332 Stein


12.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

828



0,1mg/ml,

1ml ampoules (5)

Novartis Pharma

Stein AG,


4332 Stein


12.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

3766 Sandostatin LARoctreotide

(octreotide acetate)

powder for

suspension for

injection

20mg,


pre-filled syringe, adapter

and needle

Novartis Pharma

Stein AG,


4332 Stein-batch

releaser, secondary

packager, Sandoz

GmbH, Plant

Schaftenau,


A-6336 Langkampfen,

Austria-bulk

manufacturer,

primary packager


03.08.2020PoM

Novartis Pharma AG,


Basel, Switzerland



powder for

suspension for

injection

30mg,



and needle

Novartis Pharma

Stein AG,


4332 Stein-batch

releaser, secondary

packager, Sandoz

GmbH, Plant

Schaftenau,


A-6336 Langkampfen,

Austria-bulk

manufacturer,

primary packager


03.08.2020PoM

Novartis Pharma AG,


Basel, Switzerland

829



powder for

suspension for

injection

10mg,



and needle

Novartis Pharma

Stein AG,


4332 Stein-batch

releaser, secondary

packager, Sandoz

GmbH, Plant

Schaftenau,


A-6336 Langkampfen,

Austria-bulk

manufacturer,

primary packager


03.08.2020PoM

Novartis Pharma AG,


Basel, Switzerland

3769 Sanorin

naphazoline

(naphazoline

nitrate)

drops nasal

(emulsion)

1mg/ml,

10ml glass bottle

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p. 305,

747 70 Opava-

Komarov, Czech

Republic

Czech Republic R01AA08 12999/111.07.2016

28.10.2018OTC

Xantis Pharma

Limited, Kitiou, 5 1st

floor, Flat/Office 101,

1071 Nicosia, Cyprus

3770 Sanorin

naphazoline

(naphazoline

nitrate)

spray nasal

1mg/ml,


pump dispenser

TEVA Czech

Industries s.r.o.,

Ostravska 29/305, 747

70 Opava-Komarov

Czech Republic R01AA08 1619308.12.2016

08.12.2021OTC

Xantis Pharma

Limited, Office 101, 5

Kitiou street, 1071

Nicosia, Cyprus

3771 Santol

naphazoline

(naphazoline

hydrochloride)

drops eye0,3mg/ml,


Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01GA01 15294

04.02.2016

04.02.2021OTC

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

3772 Sartuzin

fluoxetine

(fluoxetine

hydrochloride)

capsules hard

20mg,

in blister

(12/3x4/, 28/4x7/)

Help S.A. (Pedini


45501)

Greece N06AB03 1290107.10.2013

07.10.2018PoM

Help S.A. (10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece)

830

3773 Savarix gel

heparin (heparin

sodium),

benzocaine, horse

chestnut seed

extract

gel

500IU/g+10mg/g+

50mg/g,

50g aluminium tube

Pharmaceutical

Manufacturing

Enterprise "GEMI", 05-

480 Karczew,

Mickiewicza 36 str.

Poland C05BA53 1646306.03.2017

06.03.2022OTC

Pharmaceutical

Manufacturing

Enterprise "GEMI",

05-480 Karczew,

Mickiewicza 36 str.,

Poland

3774Scandonest 2%

Special

mepivacaine

(mepivacaine

hydrochloride),

adrenaline


20mg/ml+ 10mcg/ml,

1,8ml cartridges

(50/5x10/)

Septodont, 58 rue du

Pont de Creteil,

94100 Saint- Maur-

des- Fosses

France N01BB53 1417516.01.2015

16.01.2020PoM


Pont de Creteil,

94100 Saint- Maur-

des- Fosses, France

3775Scanlux 300mg

I/mliopamidol solution for injection

612mg/ml (300mg I/ml),

50ml, 100ml, 200ml glass

vial (10)

Sanochemia

Pharmazeutika AG,

Landeggerstrasse 7, A-

2491 Neufeld/Leitha -


manufacturer,

primary packager,

Sanochemia

Pharmazeutika AG,

Landeggerstrasse 33,

A-2491

Neufeld/Leitha,

Austria -secondary

packager

Austria V08AB04 1429419.03.2015

19.03.2020PoM

Sanochemia

Pharmazeutika AG,

Boltzmanngasse 11,

1090 Wien, Austria

831

3776Scanlux 370mg

I/mliopamidol solution for injection

755mg/ml (370mg I/ml),


bottle (10)

Sanochemia

Pharmazeutika AG,

Landeggerstrasse 7, A-

2491 Neufeld/Leitha -


manufacturer,

primary packager,

Sanochemia

Pharmazeutika AG,

Landeggerstrasse 33,

A-2491

Neufeld/Leitha,

Austria -secondary

packager

Austria V08AB04 1429319.03.2015

19.03.2020PoM

Sanochemia

Pharmazeutika AG,

Boltzmanngasse 11,

1090 Wien, Austria

3777 Sebivo telbivudine tablets film-coated600mg,


Novartis Pharma

Stein AG,


4332 Stein

Switzerland J05AF11 1332210.03.2014

10.03.2019PoM

Novartis Pharma AG,


Basel, Switzerland

3778 Sedalgin Plus

metamizole

(metamizole

sodium), caffeine,

thiamine

hydrochloride

tablets

500mg+50mg+ 38,75mg,


20/2x10/, 50/5x10/),


Balkanpharma-

Dupnitsa AD,

str."Samokovsko


2600

Bulgaria N02BB52 1259421.06.2013

21.06.2018OTC

Balkanpharma-

Dupnitsa AD

(ACTAVIS GROUP),

str. "Samokovsko


2600

3779 Sedarex risperidone tablets coated1mg,


GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia N05AX08 1463903.07.2015

03.07.2020PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala




GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia N05AX08 1464003.07.2015

03.07.2020PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


832



GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia N05AX08 1464103.07.2015

03.07.2020PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


3782 Sedative drops

valerian tincture,

hawthorn tincture,

motherwort

tincture

drops for oral use

17ml/50ml+

16,5ml/50ml+

16,5ml/50ml,

50ml glass bottle

Open Joint Stock

Company, Borisovskiy

zavod Medicinskikh

Preparatov, 64/27,

Chapayev str., Borisov

222120, Minsk oblast

Belarus N05CX 1325324.02.2014

24.02.2019OTC

Open Joint Stock

Company,

Borisovskiy zavod

Medicinskikh

Preparatov, 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus

3783 Sedavit

herbal thick extract,

vitamin B6, vitamin

PP



Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

UkraineN05CM;

herbal drug17161

07.11.2017

07.11.2022OTC

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

3784Sedropor 150mg

film-coated tablets

ibandronic acid

(ibandronic acid

sodium

monohydrate)


in blister (1, 3)

Pharmathen S.A.,


Pallini, Attiki

Greece M05BA06 13258/120.05.2014

24.02.2019PoM

Pharmathen S.A.,



3785 Seebri Breezhaler

glycopyrronium

(glycopyrronium

bromide)

capsules hard with

powder for

inhalation

0,05mg,


inhaller

Novartis Pharma

Stein AG,


4332 Stein

Switzerland R03BB06 1286417.09.2013

17.09.2018PoM

Novartis Pharma AG,

Switzerland 35,

Lichtstrasse, 4056

Basel, Switzerland

3786 Senadexin sennosides A and B tablets70mg,

in blister (10), in strip (10)

'Lubnypharm' PJSC,

37500, Poltava region,

Lubny, Petrovskogo

str. 16

Ukraine A06AB06 1550619.04.2016

19.04.2021OTC

Lubnypharm' PJSC,


Lubny, Petrovskogo

str. 16, Ukraine

833

3787Senadexin-

Zdorovyesennosides A, B tablets

70mg,


Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

UkraineA06AB06;

herbal drug16617

25.04.2017

25.04.2022OTC

Pharmaceutical

Company "Zdorovye"



Ukraine

3788 Sentorlosartan (losartan


50mg,


30/3x10/)

Gedeon Richter



5 , Grodzisk


batch releaser

(Gedeon Richter

Poland Sp.z o.o.,

ul.Graniczna

35,Grodzisk

Mazowiecki, 05-825,

Poland - bulk

manufacturer,

packager)

Poland C09CA01 1346006.05.2014

06.05.2019PoM

Gedeon Richter


21, 1103 Budapest,

Hungary

3789 Sentorlosartan (losartan


100mg,


30/3x10/)

Gedeon Richter



5 , Grodzisk


batch releaser

(Gedeon Richter

Poland Sp.z o.o.,

ul.Graniczna

35,Grodzisk

Mazowiecki, 05-825,

Poland - bulk

manufacturer,

packager)

Poland C09CA01 1346106.05.2014

06.05.2019PoM

Gedeon Richter


21, 1103 Budapest,

Hungary

834

3790 Sepol fluconazole capsules150mg,

in blister (1)



0198 Tbilisi-batch

releaser, packager,

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia-bulk

manufacturer

Georgia J02AC01 1550319.04.2016

19.04.2021PoM




3791Septanazal for

adults

xylometazoline

(xylometazoline

hydrochloride),

dexpanthenol

spray nasal

1mg/ml+50mg/ml, 10ml

(100 doses) plastic

container with pump

dispenser

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia R01AB 1475903.08.2015

03.08.2020OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3792Septanazal for

children

xylometazoline

(xylometazoline

hydrochloride),

dexpanthenol

spray nasal

0,5mg/ml+ 50mg/ml,

10ml (100 doses) plastic

container with pump

dispenser

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia R01AB 1476003.08.2015

03.08.2020OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3793

Septanest with

adrenaline

1/100000

articaine (articaine

hydrochloride),

adrenaline

(adrenaline

bitartrate)


40mg/ml+ 10mcg/ml,

1,7ml cartridges

(50/5x10/)


Pont de Creteil,

94100 Saint- Maur-

des- Fosses

France N01BB58 1417616.01.2015

16.01.2020PoM


Pont de Creteil,

94100 Saint- Maur-

des- Fosses, France

3794Septoaqua for

adults

sodium chloride,

magnesium

sulphate

heptahydrate,

magnesium

chloride

hexahydrate,

calcium chloride

dihydrate, sodium

hydrogen carbonate

spray nasal

8.8mg/ml+ 2.5mg/ml+

1.8mg/ml+ 0.5mg/ml+

0.1mg/ml,

30ml (300 doses /1 dose-

100mg/) plastic container

with pump dispenser

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia R01AX10 1464903.07.2015

03.07.2020OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

835

3795Septoaqua for

children

sodium chloride,

magnesium

sulphate

heptahydrate,

magnesium

chloride

hexahydrate,

calcium chloride

dihydrate, sodium

hydrogen carbonate

spray nasal

8.8mg/ml+ 2.5mg/ml+

1.8mg/ml+ 0.5mg/ml+

0.1mg/ml,

30ml (667 doses /1 dose-

45mg/) plastic container

with pump dispenser

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia R01AX10 1465003.07.2015

03.07.2020OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3796Septolete D

menthol

benzalkonium

chloridepastilles

1mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

KRKA d.d., Novo

mesto, Ulica Rada

Pusenjaka 10,

Ljutomer, 9240,

Slovenia-bulk

manufacturer,

packager

Slovenia R02AA16 1618423.11.2016

23.11.2021OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3797 Septolete mentholbenzalkonium

chloridelozenges

1mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch


Novo mesto, Ulica

Rada Pusenjaka 10,

Ljutomer, 9240,

Slovenia-bulk

manufacturer,

packager

Slovenia R02AA16 1654203.04.2017

03.04.2022OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

836

3798 Septolete Neo

cetylpyridinium

chloride

(cetylpyridinium

chloride

monohydrate)

lozenges with cherry

flavour

1,2mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch

releaser, secondary


manufacturer,

primary packager -

KRKA d.d., Novo

mesto, Ulica Rada

Pusenjaka 10,

Ljutomer, 9240,

Slovenia)

Slovenia R02AA06 1318910.01.2014

10.01.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3799 Septolete Neo

cetylpyridinium

chloride

(cetylpyridinium

chloride

monohydrate)

lozenges with apple

flavour

1,2mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch

releaser, secondary


manufacturer,

primary packager -

KRKA d.d., Novo

mesto, Ulica Rada

Pusenjaka 10,

Ljutomer, 9240,

Slovenia)

Slovenia R02AA06 1319010.01.2014

10.01.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3800 Septolete Neo

cetylpyridinium

chloride

(cetylpyridinium

chloride

monohydrate)

lozenges with lemon

flavour

1,2mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch

releaser, secondary


manufacturer,

primary packager -

KRKA d.d., Novo

mesto, Ulica Rada

Pusenjaka 10,

Ljutomer, 9240,

Slovenia)

Slovenia R02AA06 1319110.01.2014

10.01.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

837

3801 Septolete plus

cetylpyridinium

(cetylpyridinium

chloride),

benzocaine

spray2mg/ml+10mg/ml, 30ml


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia R02AA06 1327804.03.2014

04.03.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3802Septolete plus

honey and lime

benzocaine,

cetylpyridinium

chloride

lozenges5mg+1mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch


Novo mesto, Ulica

Rada Pusenjaka 10,

Ljutomer, 9240,

Slovenia-bulk

manufacturer,

packager

Slovenia R02AX 1650217.03.2017

17.03.2022OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3803Septolete plus

menthol

cetylpyridinium

(cetylpyridinium

chloride),

benzocaine

pastilles1mg+5mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch


Novo mesto, Ulica

Rada Pusenjaka 10,

Ljutomer, 9240,

Slovenia-bulk

manufacturer,

packager

Slovenia R02AA20 1571022.06.2016

22.06.2021OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3804 Septolete total

benzydamine

(benzydamine

hydrochloride),

cetylpyridinium

(cetylpyridinium

chloride)

spray for local use

1,5mg/ml+5mg/ml,

30ml(250 dose) plastic

container with pump

dispenser

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia R02AA20 1581120.07.2016

20.07.2021OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

838

3805 Septolete total

benzydamine

(benzydamine

hydrochloride),

cetylpyridinium

chloride

pastilles

3mg+1mg,

in blister (8/1x8/, 16/2x8/,

24/3x8/, 32/4x8/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo


KRKA d.d., Novo

mesto, Ulica Rada

Pusenjaka 10,

Ljutomer, 9240,

Slovenia-bulk

manufacturer,

packager

Slovenia R02AA20 1602617.10.2016

17.10.2021OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3806Septrin Paediatric

Suspension

trimethoprim,

sulfamethoxazolesuspension


glass bottle and double-

ended measuring spoon

(2,5ml/5ml)

Aspen Bad Oldesloe

GmbH,

Industriestrasse 32-36,

23843 Bad Oldasloe

Germany J01EE01 13415/111.04.2016

14.04.2019PoM

Aspen Pharma

Trading Limited,

3016 Lake Drive,

Citywest Business

Campus, Dublin 24,

Ireland

3807Seretide

Accuhaler/ Diskus

salmeterol

(salmeterol

xinafoate),

fluticasone

(fluticasone

propionate)

powder for

inhalation

50mcg+100mcg, plastic

inhaler disk (60 doses)

Glaxo Wellcome

Production, Zone



Evreux

France R03AK06 1451915.05.2015

15.05.2020PoM

Laboratoire


route de Versallies

78163 Marly-Le-Roi

Cedex, France

3808Seretide

Accuhaler/ Diskus

salmeterol

(salmeterol

xinafoate),

fluticasone

(fluticasone

propionate)

powder for

inhalation



Glaxo Wellcome

Production, Zone



Evreux

France R03AK06 1452015.05.2015

15.05.2020PoM

Laboratoire


route de Versallies

78163 Marly-Le-Roi

Cedex, France

3809Seretide

Accuhaler/ Diskus

salmeterol

(salmeterol

xinafoate),

fluticasone

(fluticasone

propionate)

powder for

inhalation



Glaxo Wellcome

Production, Zone



Evreux

France R03AK06 1452115.05.2015

15.05.2020PoM

Laboratoire


route de Versallies

78163 Marly-Le-Roi

Cedex, France

839

3810Seretide

Accuhaler/Diskus

salmeterol

(salmeterol

xinafoate),

fluticasone

(fluticasone

propionate)

powder for

inhalation



Glaxo Operations UK

Ltd, Priory Street,

Ware, Hertfordshire

SG12 0DJ

UK R03AK06 1431609.03.2015

09.03.2020PoM

Glaxo Operations UK

Ltd, 980 Great West

Road, Brentford,

Middlesex, TW8 9GS,

UK

3811Seretide

Accuhaler/Diskus

salmeterol

(salmeterol

xinafoate),

fluticasone

(fluticasone

propionate)

powder for

inhalation



Glaxo Operations UK

Ltd, Priory Street,

Ware, Hertfordshire

SG12 0DJ

UK R03AK06 1431709.03.2015

09.03.2020PoM

Glaxo Operations UK

Ltd, 980 Great West

Road, Brentford,

Middlesex, TW8 9GS,

UK

3812 Seretide Evohaler

salmeterol

(salmeterol

xinafoate),

fluticasone

(fluticasone

propionate)

aerosol for inhalation

25mcg/dose+

250mcg/dose,

120 doses in aluminium

container with pump

dispenser

Glaxo Wellcome

Production, Zone

Industrielle No. 2, 23


Evreux Cedex 9

France R03AK06 1350530.05.2014

30.05.2019PoM

Laboratoire


route de Versallies

78163 Marly-Le-Roi

Cedex, France

3813 Sermion nicergoline tablets film-coated30mg,


Pfizer Italia S.r.l.

Localita Marino del

Tronto, 63100 Ascoli

Piceno

Italy C04AE02 1332417.03.2014

17.03.2019PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd Street, New

York, 10017, USA

3814 Sermion nicergoline tablets coated5mg,


Pfizer Italia S.r.l.

Localita Marino del

Tronto, 63100 Ascoli

Piceno

Italy C04AE02 1430603.03.2015

03.03.2020PoM

Pfizer H.C.P.

Corporation, 235,


York, 10017, USA

3815 Sermion nicergoline

powder lyophilized

for solution for

injection

4mg,

glass vials (4) and 4ml

solvent in ampoules (4)


Viale Pasteur, 10

20014 Nerviano,

Milan

Italy C04AE02 1430703.03.2015

03.03.2020PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

840

3816 Sertazol

sertaconazole

(sertaconazole

nitrate)

suppositories vaginal 300mg; (1)

"Rubicon" LLC, 62B,

M. Gorky street,

210002, Vitebsk

Belarus D01AC14 1618123.11.2016

23.11.2021PoM

"Rubicon" LLC, 62B,

M. Gorky street,

210002, Vitebsk,

Belarus

3817 Sevoflurane sevoflurane liquid for inhalation100%,

250ml glass bottle

Piramal Enterprises

Limited, Sy.No.7-70,

70/1 & 70/2, Digwal

Village, Kohir

Mandal, Sangareddy

District - 502 321,

Telangana

India N01AB08 1682410.07.2017

10.07.2022PoM

Piramal Enterprises

Limited, Piramal

Towers, Ganpatrao

Kadam Marg, Lower

Parel, Mumbai-

400013, India

3818 Sevoran sevofluran liquid for inhalation100%,


Aesica Queenborough

Limited,

Queenborough Kent

ME 11 5EL

UK N01AB08 1607728.10.2016

28.10.2021PoM

AbbVie

Biopharmaceuticals

GmbH, Neuhofstrasse

23, Postfach 6341

Baar, Switzerland

3819 Sibason diazepam solution for injection

5mg/ml,

2ml ampoules,


KPE Zdorovye

narodu" LLC,

Melnikova str., 41,

Kharkov, 61002

Ukraine N05BA01 1237219.04.2013

19.04.2018PoM/UC

"KPE" Zdorovye

narodu" LLC, 61013,

Kharkov,Sevchenko

str. 22, Ukraine

3820 Signifor

pasireotide

(pasireotide

diaspartate)

solution for injection0,9mg/ml,

1ml ampoules (6)

Novartis Pharma

Stein AG,


4332 Stein


25.03.2020PoM

Novartis Pharma AG,


Basel, Switzerland

3821 Signifor

pasireotide

(pasireotide

diaspartate)


1ml ampoules (6)

Novartis Pharma

Stein AG,


4332 Stein


25.03.2020PoM

Novartis Pharma AG,


Basel, Switzerland

841

3822 Signifor

pasireotide

(pasireotide

diaspartate)


1ml ampoules (6)

Novartis Pharma

Stein AG,


4332 Stein


25.03.2020PoM

Novartis Pharma AG,


Basel, Switzerland

3823

Sildenafil Accord

100mg Film coated

Tablets

sildenafil (sildenafil

citrate)tablets film-coated

100mg,

in blister (4/2x2/, 8/2x4/),

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK G04BE03 1515117.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3824

Sildenafil Accord

100mg Film coated

Tablets



100mg,


Cemelog-BRS Ltd., H-

2040, Budaors,Vasut

u.13- batch releaser,

Intas Pharmaceuticals

Limited, Plot No 457 &

458 & 191/218 P,


Matoda Village, Sanand,

District-Ahmedabad,

382 210, Gujarat, India-

bulk manufacturer,

Accord Healthcare

Limited, Unit C & D,

Homefield Business




packager

Hungary G04BE03 1515417.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

842

3825

Sildenafil Accord

25mg Film coated

Tablets



25mg,



2040, Budaors,Vasut




458 & 191/218 P,



District-Ahmedabad,


bulk manufacturer,

Accord Healthcare


Homefield Business




packager

Hungary G04BE03 1515317.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3826

Sildenafil Accord

25mg Film coated

Tablets



25mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK G04BE03 1515517.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

843

3827

Sildenafil Accord

50mg Film coated

Tablets



50mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK G04BE03 1515217.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3828

Sildenafil Accord

50mg Film coated

Tablets



50mg,



2040, Budaors,Vasut




458 & 191/218 P,



District-Ahmedabad,


bulk manufacturer,

Accord Healthcare


Homefield Business




packager

Hungary G04BE03 1515617.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3829 Sileo

dexmedetomidine

(dexmedetomidine

hydrochloride)

gel oromucosal0,1mg/ml,

3ml pre-filled syringe (1)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland

QN05CM18;

veterinary

drug

1574704.07.2016

04.07.2021OTC

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

844

3830 Silkaderm tretinoinsolution for topical

use

0,5mg/ml,

30ml glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD10AD01 12536

02.10.2013

02.10.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3831 Silkaderm tretinoin cream0,5mg/g,

15g aluminum tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD10AD01 13552

23.05.2014

23.05.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3832 Silvadev silver sulfadiazine cream10mg/g,

40g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD06BA01 14169

16.01.2015

16.01.2020OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3833 SIMBRINZA

brinzolamide,

brimonidine

(brimonidine

tartrate)

drops eye,

suspension

10mg/ml+2mg/ml, 5ml

plastic vial-dropper

S.A. Alcon-Couvreur

N.V., Rijksweg 14, B-

2870 Puurs

Belgium S01EC54 1630830.12.2016

30.12.2021PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14, B-

2870 Puurs, Belgium

3834 Simdax levosimendanconcentrate for


2,5mg/ml,

5ml glass vial (1)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland C01CX08 1529504.02.2016

04.02.2021PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

3835 Simulect basiliximab

powder lyophilized

for solution for

injection or infusion

20mg,

glass vial and solvent in

ampoule 5ml

Novartis Pharma

Stein AG,


4332 Stein

Switzerland L04AC02 1549512.04.2016

12.04.2021PoM

Novartis Pharma AG,


Basel, Switzerland

845

3836 Simva-Denk 20 simvastatin tablets film-coated20mg,


Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany C10AA01 1622405.12.2016

05.12.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

3837 Simva-Denk 40 simvastatin tablets film-coated40mg,


Denk Pharma GmbH


84529 Tittmoning

Germany C10AA01 1622505.12.2016

05.12.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

3838Simvastatin 20mg

film-coated tabletssimvastatin tablets film-coated

20mg,


Lek S.A.,16 Podlipie

Str., 95-010 Strykow-

batch releaser,

packager, Sandoz

Grup Saglik

Ueruenleri Ilaclari

San. ve A.S., Gebze

Organized Industrial

Region Ihsan Dede,

Cadde No. 900 Sokak,

TR-41480, Gebze-


manufacturer

Poland C10AA01 1646506.03.2017

06.03.2022PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

846

3839Simvastatin 40mg

film-coated tabletssimvastatin tablets film-coated

40mg,


Lek S.A.,16 Podlipie

Str., 95-010 Strykow-

batch releaser,

packager, Sandoz

Grup Saglik

Ueruenleri Ilaclari

San. ve A.S., Gebze

Organized Industrial

Region Ihsan Dede,

Cadde No. 900 Sokak,

TR-41480, Gebze-


manufacturer

Poland C10AA01 1646606.03.2017

06.03.2022PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

3840 Sinaflanfluocinolone

acetonide

ointment for

external use

0,25mg/g,

15g aluminum tube

Open joint stock


zavod medicinskikh

preparatov" 64/27,



Belarus D07AC04 13539/124.07.2014

30.05.2019PoM

Open joint stock


zavod medicinskikh

preparatov" 64/27,


222120, Minsk

region, Belarus


acetonide

ointment for

external use

0,25mg/g,

10g aluminium tube

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia D07AC04 1613410.11.2016

10.11.2021PoM

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia


acetonideointment

0,25mg/g,

15g aluminium tube

"Biohimik " PJSC,


430030, Saransk,

Vasenko str., 15A

Russia D07AC04 1685110.07.2017

10.07.2022PoM

"PROMOMED RUS "

LLC, 101000,

Moscow, Arkhangelsk


Russia

847

3843 Sindranolropinirol (ropinirol

hydrochloride)

tablets prolonged-

release coated

2mg,


56/4x14/), 84/6x14/)


PLC, 1106 Budapest,

Kereszturi st. 30-38 -


manufacturer,

packager -

Pharmathen

International S.A.,


Rodopi Prefecture,

Block No5, Rodopi

69300, Greece)

Hungary N04BC04 12287/120.08.2015

22.03.2018PoM


PLC, 1106 Budapest,


Hungary


hydrochloride)

tablets prolonged-

release coated

3mg,


56/4x14/, 84/6x14/)


PLC, 1106 Budapest,



manufacturer,

packager -

Pharmathen

International S.A.,


Rodopi Prefecture,

Block No5, Rodopi

69300, Greece)

Hungary N04BC04 12288/120.08.2015

22.03.2018PoM


PLC, 1106 Budapest,


Hungary


hydrochloride)

tablets prolonged-

release coated

4mg,


56/4x14/, 84/6x14/)


PLC, 1106 Budapest,



manufacturer,

packager -

Pharmathen

International S.A.,


Rodopi Prefecture,

Block No5, Rodopi

69300, Greece)

Hungary N04BC04 12289/120.08.2015

22.03.2018PoM


PLC, 1106 Budapest,


Hungary

848


hydrochloride)

tablets prolonged-

release coated

8mg,


56/4x14/, 84/6x14/)


PLC, 1106 Budapest,



manufacturer,

packager -

Pharmathen

International S.A.,


Rodopi Prefecture,

Block No5, Rodopi

69300, Greece)

Hungary N04BC04 12290/120.08.2015

22.03.2018PoM


PLC, 1106 Budapest,


Hungary

3847 Sinecodbutamirate

(butamirate citrate)syrup

1,5mg/ml,


measuring cup

Novartis Consumer



269, 1260 Nyon

Switzerland R05DB13 1365708.07.2014

08.07.2019OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

3848Sinecod for

children

butamirate

(butamirate citrate)drops oral

5mg/ml,

20ml glass vial

Novartis Consumer



269, 1260 Nyon

Switzerland R05DB13 1365608.07.2014

08.07.2019OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

3849 Singlon

montelukast

(montelukast

sodium)



Gedeon Richter

Polska Sp.z o.o.,

ul.Graniczna 35,


05-825

Poland R03DC03 1605717.10.2016

17.10.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3850 Singlon

montelukast

(montelukast

sodium)

tablets chewable5mg,


Gedeon Richter

Polska Sp.z o.o.,

ul.Graniczna 35,


05-825

Poland R03DC03 1605817.10.2016

17.10.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

849

3851 Singlon

montelukast

(montelukast

sodium)

tablets chewable4mg,


Gedeon Richter

Polska Sp.z o.o.,

ul.Graniczna 35,


05-825

Poland R03DC03 1605917.10.2016

17.10.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3852 Singulair

montelukast

(montelukast

sodium)

tablets film-coated

10mg,


28/2x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Merck Sharp &

Dohme Ltd., Shotton

Lane, Cramlington,

Northumberland

NE23 3JU, United

Kingdom -bulk

manufacturer

the Netherlands R03DC03 1539809.03.2016

09.03.2021PoM

Schering-Plough

Central East Ag,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

3853 Singulair

montelukast

(montelukast

sodium)

tablets chewable

5mg,


28/2x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Merck Sharp &

Dohme Ltd., Shotton

Lane, Cramlington,

Northumberland

NE23 3JU, United

Kingdom -bulk

manufacturer


09.03.2021PoM

Schering-Plough

Central East Ag,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

850

3854 Singulair

montelukast

(montelukast

sodium)

tablets chewable

4mg,


28/2x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Merck Sharp &

Dohme Ltd., Shotton

Lane, Cramlington,

Northumberland

NE23 3JU, United

Kingdom -bulk

manufacturer


09.03.2021PoM

Schering-Plough

Central East Ag,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

3855 Sinthomycin chloramphenicol liniment100mg/g,

25g aluminium tube

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia D06AX02 1533826.02.2016

26.02.2021OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

3856 Sinupret

gentian radix,

primulae flos,

rumicis herba,

sambuci flos,

verbenae herba

drops oral

2mg/g+6mg/g+

6mg/g+6mg/g+ 6mg/g,

100ml glass container-

dropper

Bionorica SE,

Kerschensteinerstr. 11-

15, 92318 Neumarkt

GermanyR07AX;

herbal drug14568

09.06.2015

09.06.2020PoM

Bionorica SE,

Kerschensteinerstr.

11-15, 92318

Neumarkt, Germany

3857 Sinupret

gentiane radix,

primulae flos,

rumicis herba,

sambuci flos,

verbenae herba

tablets coated

6mg+18mg+18mg+18mg+

18mg, in blister

(50/2x25/)

Bionorica SE,


15, 92318 Neumarkt

GermanyR07AX;

herbal drug14569

09.06.2015

09.06.2020PoM

Bionorica SE,

Kerschensteinerstr.

11-15, 92318

Neumarkt, Germany

3858 Sinupret forte

verbenae herba,

gentian radix,

rumicis herba,

primulae flos,

sambuci flos

tablets coated

36mg+12mg+

36mg+36mg+36mg, in

blister

(20/1x20/, 50/2x25/)

Bionorica SE,


15, 92318 Neumarkt

GermanyR05X;

herbal drug15275

04.02.2016

04.02.2021PoM

Bionorica SE,

Kerschensteinerstr.

11-15, 92318

Neumarkt, Germany

851

3859 Siofor 1000

metformin

(metformin

hydrochloride)

tablets coated1000mg,


Berlin-Chemie AG,

Glienicker Weg 125,D-

12489 Berlin -

packager, batch


manufacturer - Berlin-

Chemie AG,

Tempelhofer Weg 83,

D-12347 Berlin,

Germany)

Germany A10BA02 1268011.07.2013

11.07.2018PoM

Laboratori Guidotti

S.p.A, Via Livornese,

897, 56122 La Vettola

(Pisa), Italy

3860 Siofor 1000

metformin

(metformin

hydrochloride)



Menarini-Von

Heyden GmbH,


01097 Dresden

Germany A10BA02 1519030.12.2015

30.12.2020PoM

Laboratori Guidotti

S.p.A., Via Livornese,

897 56122 La Vettola

(Pisa), Italy

3861 Siofor 1000

metformin

(metformin

hydrochloride)



Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser,

Dragenopharm

Apotheker Puschl


84529 Tittmoning,

Germany-bulk

manufacturer,

packager

Germany A10BA02 1557712.05.2016

12.05.2021PoM

Laboratori Guidotti

S.p.A., Via Livornese,

897 56122 La Vettola

(Pisa), Italy

3862 Siofor 500

metformin

(metformin

hydrochloride)



Berlin-Chemie

A.G.Glienicker Weg

125 D-12489 Berlin-

batch releaser,

packager, Berlin-

Chemie A.G.,

Germany

Tempelhofer Weg 83

D-12347 Berlin-bulk

manufacturer

Germany A10BA02 1334517.03.2014

17.03.2019PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

852

3863 Siofor 500

metformin

(metformin

hydrochloride)



Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser (Menarini-

Von Heyden GmbH,


01097 Dresden,

Germany - bulk

manufacturer,

packager)

Germany A10BA02 1364608.07.2014

08.07.2019PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

3864 Siofor 850

metformin

(metformin

hydrochloride)



Berlin-Chemie

A.G.Glienicker Weg

125 D-12489 Berlin-

batch releaser,

packager, Berlin-

Chemie A.G.,

Germany

Tempelhofer Weg 83

D-12347 Berlin-bulk

manufacturer

Germany A10BA02 1334617.03.2014

17.03.2019PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

3865 Siofor 850

metformin

(metformin

hydrochloride)



Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser (Menarini-

Von Heyden GmbH,


01097 Dresden,

Germany - bulk

manufacturer,

packager)

Germany A10BA02 1364708.07.2014

08.07.2019PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

853

3866 Siofor 850

metformin

(metformin

hydrochloride)



Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin -

packager, batch

releaser (Menarini-

Von Heyden GmbH,


01097 Dresden,

Germany - bulk

manufacturer)

Germany A10BA02 1364808.07.2014

08.07.2019PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

3867 Sirdalud

tizanidine

(tizanidine

hydrochloride)

tablets2mg,


Novartis Saglik, Gida

ve Tarim Urunleri

San.Ve Tic. A.S.,

Yenisehir Mahallesi,

Dedepasa Cadessi N

17 (11. Sok N 2)

34912, Kurtkoy,

Istanbul

Turkey M03BX02 1658203.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

3868 Sirdalud

tizanidine

(tizanidine

hydrochloride)

tablets4mg,



ve Tarim Urunleri

San.Ve Tic. A.S.,


Dedepasa Cadessi N

17 (11. Sok N 2)

34912, Kurtkoy,

Istanbul

Turkey M03BX02 1658303.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

854

3869 Sirturo

bedaquiline

(bedaquiline

fumarate)

tablets100mg,


Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28-

secondary packager,

batch releaser

(Kemwell Biopharma

Pvt. Ltd., 34th km,

Tumkur Road,

Teppada Begur,

Nelamangela Taluk,

Bangalore 562123,

India-bulk

manufacturer,

primary packager)

Russia J04AK 1450415.05.2015

15.05.2020PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

3870 Sivulan

cefepime (cefepime

dihydrochloride

monohydrate)

powder for solution

for i/m and i/v

injection

1000mg,

glass vial (1)

AbiPharm LLC,

Mtskheta district,

village Tsilkani, 3319

Georgia J01DE01 1687908.08.2017

08.08.2022PoM

AbiPharm LLC,

Mtskheta district,

village Tsilkani, 3319,

Georgia

3871 Skinoren azelaic acid gel for external use

150mg/g,

5g and 30g aluminium

tube

Bayer Healthcare

Manufacturing S.r.l.,

Via E. Schering 21,

20090 Segrate

(Milano)

Italy D10AX03 1529904.02.2016

04.02.2021OTC

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

3872 Skinoren azelaic acidcream for external

use

200mg/g,

30g aluminium tube

Bayer Healthcare


Via E. Schering 21,

20090 Segrate

(Milano)

Italy D10AX03 1530004.02.2016

04.02.2021OTC

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

855

3873 Skopryllisinopril (lisinopril

dihydrate)tablets

10mg,


90/9x10/)


Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia)

Slovenia C09BA03 1241525.04.2013

25.04.2018PoM


Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

3874 Skopryllisinopril (lisinopril

dihydrate)tablets

20mg,


90/9x10/)


Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia)

Slovenia C09BA03 1241625.04.2013

25.04.2018PoM


Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

3875 Skopryl Plus

lisinopril (lisinopril

dihydrate),

hydrochlorothia-

zide

tablets

20mg+12,5mg,


30/3x10/)


Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia)

Slovenia C09BA03 1241725.04.2013

25.04.2018PoM


Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

856

3876 Smecta diosmectite

powder for oral

suspension with

orange flavour

3g,

3.76g sachets

(10, 30)

Beaufour Ipsen

Industrie , Ethe

Virton, 28100 Dreux

France A07BC05 1426420.02.2015

20.02.2020OTC

Ipsen Pharma, 65

quai Georges Gorse,

92100 Boulogne-

Billancourt, France

3877SmofKabiven

Central

camera I- L-alanine, L-

arginine, glycine, L-

histidine, L-isoleucine, L-

leucine, L-lysine (lysine

acetate), L-methionine, L-

phenylalanine, L-proline, L-

serine, taurine, L-

threonine, L-triyptophan, L-

tyrosine, L-valine, calcium

chloride(calcium chloride

dihydrate), sodium

glycerophosphate (sodium

glycerophosphate hydrate),

magnesium sulphate

(magnesium sulphate

heptahydrate), potassium

chloride, sodium acetate

(sodium acetate

trihydrate), zinc sulphate

(zinc sulphate

heptahydrate), camera II-

glucose (glucose

monohydrate), camera III-

soya-bean oil, triglycerides,

olive oil, fish oil (rich in

omega-3 acids)

emulsion for

infusion

14mg/ml+12mg/ml+

11mg/ml+3mg/ml+

5mg/ml+7.4mg/ml+

6.6mg/ml+4.3mg/ml+

5.1mg/ml+11.2mg/ml+

6.5mg/ml+1mg/ml+

4.4mg/ml+2mg/ml+

0.4mg/ml+6.2mg/ml+

0.56mg/ml+4.2mg/ml+

1.2mg/ml+4.5mg/ml+

3.4mg/ml+0.013mg/ml+

419.5mg/ml+60mg/ml+

60mg/ml+50mg/ml+ 30mg/ml;

(4) camera set 986ml (plastic

camera I 500ml+plastic camera

II 298ml+plastic camera III

188ml), (4) camera set 1477ml

(plastic camera I 750ml+plastic

camera II 446ml+plastic camera

III 281ml), (4) camera set

1970ml (plastic camera I

1000ml+plastic camera II

595ml+plastic camera III 375ml)

Fresenius Kabi AB,

Rapsgatan 7 Uppsala,

75174

Sweden B05BA10 1466003.07.2015

03.07.2020PoM

Fresenius Kabi

Deutschland GmbH,

61346 Bad Homburg,

v.d.H, Germany

857

3878SmofKabiven

Peripheral

camera I- L-alanine, L-

arginine, glycine, L-

histidine, L-isoleucine, L-

leucine, L-lysine (lysine

acetate), L-methionine, L-

phenylalanine, L-proline, L-

serine, taurine, L-

threonine, L-triyptophan, L-

tyrosine, L-valine, calcium

chloride(calcium chloride

dihydrate), sodium

glycerophosphate (sodium

glycerophosphate hydrate),

magnesium sulphate

(magnesium sulphate

heptahydrate), potassium

chloride, sodium acetate

(sodium acetate

trihydrate), zinc sulphate

(zinc sulphate

heptahydrate), camera II-

glucose (glucose

monohydrate), camera III-

soya-bean oil, triglycerides,

olive oil, fish oil (rich in

omega-3 acids)

emulsion for

infusion

14mg/ml+ 12mg/ml+

11mg/ml+3mg/ml+

5mg/ml+7.4mg/ml+6.6mg/m

l+ 4.3mg/ml+ 5.1mg/ml+

11.2mg/ml+ 6.5mg/ml+

1mg/ml+4.4mg/ml+2mg/ml

+0.4mg/ml+6.2mg/ml+

0.56mg/ml+ 4.18mg/ml+

1.2mg/ml+ 4.5mg/ml+

3.4mg/ml+ 0.013mg/ml+

419.5mg/ml+ 60mg/ml+

60mg/ml+

50mg/ml+30mg/ml, (4)

camera set 1904ml (plastic

camera I /600ml/+plastic

camera II /1036ml/+plastic

camera III /268ml/)

Fresenius Kabi AB,

Rapsgatan 7 Uppsala,

75174

Sweden B05BA10 1465903.07.2015

03.07.2020PoM

Fresenius Kabi

Deutschland GmbH,

61346 Bad Homburg,

v.d.H, Germany

3879 SMOFlipid

soya bean oil,

triglycerides, olive

oil, fish oil (rich in

omega-3 acids)

emulsion for

infusion

60mg/ml+ 60mg/ml+

50mg/ml+30mg/ml,

100ml, 500ml glass bottles

(10)

Fresenius Kabi

Austria GmbH,

Hafnerstrasse 36, 8055

Graz

Germany B05BA02 1462703.07.2015

03.07.2020PoM

Fresenius Kabi

Deutschland GmbH,

61346 Bad Homburg,

v.d.H, Germany

3880 Snup

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

0,5mg/ml,

15ml (150 dose) plastic

bottle

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel -


form manufacturer,

packager - Ursapharm

Arzneimittel GmbH,

Industriestrasse 66129

Saarbrucken,

Germany)

Germany R01AA07 1266204.07.2013

04.07.2018OTC

STADA Arzneimittel


D-61118 Bad Vilbel,

Germany

858

3881 Snup

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

1mg/ml,


bottle

STADA Arzneimittel


D-61118 Bad Vilbel -


form manufacturer,

packager - Ursapharm

Arzneimittel GmbH,

Industriestrasse 66129

Saarbrucken,

Germany)

Germany R01AA07 1266304.07.2013

04.07.2018OTC

STADA Arzneimittel


D-61118 Bad Vilbel,

Germany

3882 Snup

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

1mg/ml,


bottle

STADA Arzneimittel


D-61118 Bad Vilbel-

batch releaser, Famar

Health Care Services

Madrid, S.A.U.,

Avenida de Leganes,

62, Alcorcon, 28923

Madrid, Spain-bulk

manufacturer,

packager

Germany R01AA07 1462303.07.2015

03.07.2020OTC

STADA Arzneimittel


D-61118 Bad Vilbel,

Germany

3883 Snup

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

0,5mg/ml,


bottle

STADA Arzneimittel


D-61118 Bad Vilbel-

batch releaser, Famar

Health Care Services

Madrid, S.A.U.,

Avenida de Leganes,

62, Alcorcon, 28923

Madrid, Spain-bulk

manufacturer,

packager

Germany R01AA07 1462403.07.2015

03.07.2020OTC

STADA Arzneimittel


D-61118 Bad Vilbel,

Germany

859

3884

Sodium

adenosintriphos-

phate-Darnitsa

adenosintriphos-

phate

(adenosintripho-

sphate disodium)



Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Boryspilska Str.,13

Ukraine C01EB10 1588423.08.2016

23.08.2021PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Boryspilska Str.,13,

Ukraine

3885Sodium

bicarbonatesodium bicarbonate solution for infusion

84mg/ml; (1) and (10)

glass vials 20ml

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaB05CB04 12293/1

28.11.2014

22.03.2018PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

3886 Sodium chloride sodium chloridesolution for topical

application

50mg/ml,


(1, 10)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01XA03 16526

17.03.2017

17.03.2022OTC

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

3887 Sodium chloride sodium chloride solution for injection

9mg/ml,

10ml ampoules (10),


(10/2x5/)

Halychpharm JSC,

79024, city of Lviv, st.

Oprishkovskaya, 6/8

Ukraine B05CB01 1670523.05.2017

23.05.2022PoM

Halychpharm JSC,


Oprishkovskaya, 6/8,

Ukraine


9mg/ml,


ampoules,


Halychpharm JSC,


Oprishkovskaya, 6/8

Ukraine B05CB01 1670623.05.2017

23.05.2022PoM

Halychpharm JSC,



Ukraine


9mg/ml,

5ml ampoules (10/1x10/),


(10/2x5/)

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


Belarus B05CB01 1679722.06.2017

22.06.2022PoM

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

860

3890 Sodium chloride sodium chloride solution for infusion

9mg/ml,

50ml, 100ml, 200ml,

250ml, 500ml, 1000ml,

3000ml and 5000ml

plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaB05CB01 17047

25.09.2017

25.09.2022PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

3891 Sodium chloride sodium chloride solution for injection 9mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

Armenia B05CB01 16929

16.08.2017

16.08.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

3892Sodium chloride

solution 0.9%sodium chloride solution for infusion

9mg/ml,

50ml, 100ml, 200ml,

250ml, 400ml, 500ml,

1000ml, 2000ml, 3000ml

plastic pack

PharmaTech CJSC,


str. 111

Republic of

ArmeniaB05CB01 15084

15.12.2015

15.12.2020PoM

PharmaTech CJSC,



Armenia

3893 Sodium oxybate sodium oxybate solution for injection200mg/ml,

10ml ampoules (10)

PJSC "Farmak",

04080, Kiev, Frunze

str. 74

Ukraine N01AX11 1280323.08.2013

23.08.2018PoM/UC

PJSC "Farmak",

04080, Kiev, Frunze

str. 74 for PJSC

"Farmak", 04080,

Kiev, Frunze str. 63,

Ukraine

3894 Sodium thiosulfate sodium thiosulfate solution for injection300mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaV03AB06 16683

31.05.2017

31.05.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

861

3895 Solcoderm

nitric acid 70%,

glacial acetic acid,

oxalic acid

dihydrate, lactic

acid 90%, copper

nitrate trihydrate

solution for external

use

580,66mg/ml+

41,08mg/ml+

57,32mg/ml+ 4,55mg/ml+

0,048mg/ml,

0,2ml ampoule (1)

Legacy

Pharmaceuticals

Switzerland GmbH,

Ruhrbergstrasse 21,

4127 Birsfelden

Switzerland D11AF 1436925.03.2015

25.03.2020PoM

MEDA

Pharmaceuticals

Switzerland GmbH,

Hegnaustrasse 60,

8602 Wangen-

Bruttisellen,

Switzerland

3896 Solcoseryl

hemodialysate from

calves blood protein-

free

gel4,15mg/g,

20g aluminium tube

Legacy

Pharmaceuticals

Switzerland GmbH,

Ruhrbergstrasse 21,

4127 Birsfelden

Switzerland D11AX 1430131.03.2015

31.03.2020OTC

MEDA

Pharmaceuticals

Switzerland GmbH,

Hegnaustrasse 60,

8602 Wangen-

Bruttisellen,

Switzerland

3897 Solcoseryl

hemodialysate from


free


i/m injection

42,5mg/ml,

5ml ampoules (5)

Legacy

Pharmaceuticals

Switzerland GmbH,

Ruhrbergstrasse 21,

4127 Birsfelden

Switzerland B05ZA 1437425.03.2015

25.03.2020PoM

MEDA

Pharmaceuticals

Switzerland GmbH,

Hegnaustrasse 60,

8602 Wangen-

Bruttisellen,

Switzerland

3898 Solcoseryl

hemodialysate from


free


i/m injection

42,5mg/ml,


Legacy

Pharmaceuticals

Switzerland GmbH,

Ruhrbergstrasse 21,

4127 Birsfelden

Switzerland B05ZA 1437525.03.2015

25.03.2020PoM

MEDA

Pharmaceuticals

Switzerland GmbH,

Hegnaustrasse 60,

8602 Wangen-

Bruttisellen,

Switzerland

3899 Solcoseryl

hemodialysate from


free

ointment2,07mg/g,

20g aluminium tube

Legacy

Pharmaceuticals

Switzerland GmbH,

Ruhrbergstrasse 21,

4127 Birsfelden

Switzerland D11AX 1437631.03.2015

31.03.2020OTC

MEDA

Pharmaceuticals

Switzerland GmbH,

Hegnaustrasse 60,

8602 Wangen-

Bruttisellen,

Switzerland

862

3900Solcoseryl Dental

Adhesive Paste

hemodialysate from


free, polidocanol

pastefor local use2.125mg/g+ 10mg/g,

5g aluminium tube

Legacy

Pharmaceuticals

Switzerland GmbH,

Ruhrbergstrasse 21,

4127 Birsfelden

Switzerland A01AD11 1432109.03.2015

09.03.2020OTC

MEDA

Pharmaceuticals

Switzerland GmbH,

Hegnaustrasse 60,

8602 Wangen-

Bruttisellen,

Switzerland

3901 Solcoseryl Eye gel

hemodialysate

protein-free from

calves' blood

gel eye8,3mg/g,

5g aluminum tube

MEDA Pharma

GmbH & Co. KG,

Benzstrasse 1, 61352

Bad Homburg - batch


manufacturer,

packager - Legacy

Pharmaceuticals

Switzerland GmbH,

Ruhrbergstrasse 21,

CH-4127, Birsfelden,

Switzerland)

Germany S01XA 1260621.06.2013

21.06.2018PoM

MEDA Pharma

GmbH, Guglglasse 15,

AT-1110 Wien,

Vienna, Austria

3902 Solcovagin

nitric acid 70%,

glacial acetic acid,

oxalic acid

dihydrate, zinc

nitrate hexahydrate

solution for topical

use

537mg/ml+ 20,4mg/ml+

58,6mg/ml+ 6mg/ml,


Legacy

Pharmaceuticals

Switzerland GmbH,

Ruhrbergstrasse 21,

4127 Birsfelden

Switzerland G02CX 1432209.03.2015

09.03.2020PoM

MEDA

Pharmaceuticals

Switzerland GmbH,

Hegnaustrasse 60,

8602 Wangen-

Bruttisellen,

Switzerland

3903 Solian amisulpridetablets scored film-

coated

400mg,


Sanofi Winthrop

Industrie, 6,

Boulevard de l Europe

21800 Quetigny

France N05AL05 1617623.11.2016

23.11.2021PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain


France

863

3904 Solian amisulpride tablets scored100mg,


Sanofi Winthrop

Industrie, 6,


21800 Quetigny

France N05AL05 1617723.11.2016

23.11.2021PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain


France

3905 Solian amisulpride tablets scored200mg,


Sanofi Winthrop

Industrie, 6,


21800 Quetigny

France N05AL05 1617823.11.2016

23.11.2021PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain


France

3906 Solidagoren

goldenrod liquid

extract, goose grass

herb liquid extract,

horsetail liquid

extract

drops oral

0,79ml/ml,


bottle

Dr. Gustav Klein

GmbH & Co. KG


Zell am Harmersbach)

Germany G04BP50 1297728.10.2013

28.10.2018OTC

Dr. Gustav Klein

GmbH & Co. KG


Zell am Harmersbach,

Germany)

3907 Solpadein

paracetamol,

caffeine, codeine

(codeine phosphate)

tablets soluble500mg+30mg+ 8mg,

strips (12/6x2/)

GlaxoSmithKline

Dungarvan Limited,

Knockbrack,

Dungarvan, Co

Waterford

Ireland N02BE51 14698/130.05.2017

16.07.2020PoM

GlaxoSmithKline

Consumer Healhtcare

(UK) Trading

Limited, 980 Great

West Road,


TW8 9GS, UK

864

3908 Solpadeine

paracetamol,

caffeine, codeine

(codeine phosphate)


in blister (8/1x8/)

GlaxoSmithKline

Dungarvan Limited,

Knockbrack,

Dungarvan, County

Waterford

Ireland N02BE51 15957/104.05.2017

15.09.2021PoM

GlaxoSmithKline

Consumer Healhtcare

(UK) Trading

Limited, 980 Great

West Road,


TW8 9GS, UK

3909 Solpadeine Activeparacetamol,

caffeinetablets soluble

(500mg+65mg), strips

(12/2x6/)

Famar S.A.,

Anthoussa avenue,

Pallini Attikis, Athens

153 44

Greece N02BE51 14145/104.05.2017

29.12.2019OTC

GlaxoSmithKline

Consumer Healhtcare

(UK) Trading

Limited, 980 Great

West Road,


TW8 9GS, UK

3910 Soluferriron (III)-hydroxide

sucrose complex

solution for i/v

injection

20mg/ml,

5ml ampoules (5)

Help S.A. Pedini,


45500

Greece B03AC02 1421003.02.2015

03.02.2020PoM

Moosmann


Vanahovit 8,


Ave., Kotayk Marz

2413, Republic of

Armenia

3911 Solu-Medrol

methylprednisolone

(methylpredniso-

lone sodium

succinate)

powder lyophilized


and i/v injection

500mg,

glass vial with powder (1)

and 7,8ml glass vial with

solvent (1)

Pfizer Manufacturing

Belgium N.V.,

Rijksweg 12, B-2870

Puurs

Belgium H02AB04 1606917.10.2016

17.10.2021PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

3912 Solu-Medrol

methylprednisolone

(methylpredni-

solone sodium

succinate)

powder lyophilized


and i/v injection

1000mg,

glass vial with powder (1)

and 15,6ml glass vial with

solvent (1)


Belgium N.V.,

Rijksweg 12, B-2870

Puurs

Belgium H02AB04 1607017.10.2016

17.10.2021PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

865

3913 Solu-Medrol

methylprednisolone

(methylpredniso-

lone sodium

succinate)

powder lyophilized


and i/v injection

250mg

Act-O-Vial (250mg

powder and 4ml solvent)

(1)


Belgium N.V.,

Rijksweg 12, B-2870

Puurs

Belgium H02AB04 1607117.10.2016

17.10.2021PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

3914Solution Acid

Aminocaproic 5%aminocaproic acid solution for infusion

50mg/ml,

50ml, 100ml, 200ml,

250ml plastic pack

PharmaTech CJSC,


str. 111

Republic of


20.07.2016

20.07.2021PoM

PharmaTech CJSC,



Armenia

3915

Solution glucose

with potassium

chloride

dextrose, potassium

chloridesolution for infusion

45,04mg/ml+ 3,96mg/ml,

50ml, 100ml, 200ml,

222ml, 250ml, 400ml,

500ml plastic pack

PharmaTech CJSC,


str. 111

Republic of

ArmeniaB05BB02 12177/1

28.03.2013

01.02.2018PoM

PharmaTech CJSC,



Armenia

3916

Solution Glucose

with Potassium

chloride

glucose (glucose

monohydrate),

potassium chloride


49.5mg/ml+ 3,96mg/ml,

50ml,100ml, 200ml,

222ml, 250ml, 400ml and

500ml plastic pack

PharmaTech CJSC,


str. 111

Republic of


13.12.2017

13.12.2022PoM

PharmaTech CJSC,



Armenia

3917Solution of caffeine

benzoate 20%

caffeine, sodium

benzoatesolution for injection

87,4mg/ml+ 112,6mg/ml,

10ml ampoules (10)

'Brovafarma' Ltd,18-a,

Nezalezhnosti blvd.,

Brovary, Kyiv region,

07400

Ukraine

QN06BC01

veterinary

drug

1394629.10.2014

29.10.2019PoM

'Brovafarma' Ltd,18-a,

Nezalezhnosti blvd.,

Brovary, Kyiv region,

07400

3918Solution Potassium

Chloride 4%potassium chloride solution for infusion

40mg/ml,


PharmaTech CJSC,


str. 111

Republic of

ArmeniaA12BA01 12632

21.06.2013

21.06.2018PoM

PharmaTech CJSC,


str. 111, Armenia

3919Solution sodium

chloride 10%sodium chloride solution for infusion

100mg/ml,

50ml plastic pack

PharmaTech CJSC,


str. 111

Republic of

ArmeniaB05XA03 12176/1

28.03.2013

01.02.2018PoM

PharmaTech CJSC,



Armenia

866

3920 Soluvit N

thiamine (thiamine

mononitrate),

riboflavin

(riboflavin sodium

phosphate

dihydrate),

nicotinamide,

pyridoxine

(pyridoxine

hydrochloride),

pantothenic acid

(sodium

pantothenate),

ascorbic acid

(sodium ascorbate),

biotin, folic acid,

cyanocobalamine

powder lyophilized

for solution for

infusion

2.5mg+3.6mg+

40mg+4mg+

15mg+100mg+

60mcg+0.4mg+ 5mg,

glass vials, in blister

(10/1x10/)

Fresenius Kabi AB,

Rapsgatan 7, Uppsala,

75174-batch releaser,

Sino- Swed

Pharmaceutical Corp.

Ltd., Mu Haiying 16

Beizha Road, Mashan,

214092 Wuxi, China-

bulk manufacturer,

packager

Sweden A11BA 1465803.07.2015

03.07.2020PoM

Fresenius Kabi

Deutschland GmbH,

61346 Bad Homburg,

v.d.H, Germany

3921 Solvasol injectioncefalexin (cefalexin

sodium)

suspension for

injection

180mg,


Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP

UK

QJ01DB01

veterinary

drug

1231222.03.2013

22.03.2018PoM

Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP, UK

3922 Somazinaciticoline (citicoline

sodium)solution for injection

500mg/4ml,


(5/1x5/)

Ferrer International,

SA., Joan Buscalla,1-9

08173 Sant Cugat del

Valles, Barcelona

Spain N06BX06 1231622.03.2013

22.03.2018PoM


SA., Joan Gran Via

Carlos III, 94 08028,

Barcelona, Spain


sodium)solution oral

100mg/ml,


measuring syringe


SA., Joan Buscalla,1-9


Valles, Barcelona

Spain N06BX06 1231722.03.2013

22.03.2018PoM


SA., Joan Gran Via


Barcelona, Spain

867


sodium)solution for injection

250mg/ml,


(5/1x5/)


S.A., Joan Buscalla,1-9


Valles, Barcelona

Spain N06BX06 1463503.07.2015

03.07.2020PoM


S.A., Joan Gran Via


Barcelona, Spain

3925 Somna-Ritz

passiflora incarnata,

valeriana officinalis,

hypericum

perforatum, melissa

officinalis, crataegus

capsules

100mg+60mg+

50mg+20mg+ 20mg,


30/3x10/)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia N05CX 1368808.07.2014

08.07.2019OTC

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


3926 Somnol zopiclone tablets coated

7,5mg,


20/2x10/)

Grindeks JSC,


1057, Riga

Latvia N05CF01 1619408.12.2016

08.12.2021PoM/UC

Grindeks JSC,



3927 Sonnix

doxylamine

(doxylamine

succinate)

tablets coated15mg,


'ASTRAFARM' LLC,

6 Kyivska St,

Vyshneve, Kyivo-

Sviatoshynskyi

district, Kyiv region,

08132

Ukraine R06AA09 1353730.05.2014

30.05.2019PoM

ASTRAFARM' LLC, 6

Kyivska St, Vyshneve,

Kyivo-Sviatoshynskyi

district, Kyiv region,

08132, Ukraine

3928 Soolantra ivermectin cream

10mg/g,

2g, 15g, 30g, 45g and 60g

plastic tube

Laboratoires

Galderma Z.I.

Montdesir, 74540

Alby-sur-Cheran,

France

France D11AX22 1611510.11.2016

10.11.2021PoM

Galderma SA,

Zugerstrasse 8, CH-

6330 Cham,

Switzerland

3929 Sorbifer Durulesferrous sulphate,

ascorbic acidtablets film-coated

320mg+60mg,

in glass bottle (30, 50)


PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary B03AA07 1639810.02.2017

10.02.2022PoM


PLC, 1106 Budapest,


Hungary

868

3930 Spasgan

metamizole

(metamizole

sodium), pitofenone

(pitofenone

hydrochloride),

fenpiverinium

bromide

tablets

500mg+5mg+ 0,1mg,


100/10x10/)

Wockhardt Limited,

H-14/2,MIDC, Waluj,

Aurangabad-431136

Maharashtra

India N02BB52 1537226.02.2016

26.02.2021OTC

Wockhardt Limited,

Wockhardt

Towers,Bandra Kurla

complex,Bandra

(East), Mumbai-

400051, India

3931 Spasmalgon

metamizole

(metamizole

sodium), pitofenone

(pitofenone

hydrochloride),

fenpiverinium

bromide

tablets

500mg+5mg+ 0,1mg,


20/2x10/, 50/5x10/)

Balkanpharma-

Dupnitsa AD,

str."Samokovsko


2600

Bulgaria N02BB52 1726513.12.2017

13.12.2022OTC

Balkanpharma-

Dupnitsa AD,

str."Samokovsko


2600, Bulgaria

3932

Spasmalgon

500mg/2mg/0,02m

g/ml solution for

injection

metamizole

(metamizole

sodium), pitofenone

(pitofenone

hydrochloride),

fenpiverinium

bromide

solution for i/m

injection

500mg/ml+ 2mg/ml+

0.02mg/ml,


(5/1x5/, 10/1x10/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N02BB52 1604117.10.2016

17.10.2021PoM

Sopharma JSC, str.

Iliensko shosse 16,


3933

Spasmalgon

500mg/2mg/0,02m

g/ml solution for

injection

metamizole

(metamizole

sodium), pitofenone

(pitofenone

hydrochloride),

fenpiverinium

bromide

solution for i/m

injection

500mg/ml+2mg/ml+0.0.2

mg/ml,


(10/1x10/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N02BB52 1604217.10.2016

17.10.2021PoM

Sopharma JSC, str.

Iliensko shosse 16,


869

3934 Spasmobloc

metamizole

(metamizole

sodium), pitofenone

(pitofenone

hydrochloride),

fenpiverinium

bromide

tablets500mg+5mg+ 0,1mg,


ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700

BulgariaA03DA02,

N02BB5212719

23.07.2013

23.07.2018OTC

ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700, Bulgaria

3935 Spasmobruhyoscine

butylbromidesolution for injection

10mg/ml,

2ml ampoules (10)

Brupharmexport

SPRL, Rue de la

Grotte, 14, Brussels,

1020

Belgium A03BB01 1311024.12.2013

24.12.2018PoM

Brupharmexport

SPRL, Rue de la

Grotte, 14, Brussels,

1020, Belgium

3936 Spasmobru

hyoscine

butylbromide

(butylscopolamine)

tablets10mg,



14 Rue de la Grotte, B-

1020 Brussels - batch

releaser (Laboratoria

Wolfs NV, Westpoort

50-58, B-2070

Zwijndrecht, Belgium-

bulk manufacturer,

packager)

Belgium A03BB01 1336304.04.2014

04.04.2019PoM


14 Rue de la Grotte, B-

1020 Brussels,

Belgium

3937 Spasmol

drotaverine

(drotaverine

hydrochloride)

tablets40mg,


Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia A03AD02 1412929.12.2014

29.12.2019OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

870

3938 Spasmomen otilonium bromide tablets film-coated

40mg,


30/3x10/)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser

packager, Berlin-

Chemie A.G.,

Tempelhofer Weg 83,

D-12347

Berlin,Germany-bulk

manufacturer

Germany A03AB06 1509615.12.2015

15.12.2020PoM

A. Menarini Industrie

Farmaceutiche

Riunite S.r.l., Via

Sette Santi, 3 50131

Firenze, Italy

3939 Spasmopriv Forte fenoverine capsules

200mg,

in blister

(10, 20/2x10/)

Laboratorios Legrand

S.A., Calle 19 No. 68

B-50, Bogota, D.C.

Colombia A03AX05 1269223.07.2013

23.07.2018PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

3940 Spasmovax phloroglucinolsolution for i/m and

i/v injection

10mg/ml,

4ml ampoules (10)

Doppel Farmaceutici

S.r.l., Via Volturno

48, Quinto De Stampi,

20089 Rozzano (MI)

Italy A03AX 1637330.12.2016

30.12.2021PoM

SCHARPER S.p.A.,

Viale Ortles 12, 20139

Milan, Italy

3941 Spasmovax ORO

phloroglucinol

(phloroglucinol

dihydrate), 1,3,5-

trimethoxybenzene

tablets80mg+80mg,


Doppel Farmaceutici

S.r.l., Via Volturno

48, Quinto De`

Stampi, 20089

Rozzano (MI)

Italy A03AX 1700805.09.2017

05.09.2022PoM

SCHARPER S.p.A.,

Viale Ortles 12, 20139

Milan, Italy

3942 Spazmaton

metamizole

(metamizole

sodium), pitofenone

(pitofenone

hydrochloride),

fenpiverinium

bromide

tablets

500mg+5mg+ 0,1mg,


50/5x10/)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus N02BB52 1497318.11.2015

18.11.2020OTC

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

871

3943 Spazmaton

metamizole

(metamizole

sodium), pitofenone

(pitofenone

hydrochloride),

fenpiverinium

bromide


2500mg/5ml+ 10mg/5ml+

0,1mg/5ml,

5ml ampoules label

banderol (10),


(10/2x5/)

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


Belarus N02BB52 1624119.12.2016

19.12.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

3944 Speman forte N

withania somnifera,

asteracantha

longifolia, lactuca

serriola, mucuna

pruriens, mosaic

gold, argyrea

speciosa, tribulus

terrestris,

leptadenia

reticulate, rauwolfia

serpentina,

parmelia perlata

tablets

39mg+19mg+

10mg+10mg+

10mg+19mg+

19mg+19mg+

18,75mg+10mg,


Himalaya Drug

Company, N11,

Makali Grama

Dasanapura Hobli,

Nelamangala Taluk,

Bangalore 562 123

India G04BX 1303125.11.2013

25.11.2018PoM

Himalaya Drug

Company, N11,

Makali Grama

Dasanapura Hobli,

Nelamangala Taluk,

Bangalore 562 123,

India

3945 Speman N

withania somnifera,

asteracantha

longifolia, lactuca

serriola, mucuna

pruriens, mosaic

gold, argyreia

speciosa, tribulus

terrestris,

leptadenia

reticulata, parmelia

perlata

tablets

65mg+32mg+

16mg+16mg+

16mg+32mg+

32mg+32mg+ 16mg, in


The Himalaya Drug

Company, No: 11,

Makali Grama

Dasanapura Hobli,

Nelamangala Taluk,

Bangalore 562 123

India G04BX 1310209.12.2013

09.12.2018PoM

The Himalaya Drug

Company, No: 11,

Makali Grama

Dasanapura Hobli,

Nelamangala Taluk,

Bangalore 562 123,

India

872

3946Spiriva, with

inhaler tiotropium bromide

capsules with

powder for

inhalation with

inhaler

18mcg,

in listers (30/3x10/) and

inhaler

Boehringer Ingelheim

Pharma GmbH & Co.

KG, Binger Strasse

173, 55216 Ingelheim

am Rhein

Germany R03BB04 1689808.08.2017

08.08.2022PoM

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

3947 Spirolon 25 spironolactone tablets film-coated25mg,


Remedica Ltd.,

Limassol Industrial

Estate, Aharnon


Cyprus C03DA01 1242129.04.2013

29.04.2018PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol

3948 Spironolactone 25 spironolactone tablets film-coated25mg,


Vardhman Exports, A-

188, T.T.C., MIDC

Industrial Area,

Khairane, Navi

Mumbai- 400 710

India C03D A01 1353530.05.2014

30.05.2019PoM

Vardhman Exports,

Ghatkopar (W),

Mumbai-400086 ,

India

3949 Spitomin buspirone tablets10mg,



PLC, 1165 Budapest,



packager, Egis


9900, Kormend,


Hungary- bulk

manufacturer

Hungary N05BE01 1537626.02.2016

26.02.2021PoM


PLC, 1106 Budapest,


Hungary

873

3950 Spitomin buspirone tablets5mg,



PLC, 1165 Budapest,



packager, Egis


9900, Kormend,


Hungary- bulk

manufacturer

Hungary N05BE01 1537726.02.2016

26.02.2021PoM


PLC, 1106 Budapest,


Hungary

3951 Spray Golden star

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

1mg/ml,


pump dispenser

Danapha

Pharmaceutical JSC,

253 Dung Si Thanh

Khe str., Thanh Khe

District, Danang city

Vietnam R01AA07 1685310.07.2017

10.07.2022OTC

Dahnson Trading

Pharmaceutical

Company Limited,

HoChiMinh city, 44A

Dang Dung street,

Tan Dinh ward,

District 1, Vietnam

3952 Stazex

clopidogrel

(clopidogrel

hydrosulfate)



GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia B01AC04 1475503.08.2015

03.08.2020PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


3953 Stimol citrulline malate solution oral100mg/ml,

10ml sachets (18)

Biocodex,1 avenue


Beauvais

France A16AA07 1285517.09.2013

17.09.2018OTC

Biocodex, 7 avenue

Gallieni 94250

Gentilly, France

3954 Stimol citrulline malate

powder effervescent

for oral solution with

strawberry flavour

1000mg,

2.8g sachets (18)

Biocodex,1 avenue


Beauvais

France A13A 1535326.02.2016

26.02.2021OTC

Biocodex, 7 avenue

Gallieni 94250

Gentilly, France

874

3955 Stimulotonsertraline (sertraline

hydrochloride)tablets film-coated

50mg,


(20/2x10/) and (30/3x10/)


PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary N06AB06 1715307.11.2017

07.11.2022PoM


PLC, 1106 Budapest,


Hungary

3956 Stomagel

methyluracil,


hydrochloride),

silbiol

gel for external use5mg/g+20mg/g+ 10mg/g,

15g aluminium tube

"LMP" Ltd., 1,


LV-1009

Latvia A01AD11 1628219.12.2016

19.12.2021OTC

"LMP" Ltd., 1,


LV-1009, Latvia

3957 Stomalox

aluminium

hydroxide,

magnesium

hydroxide

tablets chewable

400mg+400mg,

in blisters (30/5x6/) and

(40/4x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA02AD01 14483/1

25.12.2015

18.05.2020OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

3958 Stopangin hexetidine spray

1,92mg/ml,

30ml plastic bottle and

applicator

TEVA Czech

Industries s.r.o.,


747 70 Opava-

Komarov

Czech Republic A01AB12 1278714.08.2013

14.08.2018OTC

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p.

305, 747 70 Opava-

Komarov, Czech

Republic

3959 Stopdiar nifuroxazide capsules200mg,


Gedeon Richter



5 , Grodzisk


batch releaser

(Gedeon Richter

Poland Sp.z o.o.,

ul.Graniczna

35,Grodzisk

Mazowiecki, 05-825,

Poland - bulk

manufacturer,

packager)

Poland A07AX03 1411129.12.2014

29.12.2019PoM

Gedeon Richter


21, 1103 Budapest,

Hungary

875

3960 Stopdiar nifuroxazide suspension oral

44mg/ml,

90ml glass bottle and dual

measuring spoon

(2.5ml/5ml)

Gedeon Richter



5 , Grodzisk

Mazowiecki, 05-825-

batch releaser, S.C.

Gedeon Richter

Romania S.A., 99-105

Guza Voda str.,

540306, Targu-Mures,

Romania- bulk

manufacturer,

packager

Poland A07AX03 1470416.07.2015

16.07.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3961 Stopdiar nifuroxazide tablets film-coated100mg,


Gedeon Richter



5, Grodzisk

Mazowiecki, 05-825-

batch releaser,

Gedeon Richter


Graniczna 35,


05-825, Poland -bulk

manufacturer,

primary and

secondary packager

Poland A07AX03 1501502.12.2015

02.12.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3962 Stopress

perindopril

(perindopril tert-

butylamine)

tablets4mg,


Pharmaceutical

Works Polpharma

S.A., ul. Pelplinska 19,

83-200 Starogard

Gdanski

Poland C09AA04 1588023.08.2016

23.08.2021PoM

Pharmaceutical

Works Polpharma

S.A., ul. Pelplinska

19, 83-200 Starogard

Gdanski, Poland

876

3963 Stopress

perindopril

(perindopril tert-

butylamine)

tablets8mg,


Pharmaceutical

Works Polpharma


83-200 Starogard

Gdanski

Poland C09AA04 1588123.08.2016

23.08.2021PoM

Pharmaceutical

Works Polpharma



Gdanski, Poland

3964 Stoptussin

butamirate

(butamirate citrate),

guaifenesin

tablets4mg+100mg,


TEVA Czech

Industries s.r.o.,


747 70 Opava-

Komarov

Czech Republic R05FB02 1278614.08.2013

14.08.2018OTC

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel

3965 Stoptussin

guaifenesin,

butamirate

(butamirate citrate)

tablets100mg+4mg,


TEVA Operations

Poland Sp. z o.o,

Mogilska str. 80, 31-

546 Krakow

Poland R05FB02 1305025.11.2013

25.11.2018OTC

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel

3966 Strepsils

dichlorobenzyl

alcohol,

amylmetacresol

lozenges sugar free,

with strawberry

flavour

1,2mg+0,6mg,


Reckitt Benckiser

Healthcare

International Limited,

Nottingham site,

Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

UK R02AA20 14817/121.04.2016

04.09.2020OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB, UK

3967 Strepsils

dichlorobenzyl

alcohol,

amylmetacresol

lozenges sugar free,

with lemon flavour

1,2mg+0,6mg,


24/2x12/)

Reckitt Benckiser

Healthcare


Nottingham site,

Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

UK R02AA20 1503802.12.2015

02.12.2020OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB, UK

877

3968 Strepsils

dichlorobenzyl

alcohol,

amylmetacresol

lozenges1,2mg+0,6mg,


Reckitt Benckiser

Healthcare


Nottingham site,

Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

UK R02AA20 1505902.12.2015

02.12.2020OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB, UK

3969 Strepsils

dichlorobenzyl

alcoholl,

amylmetacresol

lozenges with honey

and lemon flavour

1,2mg+0,6mg,


36/3x12/)

Reckitt Benckiser

Healthcare


Nottingham site,

Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

UK R02AA20 1506002.12.2015

02.12.2020OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB, UK

3970 Strepsils Express

dichlorobenzyl

alcohol,

amylmetacresol,

lidocaine

lozenges with lemon

flavour

1,2mg+0.6mg+ 10mg, in

blister (24/2x12/, 24/3x8)

Reckitt Benckiser

Healthcare


Nottingham site,

Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

UK R02AA20 15040/208.12.2017

02.12.2020OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

3971 Strepsils Intensive flurbiprofenlozenges with honey

and lemon flavour

8,75mg,


Reckitt Benckiser

Healthcare


Nottingham site,

Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

UK R02AX01 1503702.12.2015

02.12.2020OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB, UK

878

3972 Strepsils Plus

dichlorobenzyl

alcohol,

amylmetacresol,

lidocaine

dosed spray for

topical use

0.58mg/push+

0.29mg/push+

0.78mg/push,

20ml (140push (70 dose))

glass bottle with dispenser

Famar Nederland

B.V., Industrieweg 1,

5531 AD Bladel

the Netherlands R02AA20 1479504.09.2015

04.09.2020OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB, UK

3973

Strepsils with

Menthol and

Eucalyptus

dichlorobenzyl

alcohol,

amylmetacresol,

levomenthol

lozenges

1,2mg+0,6mg+ 8mg,


36/3x12/)

Reckitt Benckiser

Healthcare


Nottingham site,

Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

UK R02AA20 1503902.12.2015

02.12.2020OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB, UK

3974Strepsils with

vitamin C

dichlorobenzyl

alcohol,

amylmetacresol,

ascorbic acid

lozenges with orange

flavour

1.2mg+0.6mg+ 100mg,


Reckitt Benckiser

Healthcare


Nottingham site,

Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

UK 15036/108.12.2017

02.12.2020OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB, UK

3975 Streptocid sulfanilamidepowder for external

use

300mg,

sachets (10)


Norq, Mikoyan 13,

Yerevan

Republic of

ArmeniaD06BA05 12818

17.09.2013

17.09.2018OTC


Norq, Mikoyan 13,


Armenia

3976 Streptomycin

streptomycin

(streptomycin

sulfate)

powder for solution

for injection

500mg,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01GA01 1598115.09.2016

15.09.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

879

3977 Streptomycin

streptomycin

(streptomycin

sulfate)

powder for solution

for injection

1000mg,

glass vials (40)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01GA01 1598215.09.2016

15.09.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

3978Streptomycin

sulfate

streptomycin

(streptomycin

sulfate)

powder lyophilized


injection

1000mg,


"Sintez" OJSC, Pr.


Kurgan, 640008

Russia

QJ01GA01;

veterinary

drug

1554619.04.2016

19.04.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640008

3979Streptomycin

sulfate

streptomycin

(streptomycin

sulfate)

powder for solution

for i/m injection

1000mg,


"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01GA01 1620608.12.2016

08.12.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

3980

Streptomycin

Sulphate Reig Jofre

1g

streptomycin

(streptomycin

sulfate)

powder for solution

for injection

1000mg,


LABORATORIO

REIG JOFRE, S.A.,

Gran Capitan, 10,

08970 Sant Joan

Despi, Barcelona-

batch releaser,

B.BRAUN MEDICAL,

S.A., Ronda de Los

Olivares, parcela 11,

Poligono Industrial

Los Olivares, Jaen

23009 (Jaen), Spain-

bulk manufacturer,

packager

Spain J01GA01 1586909.08.2016

09.08.2021PoM

LABORATORIO

REIG JOFRE, S.A.,

Gran Capitan, 10,

08970 Sant Joan

Despi, Barcelona,

Spain

3981 Stresametifoxine (etifoxine

hydrochloride)capsules

50mg,


Biocodex,1 avenue


Beauvais

France N05BX03 1225707.03.2013

07.03.2018PoM

Biocodex, 7 avenue

Gallieni 94250

Gentilly, France

880

3982Stronger Neo-

Minophagen C

monoammonium

glycyrrhizinate

(glycyrrhizic acid),

glycine, L-cysteine

hydrochloride

hydrate (L-cysteine

hydrochloride)


53mg/20ml (40mg/20ml)+

400mg/20ml+

22,29mg/20ml

(20mg/20ml),

20ml ampoules (30)

Minophagen

Pharmaceutical Co.,

Ltd,. 2-3,

Komatsubara 2-

chome, Zama-shi,

Kanagawa

Japan A05B 1441908.04.2015

08.04.2020PoM

Minophagen

Pharmaceutical Co.,

Ltd., Shinjuku Mitsui

Building #2, 3-2-11,

Nishi-Shinjuku,

Shinjuku-ku,

Tokyo,160-0023,

Japan

3983 Strophanthin-G strophanthin-G solution for injection

0,25mg/ml,



(10/2x5/, 10/1x10/)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine C01AC01 1634930.12.2016

30.12.2021PoM

Experimental Plant

"GNCLS" LLC, 61057,

Kharkov, Vorobyova

str., 8, Ukraine

3984 Structum

chondroitin sulfate

(chondroitin sulfate

sodium)

capsules

500mg,


60/5x12/)

Pierre Fabre

Medicament

Production, site

Progipharm, Rue du

Lycee, 45500 Gien

France M01AX25 1563224.05.2016

24.05.2021OTC

Pierre Fabre

Medicament

Production, 45, place

Abel Gance, 92100

Boulogne, France

3985 Stugeron cinnarizine tablets25mg,



Gyomroi ut 19-21,

1103 Budapest

Hungary N07CA02 1441116.04.2015

16.04.2020PoM

Gedeon Richter


21, 1103 Budapest,

Hungary

3986 Suaron nimesulide tablets100mg,


GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia M01AX17 1405119.12.2014

19.12.2019PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


3987 Suaron nimesulidepowder for oral

suspension

100mg,

sachets (10)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia M01AX17 1405219.12.2014

19.12.2019PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


881

3988 SUBRociTRONN

ceftriaxone

(ceftriaxone

sodium), sulbactam

(sulbactam sodium)

powder for solution

for i/v and i/m

injection

500mg+250mg, 10ml glass

vial



Rabele, Thane-

Belapur Road, Navi

Mumbai Pin 400 701

India J01DD54 1316710.01.2014

10.01.2019PoM

S.P. Incomed Pvt.

Ltd., H-680 Palam

Extn.-1, New Delhi

110 045, India

3989 SUBRociTRONN

ceftriaxone

(ceftriaxone

sodium), sulbactam

(sulbactam sodium)

powder for solution

for i/v and i/m

injection

1000mg+500mg, 20ml

glass vial



Rabele, Thane-

Belapur Road, Navi

Mumbai Pin 400 701

India J01DD54 1316810.01.2014

10.01.2019PoM

S.P. Incomed Pvt.

Ltd., H-680 Palam

Extn.-1, New Delhi

110 045, India

3990 Sulbactacid

ampicillin

(ampicillin sodium),

sulbactam

(sulbactam sodium)

powder for solution

for injection

1000mg+500mg, glass

vial (50)


Valea Lupului,

707410 lasi- batch

releaser, packager,

Zhuhai United

Laboratories Co., Ltd,

Sanzao Science &

Technology Park

National Hi-Tech

Zone, Zhuhai,

Guangdong , 519040,

China- bulk

manufacturer

Romania J01CR01 1728413.12.2017

13.12.2022PoM


Valea Lupului,


3991 Sulfacyl-sodium

sulfacetamide

(sulfacetamide

sodium)

drops eye300mg/ml,

5ml vial and dropper

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus S01AB04 1389606.10.2014

06.10.2019OTC

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

3992 Sulfargin silver sulfadiazineointment for

external use

10mg/g,

50g aluminium tube

GRINDEKS JSC,


Riga, LV-1057

Latvia D06BA01 1393829.10.2014

29.10.2019OTC

GRINDEKS JSC,



882

3993 Sulfargin silver sulfadiazineointment for

external use

10mg/g,

50g aluminium tube

Tallinn

Pharmaceutical Plant

JSC, Tondi 33, 11316

Tallinn

Estonia D06BA01 1717930.11.2017

30.11.2022OTC

Grindeks JSC,



3994 Sulfasalazin sulfasalazine tablets film-coated500mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A07EC01 1614423.11.2016

23.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3995 Sulfasalazin sulfasalazine tablets film-coated500mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch

releaser, bulk

manufacturer, KRKA

d.d., Novo mesto,

Ulica Rada Pusenjaka

10, Ljutomer, 9240,

Slovenia-packager

Slovenia A07EC01 1614523.11.2016

23.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3996 Sulfasalazine-EN sulfasalazinetablets gastro-

resistant

500mg; (50/5x10/), in

blister

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A07EC01 1570622.06.2016

22.06.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3997 Sulfocamphocainesulfocamphoric

acid, procaine basesolution for injection

49,6mg/ml+ 50,4mg/ml,

2ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaR01AB 15708

22.06.2016

22.06.2021PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

3998Sulfocamphocaine-

Darnitsa

sulfocamphoric

acid, procaine basesolution for injection

49,6mg/ml+ 50,4mg/ml,

(10/2x5/) ampoules 2ml,

in blister

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine C01EB 1542516.03.2016

16.03.2021PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine

883

3999 Sulphaprimsulfamethoxazole,

trimethoprimsuspension oral


glass bottle and measuring

cup


Ararat province,

Masis city, Masis


22

Republic of

ArmeniaJ01EE01 13685

08.07.2014

08.07.2019PoM


Ararat province,

Masis city, Masis


22, Republic of

Armenia

4000 Sulpiryd sulpiride tablets

200mg,


30/2x15/)

TEVA Operations

Poland Sp. z o.o,


546 Krakow

Poland N05AL01 1371524.07.2014

24.07.2019PoM

TEVA Operations

Poland Sp. z o.o,


546 Krakow, Poland

4001 Sulpiryd sulpiride capsules50mg,


TEVA Operations

Poland Sp. z o.o,


546 Krakow

Poland N05AL01 1379605.09.2014

05.09.2019PoM

TEVA Operations

Poland Sp. z o.o,


546 Krakow, Poland

4002 Sulpiryd sulpiride capsules100mg,


TEVA Operations

Poland Sp. z o.o,


546 Krakow

Poland N05AL01 1379705.09.2014

05.09.2019PoM

TEVA Operations

Poland Sp. z o.o,


546 Krakow, Poland

4003 Sumamed

azithromycin

(azithromycin

dihydrate)

powder lyophilized

for solution for

infusion

500mg,

glass vial (5)


Prilaz baruna

Filipovica 25, 10000

Zagreb - batch


manufacturer - Cadila

Healthcare Ltd.,

Sarkhej-Bavla

National Highway No

8A, Moraiya, Tal.

Sanand, Dist.

Ahmedabad 382 210,

India)

Croatia J01FA10 1255706.06.2013

06.06.2018PoM


Prilaz baruna

Filipovica 25, 10000

Zagreb, Croatia

884

4004 Sumatriptan

sumatriptan

(sumatriptan

succinate)


in blister (2/1x2/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N02CC01 1621908.12.2016

08.12.2021PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

4005 Sumatriptan

sumatriptan

(sumatriptan

succinate)


in blister (2/1x2/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N02CC01 1622008.12.2016

08.12.2021PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

4006 Suplasyn

hyaluronic acid

(sodium

hyaluronate)

solution for injection20mg/2ml,


Mylan Institutional,

Coill Rua, Inverin Co.

Galway, Ireland

Ireland M09AX01 15000/208.12.2017

24.11.2020PoM

Mylan Pharma Group

Limited, Coill Rua,

Inverin Co. Galway,

Ireland

4007 Supradyn

vitamin A, vitamin

B1, vitamin B2,

vitamin B5, vitamin

B6, vitamin B12,

vitamin C, vitamin

D3, vitamin E,

vitamin K1, biotin,

folic acid,

nicotinamide,

calcium,

magnesium, iron,

manganese,

phosphorus,

fluorine, copper,

zinc, iodine,

selenium

tablets effervescent

2666IU+4.2mg+

4.8mg+18mg+6mg+3mcg+

180mg+ 200IU+10mg+

0.03mg+0.45mg+

0.6mg+54mg+

120mg+45mg+

8mg+1.8mg+

126.3mg+1.5mg+

0.9mg+8mg+ 0.075mg+

0.055mg, (15/1x15/),

(30/2x15/) and (45/3x15/)

in aluminium or plastic

tube (15/1x15/, 30/2x15/,

45/3x15/)

Delpharm Gaillard,


74240 Gaillard

France A11AA 1721208.12.2017

08.12.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

885

4008 Supradyn energy

Vitamin A, Vitamin

B1, Vitamin B2,

Vitamin B6,

Vitamin B12,

Vitamin C, Vitamin

D3, Vitamin E,

Vitamin K, biotin,

pantothenic acid,

folic acid,

nicotinamide,

calcium, chromium,

magnesium, iron,

fluorine,

manganese,

phosphorus, copper,

iodine, zinc,

molybdenum,

selenium

tablets film-coated

2666IU+4,2mg+

4,8mg+6mg+

3mcg+180mg+

200IU+10mg+

30mcg+0,45mg+

18mg+0,6mg+

54mg+120mg+

25mcg+45mg+

8mg+1,5mg+

1,8mg+126,3mg+

0,9mg+75mcg+

8mg+45mcg+ 55mcg,

in plastic container (30,

60, 90)

Rottendorf Pharma

GmbH, Ostenfelder

Strasse 51-61, 59320

Ennigerloh

Germany A11AA03 1255806.06.2013

06.06.2018OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

4009 Supradyn energy

vitamin A, vitamin

B1, vitamin B2,

vitamin B6, vitamin

B12, vitamin C,

vitamin D3, vitamin

E, vitamin K,

biotin, pantothenic

acid, folic acid,

nicotinamide,

calcium,

magnesium, iron,

fluorine,

manganese,

phosphorus, copper,

iodine, zinc,

selenium

tablets film-coated

2666IU+4,2mg+

4,8mg+6mg+3mcg+180mg

+200IU+ 10mg+30mcg+

0,45mg+18mg+

0,6mg+54mg+

120mg+45mg+

8mg+1,5mg+1,8mg+126,3

mg+0,9mg+75mcg+8mg+

55mcg,


60, 90)

Rottendorf Pharma

GmbH, Ostenfelder

Strasse 51-61, 59320

Ennigerloh

Germany A11AA03 1663425.04.2017

25.04.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

4010 Suprastin

chloropyramine

(chloropyramine

hydrochloride)

tablets

25mg,

in blister (20/2x10/), in

glass container (20)


PLC, 1165 Budapest,


120

Hungary R06AC03 1502502.12.2015

02.12.2020OTC


PLC, 1106 Budapest,


Hungary

886

4011 Suprastin

chloropyramine

(chloropyramine

hydrochloride)


20mg/ml,


(5/1x5/)


PLC, 1165 Budapest,


120

Hungary R06AC03 1502602.12.2015

02.12.2020PoM


PLC, 1106 Budapest,


Hungary

4012 Supraxcefixime (cefixime

trihydrate)capsules

400mg,

in blister (6/1x6/)

Hikma

Pharmaceuticals,

P.O.Box 182400,

Bayader Wadi Al-

Seer, Amman, 11118-

batch releaser,

packager, Jazeera

Pharmaceutical

Industries, P.O.Box

106229, Heet

Industrial Area, Al

Kharj Road, Exit 11,

Riyadh, 11666, Saudi

Arabia-bulk

manufacturer

Jordan J01DD08 1436425.03.2015

25.03.2020PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

4013 Supraxcefixime (cefixime

trihydrate)

granules for oral

suspension

100mg/5ml,


spoon

Hikma

Pharmaceuticals,

P.O.Box 182400,

Bayader Wadi Al-

Seer, Amman, 11118-

batch releaser,

packager, Jazeera

Pharmaceutical

Industries, P.O.Box

106229, Heet

Industrial Area, Al

Kharj Road, Exit 11,

Riyadh, 11666, Saudi

Arabia-bulk

manufacturer

Jordan J01DD08 1436525.03.2015

25.03.2020PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

887

4014 Suprax Solutabcefixime (cefixime

trihydrate)tablets dispersible

400mg,

in blister (1, 5, 7,

10/1x10/, 10/2x5/)

A.Menarini

Manufacturing

Logistics and Services

S.r.l., Via di Scandicci

37, 50143 Firenze

Italy J01DD08 14999/117.10.2017

24.11.2020PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

4015 Suprostilin

chloropyramine

(chloropyramine

hydrochloride)

tablets

25mg,


20/2x10/)

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov

Ukraine R06AC03 1342614.04.2014

14.04.2019OTC

Lekhim-Kharkiv JSC,


str., 61115 Kharkov,

Ukraine

4016 Survanta beractant

(phospholipids)

suspension

intratracheal

25mg/ml,

4ml glass vial

AbbVie Inc., 1401

Sheridan Road, North

Chicago, Illinois

60064

USA R07AA30 1693123.08.2017

23.08.2022PoM

AbbVie

Biopharmaceuticals

GmbH, Neuhofstrasse

23, 6341 Baar,

Switzerland

4017 Sutentsunitinib (sunitinib

maleate)capsules

12,5mg,


Pfizer Italia S.R.L.,

Localita Marino del

Tronto 63100 Ascoli

Piceno

Italy L01XE04 1264204.07.2013

04.07.2018PoM

Pfizer Ltd., Ramsgate

Road, Sandwich, Kent

CT13 9NJ, UK


maleate)capsules

25mg,



Localita Marino del

Tronto 63100 Ascoli

Piceno

Italy L01XE04 1264304.07.2013

04.07.2018PoM



CT13 9NJ, UK


maleate)capsules

50mg,



Localita Marino del

Tronto 63100 Ascoli

Piceno

Italy L01XE04 1264404.07.2013

04.07.2018PoM



CT13 9NJ, UK

4020 Sutrilneo torasemidetablets prolonged-

release

10mg,





Valles, Barcelona

Spain C03CA04 15001/101.04.2016

24.11.2020PoM


S.A., Gran Via Carlos

III, 94 08028,

Barcelona, Spain

888

4021 Sutrilneo torasemidetablets prolonged-

release

5mg,





Valles, Barcelona

Spain C03CA04 15002/101.04.2016

24.11.2020PoM


S.A., Gran Via Carlos

III, 94 08028,

Barcelona, Spain

4022 Sydnopharm molsidomine tablets2mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria C01DX12 1218101.02.2013

01.02.2018PoM

Sopharma JSC, str.

Iliensko shosse 16,


4023 Sympathyl

eschscholtzia

extract, hawthorn

extract, magnesium

oxide

tablets film-coated20mg+75mg+ 124,35mg,


Innothera Chouzy,

Rue Rene Chantereau

L` lsle Vert 41150,

Chouzy sur Cisse

FranceN05CM;

herbal drug 14733

20.07.2015

20.07.2020PoM


International, 22

Avenue Aristide

Brand 94110 Arcueil,

France

4024 Synflorix

Pneumococcal


Pneumococcal


Pneumococcal


Pneumococcal

polysaccharide serotype 6B,

Pneumococcal

polysaccharide serotype 7F,

Pneumococcal

polysaccharide serotype 9V,

Pneumococcal


Pneumococcal


18C, Pneumococcal


19F, Pneumococcal


23F

suspension for

injection

1mcg/dose+ 3mcg/dose+




3mcg/dose+ 1mcg/dose,

1ml glass vials (2 dose)

(100)

GlaxoSmithKline




releaser

(GlaxoSmithKline

Biologicals SA, Rue

des Aulnois, 637

59230 Saint-Amand-

Les-Eaux, France-

bulk manufacturer,

packager) for

GlaxoSmithKline



1330 Rixensart,

Belgium

BelgiumJ07AL52;

vaccine15823

20.07.2016

20.07.2021PoM

889

4025 Synthomycin chloramphenicol liniment10mg/g,

25g aluminum tube

Altayvitamini CJSC,

659325, The Altay


Zavodskaya Str.

Russia D06AX02 1337704.04.2014

04.04.2019OTC

Altayvitamini CJSC,

659325, The Altay


Zavodskaya Str.,

Russia

4026 Tabex cytisine tablets film-coated1,5mg,


Sopharma JSC,

Vrabevo vlg. 5660,

district of Lovetch

Bulgaria N07BA 1217801.02.2013

01.02.2018OTC

Sopharma JSC, str.

Iliensko shosse 16,


4027Tablets for cough

Tatpharm

thermopsis herb,

sodium

hydrocarbonate

tablets6,7mg+250mg,

in strip (10)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

RussiaR05CA10;

herbal drug17094

23.10.2017

23.10.2022OTC

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

4028 Tachyben urapidilsolution for i/v

injection

5mg/ml,

5ml ampoules (5)

EVER Neuro Pharma

GmbH, Oberburgau

3, 4866 Unterach -


form manufacturer,

packager - Cenexi, 52

rue Marcel et Jacques

Gaucher, Fontenay

Sous Bois, 94120,

France)

Austria C02CA06 1308309.12.2013

09.12.2018PoM

EVER Neuro Pharma

GmbH Oberburgau 3,

4866 Unterach,

Austria


injection

5mg/ml,

10ml ampoules (5)

EVER Neuro Pharma

GmbH, Oberburgau

3, 4866 Unterach -


form manufacturer,



Gaucher, Fontenay

Sous Bois, 94120,

France)

Austria C02CA06 1308409.12.2013

09.12.2018PoM

EVER Neuro Pharma

GmbH Oberburgau 3,

4866 Unterach,

Austria

890


injection

5mg/ml,

20ml ampoules (5)

EVER Neuro Pharma

GmbH, Oberburgau

3, 4866 Unterach -


form manufacturer,



Gaucher, Fontenay

Sous Bois, 94120,

France)

Austria C02CA06 1308509.12.2013

09.12.2018PoM

EVER Neuro Pharma

GmbH Oberburgau 3,

4866 Unterach,

Austria

4031 Tacni tacrolimus capsules

0,5mg,

blisters (50/5x10/), in

aluminium pack

Laboratories Cinfa

S.A., Olaz-Chipi, 10,

Poligono Areta,

Huarte, 31620

Navarra - batch

releaser (Laboratories

Cinfa S.A., Avda. de

Roncesvalles s/n.

Olloki, 31699

Navarra, Spain - bulk

manufacturer)

Spain L04AD02 1345006.05.2014

06.05.2019PoM

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel


1mg,


aluminium pack

Laboratories Cinfa


Poligono Areta,

Huarte, 31620

Navarra - batch



Roncesvalles s/n.

Olloki, 31699


manufacturer)

Spain L04AD02 1345106.05.2014

06.05.2019PoM

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel

891


5mg,


aluminium pack

Laboratories Cinfa


Poligono Areta,

Huarte, 31620

Navarra - batch



Roncesvalles s/n.

Olloki, 31699


manufacturer)

Spain L04AD02 1345206.05.2014

06.05.2019PoM

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel

4034 Taflotan tafluprost drops eye

15mcg/ml,

2,5ml plastic bottle-

dropper

Santen Oy,

Niittyhaankatu 20,

33720 Tampere -

secondary packager,

batch releaser (Santen

Pharmaceutical Co.

Ltd., Shiga Plant 348-

3, Aza-suwa, Oaza-

shide, Taga-cho,

Inukami-gun, Shiga

522-0314, Japan -

bulk manufacturer,

primary packager)

Finland S01EE05 1370224.07.2014

24.07.2019PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

4035 Taflotan tafluprost drops eye

15mcg/ml,

0,3ml single-dose

containers , in aluminium

pack (30/3x10/)

Santen Oy,

Niittyhaankatu 20,

33720 Tampere

Finland S01EE05 1370324.07.2014

24.07.2019PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

4036 Talliton carvedilol tablets

25mg,


28/2x14/)


PLC, 1165 Budapest,


120

Hungary C07AG02 1501602.12.2015

02.12.2020PoM


PLC, 1106 Budapest,


Hungary

892


12,5mg,


28/2x14/)


PLC, 1165 Budapest,


120

Hungary C07AG02 1501702.12.2015

02.12.2020PoM


PLC, 1106 Budapest,


Hungary


6,25mg,


28/4x7/)


PLC, 1165 Budapest,


120

Hungary C07AG02 1501802.12.2015

02.12.2020PoM


PLC, 1106 Budapest,


Hungary

4039 Tamiflu

oseltamivir

(oseltamivir

phosphate)

capsules hard75mg,


F. Hoffmann-La

Roche Ltd.,


Basel, CH-4070-batch

releaser, F. Hoffmann-

La Roche Ltd.,

Wurmisweg CH-4303

Kaiseraugust,

Switzerland-packager,

Cenexi SAS, 52 rue

Marcel et Jacques

Gaucher, Fontenay

Sous Bois, 94120,

France- bulk

manufacturer

Switzerland J05AH02 1435325.03.2015

25.03.2020PoM

F. Hoffmann La

Roche Ltd.,


Basel, CH-4070,

Switzerland

893

4040 Tamiflu

oseltamivir

(oseltamivir

phosphate)

powder for oral

suspension

6mg/ml,

glass bottle (1) plastic

bottle adaptor, plastic

measuring cup 55ml and

oral dispenser

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel-

batch releaser,

Rottendorf Pharma

GmbH, Ostenfelder

Strasse 51-61, 59320

Ennigerloh, Germany-

bulk manufacturer, F.

Hoffmann-La Roche

Ltd, Betriebsstandort

Kaiseraugst, 4303

Kaiseraugst,

Switzerland-packager

Switzerland J05AH02 1573722.06.2016

22.06.2021PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

4041 Tamoxifen tamoxifen

(tamoxifen citrate) tablets film-coated

20mg,


Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany L02BA01 1690308.08.2017

08.08.2022PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

4042

Tamoxifen 10mg

Film-Coated

Tablets

tamoxifen

(tamoxifen citrate)tablets film-coated

10mg,


CP Pharmaceuticals


Wrexham LL 13 9UF -


form manufacturer,


Limited, Survey No.

106/4-5-7, Kadaiya,

Nani Daman, IN-

396210, India)

UK L02BA01 1254001.06.2013

01.06.2018PoM

Wockhardt UK

Limited, Ash Road

North, Wrexham


13 9 UF, UK

894

4043

Tamoxifen 20mg

Film-Coated

Tablets

tamoxifen

(tamoxifen citrate)tablets film-coated

20mg,


CP Pharmaceuticals


Wrexham LL 13 9UF -


form manufacturer,


Limited, Survey No.

106/4-5-7, Kadaiya,

Nani Daman, IN-

396210, India)

UK L02BA01 1254101.06.2013

01.06.2018PoM

Wockhardt UK

Limited, Ash Road

North, Wrexham


13 9 UF, UK

4044 Tamoxifen Ebewetamoxifen

(tamoxifen citrate)tablets

20mg,


EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee - batch

releaser (Haupt

Pharma Amareg

GmbH, Donaustaufer

Strasse 378, 93055

Regensburg, Germany

- bulk manufacturer)

Austria L02BA01 1365808.07.2014

08.07.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

4045 Tamoxifen-Ebewetamoxifen

(tamoxifen citrate)tablets

10mg,


EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee-batch

releaser (Haupt

Pharma Amareg

GmbH, Donaustaufer

Strasse 378, 93055

Regensburg, Germany-

bulk manufacturer,

packager)

Austria L02BA01 1451515.05.2015

15.05.2020PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

895

4046 Tamsol

tamsulosin

(tamsulosin

hydrochloride)

capsules modified-

release

0,4mg,


30/3x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest- batch

releaser, Gedeon

Richter Romania S.A.,

99-105 Guza Voda

str., 540306, Targu-

Mures, Romania-bulk

manufacturer,

packager

Hungary G04CA02 1679622.06.2017

22.06.2022PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

4047 Tanakanginkgo biloba

extracttablets film-coated

40mg,


90/6x15/)

Beaufour Ipsen

Industrie , Ethe

Virton, 28100 Dreux

FranceN06DX02;

herbal drug14200

06.02.2015

06.02.2020OTC

Ipsen Pharma, 65

quai Georges Gorse,

92100 Boulogne-

Billancourt, France

4048 Tanakanginkgo biloba

extractsolution oral

40mg/ml,


graduated pipette 1ml

Beaufour Ipsen

Industrie, rue Ethe

Virton, 28100 Dreux

FranceN06DX02;

herbal drug 14461

04.05.2015

04.05.2020OTC

Ipsen Pharma, 65

quai Georges

Gorse,92100

Boulogne-Billancourt,

France

4049 Tantum Rosa

benzydamine

(benzydamine

hydrochloride)

solution vaginal100mg/100ml, 140ml

plastic bottle (5)

Aziende Chimiche

Riunite Angelini

Francesco A.C.R.A.F.

S.p.A., Via Vecchia

Del Pinocchio, 22-

60131 Ancona

Italy G02CC03 1538622.02.2016

22.02.2021OTC

Aziende Chimiche

Riunite Angelini


S.p.A. Viale Amelia,

70, Rome, Italy

4050 Tantum Rosa

benzydamine

(benzydamine

hydrochloride)

powder for vaginal

solution

500mg,

9,44g sachets (10)

Aziende Chimiche

Riunite Angelini


S.p.A., Via Vecchia

Del Pinocchio, 22-

60131 Ancona

Italy G02CC03 1538722.02.2016

22.02.2021OTC

Aziende Chimiche

Riunite Angelini



70, Rome, Italy

896

4051 Tantum Verde

benzydamine

(benzydamine

hydrochloride)

spray for local use

with mint flavor

0,255mg/dose

(150mg/100ml), 30ml

(176 doses) plastic

container with pump

dispenser

Aziende Chimiche

Riunite Angelini


S.p.A. Via Vecchiaa

Del Pinocchio, 22-

60131 Ancona

Italy A01AD02 1523825.12.2015

25.12.2020OTC

Aziende Chimiche

Riunite Angelini



70, Rome, Italy

4052 Tantum Verde

benzydamine

(benzydamine

hydrochloride)

solution for local use

with mint flavor

150mg/100ml, 120ml


cup

Aziende Chimiche

Riunite Angelini


S.p.A. Via Vecchiaa

Del Pinocchio, 22-

60131 Ancona

Italy A01AD02 1523925.12.2015

25.12.2020OTC

Aziende Chimiche

Riunite Angelini



70, Rome, Italy

4053 Tantum Verde

benzydamine

(benzydamine

hydrochloride)

lozenges3mg,

in pack (20/2x10/)

Aziende Chimiche

Riunite Angelini


S.p.A. Via Vecchiaa

Del Pinocchio, 22-

60131 Ancona

Italy A01AD02 15240/101.04.2016

25.12.2020OTC

Aziende Chimiche

Riunite Angelini



70, Rome, Italy

4054 Tardyferon iron sulfate tablets coated80mg,


Pierre Fabre

Medicament

Production,

Etablissement

Progipharm, Rue du

Lycee, 45500 Gien

France B03AA07 1356610.06.2014

10.06.2019PoM

Pierre Fabre

Medicament, 45,

Place Abel Gance,

92100 Boulogne,

France

4055 Tarka

trandolapril,

verapamil

(verapamil

hydrochloride)

tablets modified-

release film-coated

2mg+180mg,


AbbVie Deutschland

GmbH & Co. KG,

Knollstrasse, 67061

Ludwigshafen

Germany C09BB10 1470516.07.2015

16.07.2020PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

4056 Tarka

trandolapril,

verapamil

(verapamil

hydrochloride)

tablets modified-

release film-coated

4mg+240mg,


AbbVie Deutschland

GmbH & Co. KG,

Knollstrasse, 67061

Ludwigshafen

Germany C09BB10 1470616.07.2015

16.07.2020PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

897

4057 Tasigna nilotinib capsules

200mg,

in blister (28/7x4,

28/2x14/)

Novartis Pharma

Stein AG,


4332 Stein

Switzerland L01XE08 1360106.06.2014

06.06.2019PoM

Novartis Pharma AG,


Basel, Switzerland

4058 Tasigna

nilotinib (nilotinib

hydrochloride

monohydrate)

capsules hard150mg,


Novartis Pharma

Stein AG,


4332 Stein

Switzerland L01XE08 1548631.03.2016

31.03.2021PoM

Novartis Pharma AG,


Basel, Switzerland

4059 Taufone taurine drops eye40mg/ml,


Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01XA 15328

04.02.2016

04.02.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

4060 Taufon-Farmak taurine drops eye40mg/ml,

10ml plastic vial

PJSC "Farmak", 74

Frunze str., Kiev,

04080

Ukraine S01XA 1673705.06.2017

05.06.2022PoM

PJSC "Farmak", 63

Frunze str., Kiev,

04080, Ukraine

4061 Tautonus taurine drops eye40mg/ml, 10ml plastic

vial

Dosfarm LLP,

Chaplygin st. 3,

050034, Almaty

Kazakhstan S01XA 1303925.11.2013

25.11.2018PoM

Dosfarm LLP,

Chaplygin st. 3,

050034, Almaty,

Kazakhstan

4062 Tavanic

levofloxacin

(levofloxacin

hemihydrate)


in blister (5)

Sanofi Winthrop



Compiegne

France J01MA12 1526522.01.2016

22.01.2021PoM

Sanofi-Aventis

Deutschland GmbH,

D-65926 Frankfurt

am Main, Germany

4063 Tavanic

levofloxacin

(levofloxacin

hemihydrate)


in blister (5)

Sanofi Winthrop



Compiegne

France J01MA12 1526622.01.2016

22.01.2021PoM

Sanofi-Aventis

Deutschland GmbH,

D-65926 Frankfurt

am Main, Germany

898

4064 Tavanic

levofloxacin

(levofloxacin

hemihydrate)

solution for infusion 5mg/ml,

100ml glass bottle

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,

Bruningstrasse 50, D-

65926 , Frankfurt am

Main

Germany J01MA12 1687608.08.2017

08.08.2022PoM

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,



Main, Germany

4065 Tavegyl

clemastine

(clemastine

hydrofumarate)


1mg/ml,


(5)

Takeda Austria

GmbH, St. Peter

Strasse 25, A-4020

Linz

Austria R06AA04 12503/102.07.2014

01.06.2018PoM

Novartis Consumer


IÈtraz, 2 1260 Nyon,

Switzerland

4066 Tavegyl tablets clemastine tablets1mg,


Famar Italia S.p.A.,

Via Zambeletti 25,

20021 Baranzate di

Ballate

Italy D04AA14 1219601.02.2013

01.02.2018OTC

Novartis Consumer


l Etraz,1260 Nyon 1,

Switzerland

4067 Tavintenofovir disoproxil

fumaratetablets film-coated

300mg,


Emcure


Lane No. 3, Phase II,

SIDCO Industrial

Complex, Bari-

Brahmana, Jammu

(J&K)-181 133

India J05AF07 1662225.04.2017

25.04.2022PoM

Emcure


T-184, M.I.D.C.,

Bhosari, Pune-

411026, India

4068 Taxoteredocetaxe (docetaxel

trihydrate)

concentrate for


20mg/ml,

1ml concentrate in glass

vial 7ml

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,


65926 Frankfurt am

Main

Germany L01CD02 1345506.05.2014

06.05.2019PoM

Aventis Pharma S.A.,

20 avenue Raymond

Aron, 92165 Antony

Cedex, France

899

4069 Taxotere

docetaxel

(docetaxel

trihydrate)

concentrate for


20mg/ml,

4ml concentrate in glass

vial 7ml

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,


65926 Frankfurt am

Main

Germany L01CD02 1345606.05.2014

06.05.2019PoM

Aventis Pharma S.A.,

20 avenue Raymond

Aron, 92165 Antony

Cedex, France

4070 Tazepam oxazepam tablets film-coated10mg,


Tarchomin

Pharmaceutical

Works "Polfa" S.A.,


176 Warsaw

Poland N05BA04 1581620.07.2016

20.07.2021PoM/UC

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,


176 Warsaw, Poland

4071 TazPiTRONN

piperacillin

(piperacillin

sodium),

tazobactam

(tazobactam

sodium)

powder for solution

for injection/infusion

4000mg+500mg, 4,5g glass

vial (30ml)



Rabele, Thane-

Belapur Road, Navi

Mumbai Pin 400 701

India J01CR05 12149/113.05.2016

01.02.2018PoM


Limited, 205, P.N.

Kothari Industrial

Estate, L.B.S. Marg,

Bhandup (W),

Mumbai-400 078,

India

4072 Tears Naturale IIdextran (dextran

70), hypromellosedrops eye

1mg/ml+3mg/ml, 15ml

vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01XA20 1360006.06.2014

06.06.2019OTC

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

4073 Tebantin gabapentin capsules hard

300mg,


100/10x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N03AX12 1438216.04.2015

16.04.2020PoM

Gedeon Richter


21, 1103 Budapest,

Hungary

900

4074 Tebokanginkgo biloba dry


40mg,


60/3x20/)

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Str. 4, 76227

Karlsruhe

GermanyN06DX02;

herbal drug15614

24.05.2016

24.05.2021OTC

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Str. 4, 76227

Karlsruhe, Germany

4075 Tebokan forteginkgo biloba dry


120mg,


60/3x20/)

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Str. 4, 76227

Karlsruhe

GermanyN06DX02;

herbal drug15615

24.05.2016

24.05.2021OTC

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Str. 4, 76227

Karlsruhe, Germany

4076Teetha Teething

Gel

Chamomilla

recutita, Atropa

belladonna,

Aconitum napellus

gel oral12C/g+12C/g+ 12C/g,

15g aluminum tube

A Nelson and Co


Way, Wimbledon,

London SW19 8UH

UK

A01AD

homeopathic

drug

1351530.05.2014

30.05.2019PoM

A Nelson and Co


Way, Wimbledon,

London SW19 8UH,

UK

4077 Tegretol carbamazepine tablets200mg,




131, 80058 Torre

Annunziata (NA)

Italy N03AF01 1658103.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

4078 Telfast

fexofenadine

(fexofenadine

hydrochloride)



Sanofi-Synthelabo

Ltd., Edgefield

Avenue Fawdon,

Newcastle upon Tyne,

Tyne and Wear, NE3

3TT

UK R06AX26 1444604.05.2015

04.05.2020OTC

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,


65926 Frankfurt am

Main, Germany

4079Telmigrix 40mg

tabletstelmisartan tablets

40mg,


Laboratorios Lesvi

S.L., Avda. Barcelona

69, Sant Joan Despi,

Barcelona, 08970

Spain C09CA07 1645506.03.2017

06.03.2022PoM

Grindeks JSC,



901

4080Telmigrix 80mg

tabletstelmisartan tablets

80mg,


Laboratorios Lesvi

S.L., Avda. Barcelona

69, Sant Joan Despi,

Barcelona, 08970

Spain C09CA07 1645606.03.2017

06.03.2022PoM

Grindeks JSC,



4081 Telormin atenolol tablets coated50mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC07AB03 15775

29.06.2016

29.06.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

4082 Temodal temozolomide capsules

20mg,

in glass container (5),

sachets (5/1x5/)


N.V., Industriepark

30 B2220, Heist-op-

den-Berg - secondary

packager, batch

releaser (Orion

Pharma,

Tengstrominkatu 8, FI-

20360, Turku, Finland-

bulk manufacturer,

packager)

Belgium L01AX03 1336504.04.2014

04.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland, Belgium


100mg,


sachets (5/1x5/)


N.V., Industriepark

30 B2220, Heist-op-


packager, batch

releaser (Orion

Pharma,



bulk manufacturer,

packager)

Belgium L01AX03 1336604.04.2014

04.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

902


250mg,


sachets (5/1x5/)


N.V., Industriepark

30 B2220, Heist-op-


packager, batch

releaser (Orion

Pharma,



bulk manufacturer,

packager)

Belgium L01AX03 1336704.04.2014

04.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

4085 Temodal temozolomide capsules140mg,

in sachet (5)


N.V., Industriepark


den-Berg- batch

releaser, packager,

Orion Corporation /

Orion Pharma,


20360 Turku, Finland-

bulk manufacturer

Belgium L01AX03 1701726.09.2017

26.09.2022PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

4086 Temodal temozolomide capsules180mg,

in sachet (5)


N.V., Industriepark


den-Berg- batch

releaser, packager,

Orion Corporation /

Orion Pharma,


20360 Turku, Finland-

bulk manufacturer

Belgium L01AX03 1701826.09.2017

26.09.2022PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

903

4087 Tempalgin

metamizole

(metamizole

sodium),

triacetonamine 4-

toluensulfonate

tablets film-coated500mg+20mg; (20/2x10/)

in blister

Sopharma JSC,

Vrabevo vlg. 5660,

district of Lovetch

Bulgaria N02BB72 1707605.10.2017

05.10.2022OTC

Sopharma JSC, str.

Iliensko shosse 16,


4088 Tenikam tenoxicam

powder lyophilized

for solution for

injection

20mg,

glass vial (1) and 2ml

solvent in ampoule

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi-batch

releaser, secondary

packager, Anfarm

Hellas S.A., Sximatari

Viotias, 32009, Greece-

bulk manufacturer,

primary packager

Georgia M01AC02 1519730.12.2015

30.12.2020PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


4089 Tenol atenolol tablets50mg,


Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208

Bangladesh C07AB03 1363027.06.2014

27.06.2019PoM

Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208,

Bangladesh

4090 Tenoten

affinity purified

antibodies to brain

specific S-100

protein


3mg (not more than 10^-

15 ng/g),


40/2x20/)

NPF Materia Medica

Holding LLC, 54,


Chelyabinsk 454139

Russia

N05BX;

homeopathic

drug

1574404.07.2016

04.07.2021OTC

NPF Materia Medica


3rd Samotyochny


Russia

4091 Tenoten kids

affinity purified

antibodies to brain

specific S-100

protein


3mg (not more than 10^-

16 ng/g),


40/2x20/)

NPF Materia Medica

Holding LLC, 54,


Chelyabinsk 454139

Russia

N05BX;

homeopathic

drug

1574504.07.2016

04.07.2021OTC

NPF Materia Medica


3rd Samotyochny


Russia

904

4092 Tenox

amlodipine

(amlodipine

maleate)

tablets10mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C08CA01 1565608.06.2016

08.06.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4093 Tenox

amlodipine

(amlodipine

maleate)

tablets5mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C08CA01 1565708.06.2016

08.06.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4094 Teotard theophyllinecapsules modified-

release

200mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo


packager, Temmler

Ireland Limited,

Killorglin, County,

Kerry, Ireland- bulk

manufacturer

Slovenia R03DA04 1654403.04.2017

03.04.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4095 Teotard theophyllinecapsules modified-

release

350mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo


packager, Temmler

Ireland Limited,

Killorglin, County,

Kerry, Ireland- bulk

manufacturer

Slovenia R03DA04 1654503.04.2017

03.04.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

905

4096 Teqsatron

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for i/m and

i/v injection

8mg/4ml,


"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,


settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia A04AA01 1657603.04.2017

03.04.2022PoM

"Sotex"PharmFirm"


Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

4097 Teqsatron

ondansetron

(ondansetron

hydrochloride

dihydrate)


i/v injection

4mg/2ml,


"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,


settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia A04AA01 1657703.04.2017

03.04.2022PoM

"Sotex"PharmFirm"


Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

4098 Terbinafine

terbinafine

(terbinafine

hydrochloride)

tablets250mg,

in blister (10)

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30)

Belarus D01BA02 1296828.10.2013

28.10.2018PoM

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30,

Belarus)

4099 Terbinafine

terbinafine

(terbinafine

hydrochloride)

tablets125mg,

in blister (10)

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30)

Belarus D01BA02 1296928.10.2013

28.10.2018PoM

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30,

Belarus)

906

4100Terbinafine-

Asteria

terbinafine

(terbinafine

hydrochloride)

cream for external

use

10mg/g,

30g aluminium tube

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro,Jecheon-

Si, Chungcheongbuk-

do-batch releaser,

Dongkwang Pharm

Co., Ltd, 115, Sandan-

ro, Pyeongtaek-

si,Gyeonggi-do, Korea

South-bulk

manufacturer,

packager

Korea Sourth D01AE15 1479604.09.2015

04.09.2020OTC

GL Corporation,

Woori Venture

Tower 201,70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, Korea South

4101 Terbisil

terbinafine

(terbinafine

hydrochloride)

tablets

250mg,


28/2x14/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary D01BA02 1612310.11.2016

10.11.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

4102 Terbisil

terbinafine

(terbinafine

hydrochloride)

cream for external

use

10mg/g,

15g aluminium tube


Gyomroi ut 19-21,

1103 Budapest

Hungary D01AE15 1616823.11.2016

23.11.2021OTC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

4103 Tergynan

ternidazole,

neomycin

(neomycin sulfate),

nystatin,

prednisolone

(prednisolone

sodium

metasulphoben-

zoate)

tablets vaginal

200mg+65000IU+100000I

U+3mg, blister (6/1x6/,

10/1x10/)

Sophartex, 21 rue du

Pressoir, 28500

Vernouillet

France G01BA 14592/107.06.2016

08.06.2020PoM

Laboratoires

Bouchara-Recordati,

Immeuble le Wilson,

70 avenue du General

de Gaulle, 92800

Puteaux, France

4104 Termicon

terbinafine

(terbinafine

hydrochloride)

tablets250mg,


Pharmstandard-

Leksredstva JSC

(305022, Kursk,


1a/18)

Russia D01BA02 1293207.10.2013

07.10.2018PoM

Pharmstandard-

Leksredstva JSC

(305022, Kursk,


1a/18, Russia)

907

4105 Tessyron

clopidogrel

(clopidogrel

dihydrosulfate)

tablets film-coated

75mg,


28/2x14/)

Gedeon Richter

Romania S.A., 99-105

Guza Voda str.,

540306, Targu-Mures

Romania B01AC04 1521630.12.2015

30.12.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

4106 Testosteron depo

testosterone

(testosterone

enantate)

solution for i/m

injection

250mg/ml,

1ml ampoules (5)

Galenika a.d.,

Batajnicki drum bb,

11080 Belgrade -

batch releaser,

secondary packager,

Rotexmedica GmbH

Arzneimittelwerk,

Bunsenstrasse 4,

22946, Trittau,

Germany - bulk

manufacturer,

primary packager

Serbia G03BA03 1688108.08.2017

08.08.2022PoM

Galenika a.d.,

Batajnicki drum bb,

11080 Belgrade,

Serbia

4107 Tetagam Phuman tetanus

immunoglobulin

solution for i/m

injection

250IU/ml,

1ml glass prefilled syringe

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg

Germany J07AM01 1582920.07.2016

20.07.2021PoM

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg, Germany

4108 Tetracaine

tetracaine

(tetracaine

hydrochloride)

drops eye

10mg/ml,


(1, 10)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01HA03 17050

28.09.2017

20.09.2022PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

4109 Tetracyclin

tetracycline

(tetracycline

hydrochloride)

tablets film-coated

100mg,

in blister (20/2x10/)and


Biosintez OJSC,

Druzhby st. 4,

440033, Penza

Russia J01AA07 1385818.09.2014

18.09.2019PoM

Biosintez OJSC,

Druzhby st. 4,

440033, Penza, Russia

908

4110 Tetracycline tetracycline ointment eye10mg/g,

3g, 5g aluminium tube

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia S01AA09 1463603.07.2015

03.07.2020PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

4111 Tetracycline

tetracycline

(tetracycline

hydrochloride)

ointment for

external use

30mg/g,

15g aluminium tube

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia D06AA04 1484204.09.2015

04.09.2020PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

4112 Tetracycline

tetracycline

(tetracycline

hydrochloride)

tablets film-coated

100mg,

in blister (20/2x10,

40/4x10)

"Biohimik " PJSC,


430030, Saransk,

Vasenko str., 15A

Russia J01AA07 1683510.07.2017

10.07.2022PoM

"PROMOMED RUS "

LLC, 101000,

Moscow, Arkhangelsk


Russia

4113 Tetracycline

tetracycline

(tetracycline

hydrochloride)

capsules 250mg,


NOKI JV LTD Co.,

Nor-Kharberd, Ararat

region

Republic of

Armenia J01AA07 16920

08.08.2017

08.08.2022PoM

NOKI JV LTD Co.,


region, Republic of

Armenia

4114Tetracycline eye

ointment 1%tetracycline ointment eye

10mg/g,

3g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaS01AA09 14751

03.08.2015

03.08.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

4115Tetracycline-

Belmed

tetracycline

(tetracycline

hydrochloride)

tablets film-coated

100mg,


20/2x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Mayakovskogo St., 1

Belarus J01AA07 1611810.11.2016

10.11.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

909

4116 Teveten

eprosartan

(eprosartan

mesylate)



Abbott Healthcare

SAS, Route de


Maillard, 01400

Chatillon sur

Chalaronne

France C09CA02 1550719.04.2016

19.04.2021PoM

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

NL-1381 CP Weesp,

the Netherlands

4117 Theophylline KItheophylline,

potassium iodideelixir

80mg/15ml+

130mg/15ml, 100ml,

120ml glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaR03DA04 12517

01.06.2013

01.06.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Armenia

4118 Theraflex

glucosamine

(glucosamine

hydrochloride),

chondroitin sulfate


sodium)

capsules

500mg+400mg,


60, 120)

Contract Pharmacal

Corporation, 135

Adams avenue,

Hauppauge, New

York 11788

USA M09AX 1417821.01.2015

21.01.2020OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

4119 Theraflex Advance

glucosamine

(glucosamine

sulfate),

chondroitin sulfate


sodium), ibuprofen

capsules

250mg+200mg+ 100mg,


120)

Contract Pharmacal

Corporation, 135

Adams avenue,

Hauppauge, New

York 11788-batch

releaser, packager,

Contract Pharmacal

Corporation, 160

Commerce Drive

Hauppauge, New

York 11788, USA-

bulk manufacturer

USA M09AX 1656003.04.2017

03.04.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

910

4120 Theraflu

paracetamol,

pheniramine

(pheniramine

maleate),

phenylephrine

(phenylephrine

hydrochloride),

ascorbic acid

powder for oral

solution with lemon

flavour

325mg+20mg+

10mg+50mg, 22,1g

sachets (10)

Famar Orleans, 5

avenue de Concyr,

45071 Orleans Cedex

02

France N02BE51 1305225.11.2013

25.11.2018OTC

Novartis Consumer


I Etraz, 1260 Nyon,

Switzerland

4121 Theraflu

paracetamol,

pheniramine

(pheniramine

maleate),

phenylephrine

(phenylephrine

hydrochloride)

powder for oral

solution with forest

berries flavour

325mg+20mg+ 10mg,

11,5g sachets (10)

Novartis Consumer

Health Inc., 10401

Highway 6, Lincoln,

NE 68517

USA N02BE51 1662325.04.2017

25.04.2022OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

4122 TheraFlu BRO

rosemary oil,

eucalyptus

viminalis oil, Peru

balsam, racemic

camphor

ointment

50mg/g+50mg/g+

60mg/g+125mg/g, 40g

aluminum tube

Novartis Consumer



269, 1260 Nyon

SwitzerlandR05X

herbal drug 13401

14.04.2014

14.04.2019OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

4123 Theraflu Extra

paracetamol,

pheniramine

(pheniramine

maleate),

phenylephrine

(phenylephrine

hydrochloride),

ascorbic acid

powder for oral

solution (with apple

and cinnamon

flavour)

650mg+20mg+

10mg+50mg,

21,78g sachets (10)

Famar Orleans, 5

avenue de Concyr,

45071 Orleans, Cedex

2

France N02BE51 1336204.04.2014

04.04.2019OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

4124Theraflu Extra

Lemon

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

pheniramine

(pheniramine

maleate)

powder for oral

solution with lemon

flavour

(650mg+10mg+ 20mg),

15g sachets (10)

Famar Orleans, 5

avenue de Concyr,

45071 Orleans, Cedex

2

France N02BE51 1365408.07.2014

08.07.2019OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

911

4125 TheraFlu LAR

benzoxonium

chloride, lidocaine

(lidocaine

hydrochloride)

spray2mg/ml+1,5mg/ml, 30ml


Novartis Consumer

Health S.A. (Route de

IÈtraz, 1260 Nyon)


28.10.2018OTC

Novartis Consumer


IÈtraz, 1260 Nyon,

Switzerland)

4126 TheraFlu LAR

benzoxonium

chloride, lidocaine

(lidocaine

hydrochloride)

lozanges1mg+1mg,


Kemwell Biopharma

Pvt. Ltd., 34th km,

Tumkur Road, Village-

Teppada Begur,

Nelamangala,

Bangalore Rural,

562123

India R02AA20 1374324.07.2014

24.07.2019OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

4127 Thiamine chloridethiamine (thiamine

chloride)

solution for i/m

injection

50mg/ml,

1ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaA11DA01 13591

10.06.2014

10.06.2019PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

4128Thiamine chloride

(vitamin B1)

thiamine (thiamine

hydrochloride)solution for injection

50mg/ml,


ampoules in blister

(10/2x5/)

Lekhim-Kharkiv JSC,


str., 61115 Kharkov

Ukraine A11DA01 1440416.04.2015

16.04.2020PoM

Lekhim-Kharkiv JSC,



Ukraine

4129 Thioctacid 600 HRtioctic acid ( alfa-

lipoic acid)tablets film-coated

600mg,

in glass container (30,

100)

MEDA Pharma

GmbH & Co. KG,

Benzstrasse1, 61352

Bad Homburg - batch

releaser (bulk

manufacturer,

packager- MEDA

Manufacturing GmbH

Neurather Ring 1,

51063 Cologne,

Germany)

Germany A16AX01 14088/128.04.2015

16.12.2019PoM

MEDA Pharma

GmbH & Co. KG,

Germany

Benzstrasse1, 61352

Bad Homburg

912

4130 Thioctacid 600 T thioctic acid solution for injection25mg/ml,

24ml ampoules (5)

Hameln

Pharmaceutical

GmbH, Langes Feld

13, 31789 Hameln

Germany A16AX01 1260721.06.2013

21.06.2018PoM

MEDA Pharma

GmbH & Co. KG,

Benzstrasse 1, 61352

Bad Homburg,

Germany

4131 Thiogamma tioctic acid solution for infusion12mg/ml,

50ml glass vials (1, 10)

Solupharm

Pharmazeutische

Erzeugnisse GmbH,

Industriestrasse 3, D-

34212 Melsungen

Germany A16AX01 1399026.11.2014

26.11.2019PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer str. 7, 71034

Boblingen, Germany

4132 Thiogamma thioctic acid tablets film-coated

600mg,


60/6x10/)

Dragenopharm

Apotheker Puschl


84529 Tittmoning

Germany A16AX01 1600506.10.2016

06.10.2021PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

4133 Thiopentalthiopental

(thiopental sodium)

powder lyophilized


injection

500mg,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine N01AF03ղ 1603417.10.2016

17.10.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

4134 Thiopentalthiopental

(thiopental sodium)

powder lyophilized


injection

1000mg,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine N01AF03 1603517.10.2016

17.10.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

4135 Thiotriazolin tiotriazolin solution for injection

25mg/ml,


(10/1x10/)

Halychpharm JSC,


Opryshkovskaya, 6/8

Ukraine C01EB 1380105.09.2014

05.09.2019PoM

Halychpharm JSC,


Opryshkovskaya, 6/8,

Ukraine

913

4136 Thiotriazolin thiotriazoline solution for injection

25mg/ml,


(10/2x5/)

Halychpharm JSC,


Opryshkovskaya, 6/8

Ukraine C01EB 1380205.09.2014

05.09.2019PoM

Halychpharm JSC,


Opryshkovskaya, 6/8,

Ukraine

4137 Thiotriazolin thiotriazoline tablets200mg,


Kievmedpreparat

OJSC, 01032, Kiev,


139

Ukraine C01EB 1380305.09.2014

05.09.2019PoM

Kievmedpreparat

OJSC, 01032, Kiev,


139, Ukraine

4138 Thrombaspin acetylsalicylic acidtablets gastro-

resistant

100mg,


GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia B01AC06 1617023.11.2016

23.11.2021OTC

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


4139 Thromblessheparin (heparin

sodium)gel for external use

1000IU/g,

30g, 50g aluminium tube

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia C05BA03 1665511.05.2017

11.05.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

4140 Thrombo ASS acetylsalicylic acidtablets gastro-


100mg,


50/5x10/, 100/5x20/)

G.L. Pharma GmbH,

Schlossplatz 1, 8502

Lannach -batch

releaser, G.L. Pharma

GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria B01AC06 1538026.02.2016

26.02.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

4141 Thyrozol thiamazole tablets film-coated10mg,


Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03BB02 13750/127.03.2017

25.07.2019PoM

Merck KGaA,

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

914

4142 Thyrozol thiamazole tablets film-coated5mg,


Merck KGaA,

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03BB02 14466/127.03.2017

22.04.2020PoM

Merck KGaA,

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

4143 Tienam

imipenem

(imipenem

monohydrate),

cilastatin (cilastatin

sodium)

powder for solution

for infusion

500mg+500mg, glass vials

(10)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem - batch

releaser (Merck Sharp

& Dohme Corp., 2778

South East Highway,

Elkton, Virginia

22827, USA - bulk

manufacturer,

primary packager)

(Laboratoires Merck

Sharp & Dohme

Chibret, Mirabel

Plant, Route de

Marsat, Riom, 63963

Clermont-Ferrand

Cedex 9, France -

secondary packager)

the Netherlands J01DH51 12755/226.09.2014

14.08.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

4144 Timalinpolypeptides of

thymus

powder lyophilized


injection

10mg,

glass vials (10)

"Samson-Med" LLC,

Moscow highway, 13,

Saint Petersburg,

196158

Russia L03AX 1583320.07.2016

20.07.2021PoM

"Samson-Med" LLC,

Moscow highway, 13,

Saint Petersburg,

196158, Russia

4145 Timololtimolol (timolol

maleate)drops eye

5mg/ml,


S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania S01ED01 1624719.12.2016

19.12.2021PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

915

4146 Tinctura Crataegi fructus crataegi tincture100mg/ml,

30ml glass bottle

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

Armenia

C01EB04;

herbal drug13151

10.01.2014

10.01.2019OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

4147 Tinctura iodine 5% iodine tincture

50mg/ml,

10ml and 30ml glass

bottle

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaD08AG03 17253

12.12.2017

12.12.2022OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

4148 Tinctura Leonuri herba leonuri tincture200mg/ml,

30ml glass bottle

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaN05CM 13194

10.01.2014

10.01.2019OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

4149Tinctura menthae

piperitae

folium menthae

piperite, oil

menthae piperitae

tincture50mg/ml+ 50mg/ml; 30ml

glass bottle

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaA03AX 13242

24.02.2014

24.02.2019OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

4150 Tinidazol tinidazole tablets coated500mg,

in blister (4/1x4/, 16/4x4/)

Pharmaceutical

Works Polpharma


83-200 Starogard

Gdanski

Poland P01AB02 1587923.08.2016

23.08.2021PoM

Pharmaceutical

Works Polpharma



Gdanski, Poland

4151Tinidazol 500mg

film-coated tabletstinidazole tablets film-coated

500mg,

in blister (4/1x4/)

Balkanpharma-

Razgrad AD, 68,

Aprilsko vastanie

Blvd, 7200 Razgrad

Bulgaria P01AB02 1677422.06.2017

22.06.2022PoM

Balkanpharma-

Dupnitsa AD, 3,

Samokovsko shosse

str., 2600 Dupnitsa,

Bulgaria

916

4152 Tiodin

thiamine (thiamine

bromide), sodium

iodide

solution for i/m

injection

12,5mg/ml+ 10mg/ml,

5ml ampoules (10)

the Scientific

Technological Center

of Organic and

Pharmaceutical

Chemistry, A.L.

Mndjoyan Institute of

Fine Organic

Chemistry NAS RA ,

Yerevan, Azatutyun

avenue 26-batch

releaser (bulk

manufacturer,

packager-Yerevan

Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6, Republic of

Armenia)

Republic of

ArmeniaA11DA01 14045

19.12.2014

19.12.2019PoM

the Scientific

Technological Center

of Organic and

Pharmaceutical

Chemistry, A.L.

Mndjoyan Institute of

Fine Organic

Chemistry NAS RA ,

Yerevan, Azatutyun

avenue 26, Republic

of Armenia

4153 Tiregis telmisartan tablets coated20mg,

blisters (28/2x14)


PLC, 1165 Budapest,



(dosage form

manufacturer -

Glenmark Generics

Limited, Plot No. S-7,

Colvale Industrial

Estate, Colvale,

Bardez, Goa- 403 513,

India) (packager -

Glenmark

Pharmaceuticals s.r.o,

Fibichova 143, 566 17

Vysoke Myto, Czech

Republic)

Hungary C09CA07 13132/121.04.2016

10.01.2019PoM


PLC, 1106 Budapest,


Hungary

917


blisters (28/4x7/)


PLC, 1165 Budapest,



(dosage form

manufacturer -

Glenmark Generics


Colvale Industrial

Estate, Colvale,


India) (packager -

Glenmark



Vysoke Myto, Czech

Republic)

Hungary C09CA07 13133/121.04.2016

10.01.2019PoM


PLC, 1106 Budapest,


Hungary


blisters (28/4x7/)


PLC, 1165 Budapest,



(dosage form

manufacturer -

Glenmark Generics


Colvale Industrial

Estate, Colvale,


India) (packager -

Glenmark



Vysoke Myto, Czech

Republic)

Hungary C09CA07 13134/121.04.2016

10.01.2019PoM


PLC, 1106 Budapest,


Hungary

918

4156 Tiregis D

telmisartan,

hydrochlorothia-

zide

tablets

40mg+12,5mg,


56/4x14/)


PLC, 1165 Budapest,


120-batch releaser,


Bulebel Industrial

Estate, Zejtun, ZTN

3000, Malta-bulk

manufacturer,

packager

Hungary C09DA07 1462903.07.2015

03.07.2020PoM


PLC, 1106 Budapest,


Hungary

4157 Tiregis D

telmisartan,

hydrochlorothia-

zide

tablets

80mg+12,5mg,


56/4x14/)


PLC, 1165 Budapest,


120-batch releaser,


Bulebel Industrial

Estate, Zejtun, ZTN

3000, Malta-bulk

manufacturer,

packager

Hungary C09DA07 1463003.07.2015

03.07.2020PoM


PLC, 1106 Budapest,


Hungary

4158 Tiregis D

telmisartan,

hydrochlorothia-

zide

tablets

80mg+25mg,


(56/4x14/)


PLC, 1165 Budapest,


120-batch releaser,


Bulebel Industrial

Estate, Zejtun, ZTN

3000, Malta-bulk

manufacturer,

packager

Hungary C09DA07 1463103.07.2015

03.07.2020PoM


PLC, 1106 Budapest,


Hungary

919

4159 Tisercin levomepromazinesolution for injection

and infusion

25mg/ml,


(10/2x5/)


PLC, 1165 Budapest,


120

Hungary N05AA02 1603617.10.2016

17.10.2021PoM/UC


PLC, 1106 Budapest,


Hungary

4160 Tisercin

levomepromazine

(levomepromazine

maleate)




PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary N05AA02 1635730.12.2016

30.12.2021PoM/UC


PLC, 1106 Budapest,


Hungary

4161 Tivicay

dolutegravir

(dolutegravir

sodium)





09400 Aranda de

Duero, Burgos-batch

releaser, primary and

secondary packager,

Glaxo Wellcome,

S.A., Spain Avda.

Extremadura, 3 09400

Aranda De Duero,

Burgos-packager,

Glaxo Operations UK

Ltd, Priory street,


SG 12 0DT, UK-bulk

manufacturer

Spain J05AX12 1474703.08.2015

03.08.2020PoM

ViiV Healthcare UK

Ltd., 980 Great West

Road, Brentford,

Middlesex, TW8 9GS,

UK

4162 Tlocin-0,4

tamsulosin

(tamsulosin

hydrochloride)

capsules modified-

release, hard

0,4mg,



B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

for

India G04CA02 1511215.12.2015

15.12.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

920

4163 Tobradextobramycin,

dexamethasoneointment eye

3mg/g+1mg/g,

3,5g aluminium tube

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01CA01 1388106.10.2014

06.10.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

4164 Tobradextobramycin,

dexamethasone

drops eye

(suspension)

3mg/ml+1mg/ml, 5ml

plastic vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01CA01 1388206.10.2014

06.10.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

4165 Tobrex tobramycin drops eye (solution)3mg/ml,

5ml plastic vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01AA12 1388306.10.2014

06.10.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

4166 Tobrom tobramycin drops eye3mg/ml,

5ml plastic bottle-dropper

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania S01AA12 1638910.02.2017

10.02.2022PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

4167 Tonipazymlatex exsicco

papayaeae

powder lyophilized

for solution for

external use

35PU/ml,

10ml glass vial

Biopharm JSC, 3,

Gotua str., 380060,

Tbilisi

GeorgiaD03B;

herbal drug14196

06.02.2015

06.02.2020PoM

GPC JSC, 6, Sanapiro

str., 0108, Tbilisi,

Georgia

4168 Tonozolin

xylometazoline

(xylometazoline

hydrochloride)

drops nasal

0.5mg/ml,


dropper


Almaty city,

Chaplygin str.3

Kazakhstan R01AA07 1543302.04.2016

02.04.2021OTC


Almaty city,

Chaplygin str.3,

Kazakhstan

4169 Tonsilgon N

marshmallow root,

matricaria flowers,

horsetail herb,

walnut leaves,

yarrow herb, oak

bark, dandelion

herb

tablets coated

8mg+6mg+10mg+

12mg+4mg+4mg+ 4mg,


Bionorica SE,


15, 92318 Neumarkt

GermanyR02AA20;

herbal drug14574

09.06.2015

09.06.2020PoM

Bionorica SE,

Kerschensteinerstr.

11-15, 92318

Neumarkt, Germany

921

4170 Tonsilgon N

marshmallow root,

matricaria flowers,

horsetail herb,

walnut leaves,

yarrow herb, oak

bark, dandelion

herb

drops oral

4mg/g+3mg/g+

5mg/g+4mg/g+

4mg/g+2mg/g+ 4mg/g,

100ml glass container-

dropper

Bionorica SE,


15, 92318 Neumarkt

GermanyR02AA20;

herbal drug14575

09.06.2015

09.06.2020PoM

Bionorica SE,

Kerschensteinerstr.

11-15, 92318

Neumarkt, Germany

4171 Tonsilotren

atropinum

sulfuricum D5 trit.,

hepar sulfuris D3

trit., kalium

bichromicum D4

trit., silicea D2 trit.,

mercurius bijodatus

D8 trit.

tablets

12,5mg+10mg+

50mg+5mg+25mg, in

blister (60/3x20/)

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24 76227

Karlsruhe-batch

releaser, Dr. Willmar

Schwabe GmbH &

Co. KG, Willmar-

Schwabe-Str. 4, 76227

Karlsruhe, Germany-

bulk manufacturer,

packager

Germany

R02A;

homeopathic

drug

1458209.06.2015

09.06.2020OTC

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe, Germany

4172 Topamax topiramate capsules25mg,




Borgo S. Michele,

Latina-batch releaser,

packager, Janssen-

Ortho LLC, State

Road 933 KM 0.1 ,

Mamey Ward,

Gurabo, Puerto Rico

(PR) 00778, USA-bulk

manufacturer

Italy N03AX11 1642420.02.2017

20.02.2022PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

922

4173 Topamax topiramate capsules50mg,




Borgo S. Michele,

Latina-batch releaser,

packager, Janssen-

Ortho LLC, State

Road 933 KM 0.1 ,

Mamey Ward,

Gurabo, Puerto Rico

(PR) 00778, USA-bulk

manufacturer

Italy N03AX11 1642520.02.2017

20.02.2022PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

4174 Topepsil topiramate tablets coated25mg,



PLC, 1165 Budapest,


120 - packager, batch

releaser (Generis

Farmaceutica, S.A.,

Rua Joao de Deus, N

19, Venda Nova, 2700-

487 Amadora,

Portugal - bulk

manufacturer)

Hungary N03AX11 1384118.09.2014

18.09.2019PoM


PLC, 1106 Budapest,


Hungary




PLC, 1165 Budapest,



releaser (Generis

Farmaceutica, S.A.,

Rua Joao de Deus, N


487 Amadora,

Portugal - bulk

manufacturer)

Hungary N03AX11 1384218.09.2014

18.09.2019PoM


PLC, 1106 Budapest,


Hungary

923




PLC, 1165 Budapest,



releaser (Generis

Farmaceutica, S.A.,

Rua Joao de Deus, N


487 Amadora,

Portugal - bulk

manufacturer)

Hungary N03AX11 1384318.09.2014

18.09.2019PoM


PLC, 1106 Budapest,


Hungary




PLC, 1165 Budapest,



releaser (Generis

Farmaceutica, S.A.,

Rua Joao de Deus, N


487 Amadora,

Portugal - bulk

manufacturer)

Hungary N03AX11 1384418.09.2014

18.09.2019PoM


PLC, 1106 Budapest,


Hungary

4178 Topiramate Canon topiramate tablets film-coated25mg,


CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N03AX11 1643806.03.2017

06.03.2022PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

4179 Topiramate Canon topiramate tablets film-coated100mg,


CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N03AX11 1643906.03.2017

06.03.2022PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

924

4180Toramat 25mg

tabletstopiramate tablets film-coated

25mg,


Pharmathen S.A.,


Pallini, Attiki

Greece N03AX11 1388806.10.2014

06.10.2019PoM

Pharmathen S.A.,



4181Toramat 50mg

tabletstopiramate tablets film-coated

50mg,


Pharmathen S.A.,


Pallini, Attiki

Greece N03AX11 1388906.10.2014

06.10.2019PoM

Pharmathen S.A.,



4182 Toras-Denk 10 torasemide tablets10mg,


Denk Pharma GmbH


84529 Tittmoning

Germany C03CA04 1336004.04.2014

04.04.2019PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

4183 Toras-Denk 5 torasemide tablets5mg,


Denk Pharma GmbH


84529 Tittmoning

Germany C03CA04 1622805.12.2016

05.12.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

4184 Torvazin

atorvastatin

(atorvastatin

calcium)




PLC, 1165 Budapest,


120

Hungary C10AA05 1576404.07.2016

04.07.2021PoM


PLC, 1106 Budapest,


Hungary

4185 Torvazin

atorvastatin

(atorvastatin

calcium)




PLC, 1165 Budapest,


120

Hungary C10AA05 1576504.07.2016

04.07.2021PoM


PLC, 1106 Budapest,


Hungary

925

4186 Torvazin

atorvastatin

(atorvastatin

calcium)




PLC, 1165 Budapest,


120

Hungary C10AA05 1576604.07.2016

04.07.2021PoM


PLC, 1106 Budapest,


Hungary

4187 Tot'Hema

iron (iron

gluconate),

manganese

(manganese

gluconate), copper

(copper gluconate)

solution oral

50mg/10ml+

1,33mg/10ml+

0,7mg/10ml,


Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France B03AA03 1409718.12.2014

18.12.2019PoM


International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

4188 Trachisan


hydrochloride),

chlorhexidine

(chlorhexidine

digluconate)

gargle solution1mg/ml+2mg/ml, 200ml

glass bottle

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden

Germany R02A 1634230.12.2016

30.12.2021OTC

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden,

Germany

4189 Trachisan Lozenges


hydrochloride),

chlorhexidine

(chlorhexidine

digluconate),

tyrothricin

lozenges1mg+1mg+0.5mg, in

blister (20/2x10/)

Engelhard

Arzneimittel GmbH

& Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden

Germany R02A 1561924.05.2016

24.05.2021OTC

Engelhard

Arzneimittel GmbH

& Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden,

Germany

4190 Tramadoltramadol (tramadol


50mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia N02AX02 1655203.04.2017

03.04.2022PoM/UC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4191 Tramadoltramadol (tramadol


100mg/2ml,

2ml ampoules (5)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia N02AX02 1662425.04.2017

25.04.2022PoM/UC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

926

4192 Tramadol Alkaloidtramadol (tramadol


100mg/2ml,

2ml ampoules (5)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N02AX02 1712023.10.2017

23.10.2022PoM/UC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

4193 Tramadol Alkaloidtramadol (tramadol


50mg,

in glass bottle (20)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N02AX02 1715407.11.2017

07.11.2022PoM/UC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

4194 Tramadol Denk 50tramadol (tramadol

hydrochloride)tablets effervescent

50mg,


Losan Pharma GmbH

Otto- Hahn-Str. 13

79395 Neuenburg

Germany N02AX02 1416029.12.2014

29.12.2019PoM/UC

Denk Pharma GmbH

& Co. KG, Germany

Prinzergentenstr. 79,

81675 Munchen

4195

Tramadol Kalceks

100mg/2ml

solution for

injection

tramadol (tramadol


100mg/2ml,

2ml ampoules (5/1x5/,

10/2x5/)

Kalceks JSC, 53


LV-1057- batch

releaser, HBM

Pharma s.r.o.,



manufacturer,

packager

Latvia N02AX02 1674105.06.2017

05.06.2022PoM/UC

Kalceks JSC, 53


LV-1057, Latvia

4196 Tramadol-Mtramadol (tramadol


50mg/ml,


10/2x5/)

"KPE" Zdorovje

narodu" Ltd., 61013,

Kharkov,Sevchenko

str. 22

Ukraine N02AX02 1285417.09.2013

17.09.2018PoM/UC

"KPE" Zdorovje


Kharkov,Sevchenko

str. 22, Ukraine

927

4197 Tramadol-ZNtramadol (tramadol


50mg,


20/2x10/)

"KPE" Zdorovje


Kharkov,Sevchenko

str. 22

Ukraine N02AX02 1304425.11.2013

25.11.2018PoM/UC

"KPE" Zdorovje


Kharkov,Sevchenko

str. 22, Ukraine

4198 Tranexam tranexamic acidsolution for i/v

infusion

50mg/ml,


Moscow Endocrine

Plant FSUE, 25,

Novokhokhlovskaya

st., Moscow 109052

Russia B02AA02 13019/123.12.2016

25.11.2018PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

4199 Tranexam tranexamic acid tablets film-coated

250mg,

blister (10/1x10/), blisters

(30/3x10/)

Obninsk Chemical

Pharmaceutical

Company CJSC,

249036, Kaluga

region, Obninsk,

Kievskoye shosse, bld.

103, bld. 107

Russia B02AA02 13259/223.12.2016

24.02.2019PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

4200 Tranexam tranexamic acid tablets film-coated500mg,

blister (10)

Obninsk Chemical

Pharmaceutical

Company CJSC,

249036, Kaluga

region, Obninsk,

Kievskoye shosse, bld.

103, bld. 107

Russia B02AA02 13260/123.12.2016

24.09.2019PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

4201 Transulosa

lactulose, soft

paraffin, liquid

paraffin

gel oral

350mg/g+ 214,5mg/g+

429,1mg/g,

150g plastic container

and measuring spoon

Laboratoires

CHEMINEAU, 93,

route de Monnaie,

37210 Vouvray

France A06AD61 1577611.07.2016

11.07.2021OTC

Laboratoires

MAYOLY

SPINDLER, 6 avenue

de l Europe, 78400

Chatou, France

928

4202 Traumeel

achillea millefolium

D3, napellus D2,

arnica montana D2,

atropa bella-donna

D2, bellis perennis

D2, calendula

officinalis D2,

echinacea D2,

echinacea purpurea

D2, hamamelis

virginiana D1,

hepar sulfuris D6,

hypericum

perforatum D2,

matricaria recutita

D3, mercurius

solubilis

Hahnemanni D6,

symphytum

officinale D6


2.2mg/2.2ml+

1.32mg/2.2ml+

2.2mg/2.2ml+

2.2mg/2.2ml+

1.1mg/2.2ml+

2.2mg/2.2ml+

0.55mg/2.2ml+

0.55mg/2.2ml+

0.22mg/2.2ml+

2.2mg/2.2ml+

0.66mg/2.2ml+

2.2mg/2.2ml+

1.1mg/2.2ml+

2.2mg/2.2ml, 2.2ml

ampoules (10, 100)

Biologische Heilmittel

Heel GmbH, Dr.-

Reckeweg-Strasse 2-4,

76532 Baden-Baden

Germany

M09AX;

հոմեոպաթա

յին դեղ

1531104.02.2016

04.02.2021PoM

Biologische

Heilmittel Heel

GmbH, Dr.-

Reckeweg-Strasse 2-

4, 76532 Baden-

Baden, Germany

4203 Traumeel

achillea millefolium

MT, aconitum

napellus D1, arnica

montana D3, atropa

bella-donna D1,

bellis perennis MT,

calendula officinalis

MT, echinacea MT,

echinacea purpurea

MT,hamamelis

virginiana MT,

hepar sulfuris D6,

hypericum

perforatum D6,

matricaria recutita

MT, mercurius

solubilis

Hahnemanni D6,

symphytum

officinale D4

ointment

0.9mg/g+0.5mg/g+15mg/g

+0.5mg/g+

1mg/g+4.5mg/g+

1.5mg/g+1.5mg/g+4.5mg/

g+0.25mg/g+0.9mg/g+1.5

mg/g+0.4mg/g+1mg/g,

50g aluminium tube

Biologische Heilmittel

Heel GmbH, Dr.-

Reckeweg-Strasse 2-4,

76532 Baden-Baden

Germany

M09AX;

homeopathic

drug

1531204.02.2016

04.02.2021OTC

Biologische

Heilmittel Heel

GmbH, Dr.-

Reckeweg-Strasse 2-

4, 76532 Baden-

Baden, Germany

929

4204Travapress

Rompharmtravoprost eye drops

0,04mg/ml,

2.5ml plastic vial

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania S01EE04 1695505.09.2017

05.09.2022PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

4205 Travatan travoprost drops eye (solution)40mcg/ml,

2,5ml vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01EE04 1355406.06.2014

06.06.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

4206 Travella

Apomorph,

Staphisagria,

Cocculus,

Theridion,

Petroleum,

Tabacum, Nux

vomica

tablets

6C+6C+6C+6C+6C+6C+6

C,


A Nelson and Co


Way, Wimbledon,

London SW19 8UH

UK

A04AD

homeopathic

drug

1351330.05.2014

30.05.2019PoM

A Nelson and Co


Way, Wimbledon,

London SW19 8UH,

UK

4207 Travisil

adatoda vasika,

piper longum, piper

nigrum, zingiber

officinale,

glycyrrhiza glabra,

emblica officinalis,

curcuma longa,

acacia catechu,

foeniculum vulgare,

ocimum sanctum,

terminalia chebula,

terminalia belerica,

alpinia galangal,

abrus precatorius,

menthol

syrup

5mg/5ml+ 25mg//5ml+

20mg/5ml+ 12mg/5ml+

10mg/5ml+ 16mg/5ml+

15mg/5ml+ 17mg/5ml+

18mg/5ml+ 5mg/5ml+

5mg/5ml+ 5mg/5ml+

20mg/5ml+ 20mg/5ml+

2mg/5ml, 100ml plastic

bottle

Plethico


(Dharavara, Kalaria-

453001, Indore /MP/)

IndiaR05CA10;

herbal drug12938

07.10.2013

07.10.2018OTC

Plethico



453001, Indore /MP/,

India)

930

4208 Travisil

adatoda vasika,

piper longum, piper

nigrum, zingiber

officinale,

glycyrrhiza glabra,


curcuma longa,

acacia catechu,

foeniculum vulgare,

ocimum sanctum,

terminalia chebula,


alpinia galangal,

abrus precatorius,

menthol

lozenges with honey

flavour

5mg+25mg+20mg+12mg+

10mg+ 16mg+15mg+

17mg+18mg+5mg+5mg+5

mg+20mg+ 20mg+2mg,

in strip (16/2x8/)

Plethico




IndiaR05CA10;

herbal drug12939

07.10.2013

07.10.2018OTC

Plethico




India)

4209 Travisil

adatoda vasika,

piper longum, piper

nigrum, zingiber

officinale,

glycyrrhiza glabra,


curcuma longa,

acacia catechu,

foeniculum vulgare,

ocimum sanctum,

terminalia chebula,


alpinia galangal,

abrus precatorius,

menthol

lozenges with mint

flavour

5mg+25mg+20mg+12mg+

10mg+ 16mg+15mg+

17mg+18mg+

5mg+5mg+5mg+

20mg+20mg+2mg, in

strip (16/2x8/)

Plethico




IndiaR05CA10;

herbal drug12940

07.10.2013

07.10.2018OTC

Plethico




India)

931

4210 Travisil

adatoda vasika,

piper longum, piper

nigrum, zingiber

officinale,

glycyrrhiza glabra,


curcuma longa,

acacia catechu,

foeniculum vulgare,

ocimum sanctum,

terminalia chebula,


alpinia galangal,

abrus precatorius,

menthol

lozenges with lemon

flavour

5mg+25mg+20mg+12mg+

10mg+ 16mg+15mg+

17mg+18mg+

5mg+5mg+5mg+

20mg+20mg+2mg, in

strip (16/2x8/)

Plethico




IndiaR05CA10;

herbal drug12941

07.10.2013

07.10.2018OTC

Plethico




India)

4211 Travisil

adatoda vasika,

piper longum, piper

nigrum, zingiber

officinale,

glycyrrhiza glabra,


curcuma longa,

acacia catechu,

foeniculum vulgare,

ocimum sanctum,

terminalia chebula,


alpinia galangal,

abrus precatorius,

menthol

lozenges with orange

flavour

5mg+25mg+20mg+12mg+

10mg+ 16mg+15mg+

17mg+18mg+5mg+5mg+5

mg+20mg+ 20mg+2mg,

in strip (16/2x8/)

Plethico




IndiaR05CA10;

herbal drug12942

07.10.2013

07.10.2018OTC

Plethico




India)

4212 Travocort

isoconazole

(isoconazole

nitrate),

diflucortolone

(diflucortolone

valerate)

cream for external

use

10mg/g+1mg/g, 15g

aluminium tube

Bayer Healthcare


Via E. Schering 21,

20090 Segrate

(Milano)

Italy D07XC04 1483604.09.2015

04.09.2020PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

932

4213 Travogenisoconazole

(isoconazole nitrate)

cream for external

use

10mg/g,

20g aluminium tube

Bayer Healthcare


Via E. Schering 21,

20090 Segrate

(Milano)

Italy D01AC05 1483704.09.2015

04.09.2020PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

4214 Trental pentoxifyllinetablets enteric film-

coated

100mg,


Sanofi India Limited,

Plot No.-3501, 3503-

15, 6310B-14,

G.I.D.C. ESTATE,

Post Box No 136,

Ankleshwar, Bharuch

India C04AD03 15236/104.05.2017

23.12.2020PoM

Sanofi India Limited,

54/A, Sir Mathuradas

Vasanji Road,

Andheri (East)

Mumbai 400093,

India

4215 Tresiba FlexTouch insulin degludec solution for injection100U/ml,

3ml pre-filled pens (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd-batch

releaser, bulk

manufacturer,

primary packager,

Novo Nordisk A/S,

Brennum Park,

Hillerod,3400,

Denmark- secondary

packager

Denmark A10AE06 1674405.06.2017

05.06.2022PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

4216 Tribestantribulus terrestris

herb dry extracttablets film-coated

250mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

BulgariaG04BX;

herbal drug14583

09.06.2015

09.06.2020OTC

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

4217 Tribux

trimebutine

(trimebutine

maleate)

tablets

100mg,


30/3x10/, 60/6x10/)

Biofarm Sp. z o.o., 13,

Walbrzyska Str., 60-

198, Poznan

Poland A03AA05 1513823.12.2015

11.12.2020PoM

Biofarm Sp. z o.o., 13,

Walbrzyska Str., 60-

198, Poznan, Poland

933

4218Trichopol

Polpharmametronidazole tablets

250mg,


Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland P01AB01 16060/120.05.2017

17.10.2021PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski, Poland

4219 Tricor fenofibrate tablets film-coated145mg,


Recipharm Fontaine,

Rue des Pres Potets,

21121 Fontaine les

Dijon - packager,


form manufacturer -

Fournier Laboratories

Ireland Limited,

Annagrove,

Carrigtwohill, Co.

Cork, Ireland)

France C10AB05 1226507.03.2013

07.03.2018PoM

Laboratoires Fournier

S.A., 28 Boulevard

Clemenceau, 21000

Dijon, France

4220 Triderm

betamethasone

(betamethasone

dipropionate),

clotrimazole,

gentamicin

(gentamicin sulfate)

ointment0,5mg/g+10mg/g+ 1mg/g,

15g aluminium tube


N.V., Industriepark


den-Berg

Belgium D07CC01 13022/127.03.2015

25.11.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

4221 Triderm

betamethasone

(betamethasone

dipropionate),

clotrimazole,

gentamicin

(gentamicin sulfate)

cream0,5mg/g+10mg/g+ 1mg/g,

15g aluminium tube


N.V., Industriepark


den-Berg

Belgium D07CC01 1349930.05.2014

30.05.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

4222 Triftazine

trifluoperazine

(trifluoperazine

hydrochloride)

tablets coated5mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05AB06 14082

16.12.2014

16.12.2019PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

934

4223 Trigrim torasemide tablets5mg,


Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland C03CA04 1600706.10.2016

06.10.2021PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski, Poland

4224 Trigrim torasemide tablets2,5mg,


Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland C03CA04 1600806.10.2016

06.10.2021PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski, Poland

4225 Trigrim torasemide tablets10mg,


Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland C03CA04 1600906.10.2016

06.10.2021PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski, Poland

4226 Trimecor MR

trimetazidine

(trimetazidine

dihydrochloride)

tablets film-coated

modified-release

35mg,


60/6x10/)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia C01EB15 1522030.12.2015

30.12.2020PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


4227 Trimetabol

sachet-

cyproheptadine

(cyproheptadine

acefyllinate

micronized),

thiamine (thiamine

hydrochloride),

pyridoxine

hydrochloride,

cyanocobalamin,

solution-L-lysine

(lysine

hydrochloride), DL-

carnitine

hydrochloride

powder for oral

solution

52.5mg+900mg+

900mg+30mg,

50mg/ml+75mg/ml, 3g

sachet (1) and 150ml

plastic container

J. Uriach & Cia., S.A.

Av. Cami Reial, 51-

57, 08184 Palau-Solita

i Plegamans,

Barcelona-sachet

manufacturer,

Italfarmaco S.A.,

C/San Rafael, 3, Pol.

Ind. Alcobendas,

Alcobendas, Madrid,

28108-solution

manufacturer

Spain 14903/107.12.2015

24.09.2020OTC

J. Uriach & Cia., S.A.

Av. Cami Reial, 51-

57, 08184 Palau-Solita

i Plegamans,

Barcelona, Spain

935

4228 Trimetox 240sulfadoxine,

trimethoprimsolution for injection

200mg/ml+ 40mg/ml,

100ml and 250ml glass

vial

Veyx-Pharma GmbH,

Sohreweg 6, 34639

Schwarzenborn-

batch releaser,

secondary packager,

VEYX PHARMA

B.V., Forellenweg 16,

Raamsdonksveer,

4941SJ, the

Netherlandsy- bulk

manufacturer,

primary packager

Germany

QJ01EW13;

veterinary

drug

1701226.09.2017

26.09.2022PoM

Veyx-Pharma GmbH,

Sohreweg 6, 34639

Schwarzenborn,

Germany

4229 Triovit

beta-carotine, alfa-

tocopherol acetate,

ascorbic acid, selen

capsules

10mg+40mg+

100mg+50mcg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A11AA03 1702726.09.2017

26.09.2022OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4230Triphthazin-

Zdorovye

trifluoperazine

(trifluoperazine

hydrochloride)

tablets film-coated

5mg,


50/5x10/, 50/2x25/),


Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine N05AB06 1656703.04.2017

03.04.2022PoM/UC

Pharmaceutical

Company "Zdorovye"



Ukraine

4231 Triplixam

perindopril

(perindopril

arginine),

indapamide,

amlodipine

(amlodipine

besilate)

tablets film-coated2,5mg+0,625mg+ 5mg,


Servier (Ireland)


Road, Arklow-Co

Wicklow

Ireland C09BX01 1378205.09.2014

05.09.2019PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

4232 Triplixam

perindopril

(perindopril

arginine),

indapamide,

amlodipine

(amlodipine

besilate)

tablets film-coated5mg+1,25mg+5mg, in


Servier (Ireland)


Road, Arklow-Co

Wicklow

Ireland C09BX01 1378305.09.2014

05.09.2019PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

936

4233 Triplixam

perindopril

(perindopril

arginine),

indapamide,

amlodipine

(amlodipine

besilate)

tablets film-coated5mg+1,25mg+ 10mg,


Servier (Ireland)


Road, Arklow-Co

Wicklow

Ireland C09BX01 1378405.09.2014

05.09.2019PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

4234 Triplixam

perindopril

(perindopril

arginine),

indapamide,

amlodipine

(amlodipine

besilate)

tablets film-coated10mg+2,5mg+5mg, in


Servier (Ireland)


Road, Arklow-Co

Wicklow

Ireland C09BX01 1378505.09.2014

05.09.2019PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

4235 Triplixam

perindopril

(perindopril

arginine),

indapamide,

amlodipine

(amlodipine

besilate)

tablets film-coated10mg+2,5mg+ 10mg,


Servier (Ireland)


Road, Arklow-Co

Wicklow

Ireland C09BX01 1378605.09.2014

05.09.2019PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

4236 Tri-Regolethinylestradiol,

levonorgestreltablets film-coated

I-0,03mg+0,05mg, II-

0,04mg+0,075mg, III-

0,03mg+0,125mg, in

blister (21(6(I)+5(II)+

10(III)), (63(/3x21/6(I)+

5(II)+10(III)/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AB03 1493720.10.2015

20.10.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

4237 Tritace ramipril tablets5mg,

in blister (28/2x14.)

Sanofi-Aventis S.p.A.,

Strada Statale N17-

km22, 67019 Scoppito

Italy C09AA05 1508915.12.2015

15.12.2020PoM

Sanofi-Aventis

Deutschland GmbH,

D-65926 Frankfurt

am Main, Germany

937

4238 Tritace ramipril tablets10mg,



Strada Statale N17-


Italy C09AA05 1509015.12.2015

15.12.2020PoM

Sanofi-Aventis

Deutschland GmbH,

D-65926 Frankfurt

am Main, Germany

4239 Tritace ramipril tablets2,5mg,

in blister (28/2x14.)


Strada Statale N17-


Italy C09AA05 1509115.12.2015

15.12.2020PoM

Sanofi-Aventis

Deutschland GmbH,

D-65926 Frankfurt

am Main, Germany

4240 Tritace comp

ramipril,

hydrochlorothia-

zide

tablets5mg+25mg,



Strada Statale N17-


Italy C09BA05 1496818.11.2015

18.11.2020PoM

Sanofi-Aventis

Deutschland GmbH,

D-65926 Frankfurt

am Main, Germany

4241 Trittico trazodonetablets prolonged-

release

150mg,


60/6x10/)

Aziende Chimiche

Riunite Angelini


S.p.A. Via Vecchiaa

Del Pinocchio, 22-

60131 Ancona (AN))

Italy N06AX05 1413029.12.2014

29.12.2019PoM

Aziende Chimiche

Riunite Angelini



70, Rome (RM))

4242 Trittico trazodonetablets prolonged-

release

75mg,


Aziende Chimiche

Riunite Angelini


S.p.A. Via Vecchiaa

Del Pinocchio, 22-

60131 Ancona (AN))

Italy N06AX05 1413129.12.2014

29.12.2019PoM

Aziende Chimiche

Riunite Angelini



70, Rome (RM))

938

4243 Triumeq

dolutegravir

(dolutegravir

sodium), abacavir

(abacavir sulfate),

lamivudine

tablets film-coated50mg+600mg+ 300mg,



Avenida

Extremadura, 3,

09400 Aranda de

Duero, Burgos- batch

releaser, packager,

Glaxo Operations UK

Ltd, Priory Street,

Ware, Hertfordshire

SG12 0DJ, UK-bulk

manufacturer

Spain J05AR13մ 1614923.11.2016

23.11.2021PoM

ViiV Healthcare UK

Ltd., 980 Great West

Road, Brentford,

Middlesex, TW8 9GS,

UK

4244

TRO-

AMOXICLAV

625mg film-coated

tablets

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)



Medopharm Private

Limited, No. 50

Kayarambedu Village,

Guduvanchery,

Chennai-603202

India J01CR02 1666711.05.2017

11.05.2022PoM

Troge Medical

GmbH, Milchstrasse

19, 20148 Hamburg,

Germany

4245

TROGE Ibuprofen

200mg film-coated

tablets

ibuprofen tablets film-coated200mg,


Medopharm, No. 34-

B, Industrial Area,

Malur-563 130,

Karnataka

India M01AE01 1363127.06.2014

27.06.2019OTC

Troge Medical

GmbH, Milchstrasse

19, D-20148

Hamburg, Germany

4246

TROGE Ibuprofen

400mg film-coated

tablets

ibuprofen tablets film-coated400mg,


Medopharm, No. 34-

B, Industrial Area,

Malur-563 130,

Karnataka

India M01AE01 1363227.06.2014

27.06.2019OTC

Troge Medical

GmbH, Milchstrasse

19, D-20148

Hamburg, Germany

4247

TROGE

PARACETAMOL

500mg tablets

paracetamol tablets500mg,


Medopharm, No. 34-

B, Industrial Area,

Malur-563 130,

Karnataka

India N02BE01 1663925.04.2017

25.04.2022OTC

Troge Medical

GmbH, Milchstrasse

19, 20148 Hamburg,

Germany

939

4248Trombopol

Polpharmaacetylsalicylic acid

tablets gastro-

resistant coated

75mg,


60/6x10/)

Pharmaceutical

Works Polpharma

S.A., ul. Pelplinska19,

83-200 Starogard

Gdanski

Poland B01AC06 15057/124.07.2017

02.12.2020OTC

Pharmaceutical

Works Polpharma


83-200 Starogard

Gdanski, Poland

4249Trombopol

Polpharmaacetylsalicylic acid

tablets gastro-

resistant coated

150mg,


60/6x10/)

Pharmaceutical

Works Polpharma


83-200 Starogard

Gdanski

Poland B01AC06 15058/124.07.2017

02.12.2020OTC

Pharmaceutical

Works Polpharma


83-200 Starogard

Gdanski, Poland

4250TRO-VIAGILE

100mg



100mg,

in blister (4/1x4/), box

(30)

S Kant Healthcare

LTD, Plot 1802-1805,

GIDC Phase III, Vapi -

396 195

India G04BE03 1660110.04.2017

10.04.2022PoM

Troge Medical

GmbH, Milchstrasse

19, 20148 Hamburg,

Germany

4251Troxerutin

Adipharmtroxerutin capsules

300mg,


ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700

Bulgaria C05CA04 1284617.09.2013

17.09.2018OTC

ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700, Bulgaria

4252Troxerutin

Sopharma 2% geltroxerutin gel

20mg/g,

40g aluminium tube

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia - batch

releaser, Sopharma

JSC, Vrabevo vlg.

5660, district of

Lovetch, Bulgaria-

bulk manufacturer,

packager

Bulgaria C05CA04 1543702.04.2016

02.04.2021OTC

Sopharma JSC, str.

Iliensko shosse 16,


4253

Troxerutin

Sopharma 300mg

capsules hard

troxerutin capsules hard300mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria C05CA04 1646706.03.2017

06.03.2022OTC

Sopharma JSC, str.

Iliensko shosse 16,


940

4254 Troxevasin 2% troxerutin gel for external use

20mg/g,


tube

Balkanpharma-

Troyan AD,

Krayrechna Str. N1,

5600, Troyan

Bulgaria C05CA04 1658003.04.2017

03.04.2022OTC

Balkanpharma-

Troyan AD,

(ACTAVIS GROUP)

Krayrechna Str. N1,

5600, Troyan,

Bulgaria

4255Troxevasin 300mg

hard capsulestroxerutin capsules hard

300mg,


Balkanpharma-

Razgrad AD, 68

Aprilsko Vastanie

Blvd, 7200 Razgrad

Bulgaria C05CA04 1620508.12.2016

08.12.2021OTC

Balkanpharma-

Razgrad AD, 68

Aprilsko Vastanie

Blvd, 7200 Razgrad,

Bulgaria

4256 Troypofol propofolemulsion for

injection/infusion

10mg/ml,

20ml glass vial

Troikaa


C-1, Sara Industrial

Estate, Selaqui,

Dehradun-248197,

Uttarakhand

India N01AX10 1640410.02.2017

10.02.2022PoM

Troikaa


Commerce House-1,

Satya Marg,

Bodakdev,

Ahmedabad-380054,

India

4257 Trozamil

azithromycin

(azithromycin

dihydrate)


in blister (3)

Special Product s Line

S.p.A., Via

Campobello, 15,

00040 Pomezia

(Rome)

Italy J01FA10 1267204.07.2013

04.07.2018PoM

So.Se. Pharm S.r.l.,

Via dei Castelli

Romani 22, 00040

Pomezia (Rome),

Italy

4258 Truvada

tenofovir (tenofovir

disoproxil

fumarate),

emtricitabine



Gilead Sciences

Ireland UC, IDA

Business and

Technology Park,

Carrigtohill, Co. Cork -

packager, batch

releaser (Takeda

GmbH Betriebsstatte

Oranienburg,

Lehnitzstrasse 70-98

16515 Oranienburg,

Germany

Ireland J05AR03 13986/111.01.2016

26.11.2019PoM

Gilead Sciences Inc.,

333 Lakeside Drive,

Foster City, CA

94404, USA

941

4259 Truvada

tenofovir (tenofovir

disoproxil

fumarate),

emtricitabine



Gilead Sciences

Ireland UC, IDA

Business and

Technology Park,


batch releaser (Takeda

GmbH Betriebsstatte

Oranienburg,


16515

Oranienburg,German

y - bulk

manufacturer)

(Catalent Germany

Schorndorf GmbH,



Germany - packager)

Ireland J05AR03 13987/111.01.2016

26.11.2019PoM


333 Lakeside Drive,

Foster City, CA

94404, USA

4260 Trypsin crystalline trypsin

powder lyophilized

for solution for

injection and for

topical use

10mg,

glass vial (10)

"Samson-Med" LLC,

Moscow highway, 13,

Saint Petersburg,

196158

Russia B06AA07 15739/115.09.2016

23.06.2021PoM

"Samson-Med" LLC,

Moscow highway, 13,

Saint Petersburg,

196158, Russia

4261Tularemia vaccine

live

tularemia vaccine

strain F.tularensis

15NIIEG live

microbial cells

powder lyophilized

for suspension for

cutaneous

scarification and

intracutaneous

injection

(2+0.5)x10^8 (cutaneous

scarification),

(1+0.1)x10^7

(intracutaneous use),

(5/1 ampoule(15-

50doses)+1 ampoule with

5ml solvent/)

FSUC "SIC Microgen"

MOH RF, 7, av. Mira,

Omsk region, Omsk,

644080

RussiaJ07A;

vaccine16478

06.03.2017

06.03.2022PoM

FSUC "SIC Microgen"

MOH RF, 15, 1-st

Dubrovskaya str.,

Moscow, 115088,

Russia

4262 Tulip

atorvastatin

(atorvastatin

calcium)

tablets film-coated

40mg,


60/6x10/, 90/9x10/)

Lek Pharmaceuticals


57, 1526 Ljubljana

Slovenia C10AA05 1668631.05.2017

31.05.2022PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

942

4263 Tulip

atorvastatin

(atorvastatin

calcium)

tablets film-coated

10mg,


60/6x10/, 90/9x10/)

Lek Pharmaceuticals


57, 1526 Ljubljana

Slovenia C10AA05 1668731.05.2017

31.05.2022PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

4264 Tulip

atorvastatin

(atorvastatin

calcium)

tablets film-coated

20mg,


60/6x10/, 90/9x10/)

Lek Pharmaceuticals


57, 1526 Ljubljana

Slovenia C10AA05 1668831.05.2017

31.05.2022PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

4265 Tulosin

tamsulosin

(tamsulosin

hydrochloride)

capsules modified-

release

0,4mg,



PLC, 9900, Kormend,


Hungary G04CA02 12712/123.07.2015

23.07.2018PoM


PLC, 1106 Budapest,


Hungary

4266 Tylocolinum-AFtylosin, colistin

(colistin sulfate)

solution for i/m

injection

50mg/ml+ 1000000U/ml,


vial

Scientific &

Production Enterprise

Agrofarm Co. Ltd.,

prospect Truda 10,

apt. 18, Voronezh,

394061

Russia

QJ01RA91;

veterinary

drug

15502/111.07.2016

19.04.2021PoM

Scientific &

Production

Enterprise Agrofarm

Co. Ltd., prospect

Truda 10, apt. 18,

Voronezh, 394061,

Russia

4267 Tylofan 20 tylosin solution for injection200mg/ml,

50ml glass vial

Erfan Darou

Pharmaceutical

Company, 19th street,

Second phase,

Hashtgerd industrial

city, Tehran

Iran

QJ01FA90;

veterinary

drug

14261/107.12.2015

20.02.2020PoM

Erfan Darou

Pharmaceutical

Company 19th street,

Second phase,

Hashtgerd industrial

city, Tehran, Iran

943

4268 Tyrez

bisoprolol

(bisoprolol

fumarate)

tablets film-coated2,5mg,



Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia)

Slovenia C07AB07 1242229.04.2013

29.04.2018PoM


Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

4269 Tyrez

bisoprolol

(bisoprolol

fumarate)




Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia)

Slovenia C07AB07 1242329.04.2013

29.04.2018PoM


Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

4270 Tyrez

bisoprolol

(bisoprolol

fumarate)




Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar


Skopje, Macedonia)

Slovenia C07AB07 1242429.04.2013

29.04.2018PoM


Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

944

4271 Tyrez

bisoprolol

(bisoprolol

fumarate)



Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C07AB07 1716330.11.2017

30.11.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

4272 Tyrez

bisoprolol

(bisoprolol

fumarate)



Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C07AB07 1716430.11.2017

30.11.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

4273 Tyrez

bisoprolol

(bisoprolol

fumarate)

tablets film-coated2,5mg,


Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C07AB07 1716530.11.2017

30.11.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

4274 Tyrosur tyrothricin gel for topical use1mg/g,

5g aluminium tube

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden

Germany D06AX08 1604617.10.2016

17.10.2021OTC

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden,

Germany

4275 Tyrosur tyrothricinpowder for topical

use

1mg/g,

5g and 20g in plastic vial

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden

Germany D06AX08 1665011.05.2017

11.05.2022OTC

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden,

Germany

945

4276 Tyverb

lapatinib (lapatinib

ditosylate

monohydrate)


plastic bottle (70)


Avenida de

Extremadura, 3,

09400 Aranda de

Duero, Burgos -

packager, batch


manufacturer - Glaxo

Wellcome

Operations, Priory

Street, Ware,

Hertfordshire, SG12

0DJ, UK)

Spain L01XE07 12783/127.07.2016

14.08.2018PoM

Novartis Pharma AG,


Basel, Switzerland

4277 Tyverb

lapatinib (lapatinib

ditosylate

monohydrate)


in plastic bottle (70)



09400 Aranda de

Duero, Burgos-batch

releaser, packager,

Glaxo Wellcome

Operations, Priory

Street, Ware,

Hertfordshire, SG12

0DJ, UK- bulk

manufacturer

Spain L01XE07 1720008.12.2017

08.12.2022PoM

Novartis Pharma AG,


Basel, Switzerland

4278 Tyzine

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

0,5mg/ml,

10ml glass bottle (140

dose)

Famar Orleans, 5

avenue de Concyr,

45071 Orleans Cedex

02

France R01AA07 1312810.01.2014

10.01.2019OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

4279 Tyzine

xylometazoline

(xylometazoline

hydrochloride)

spray nasal1mg/ml,

10ml glass bottle (70 dose)

Famar Orleans 5

avenue de Concyr,

45071 Orleans Cedex

2

France R01AA07 1312910.01.2014

10.01.2019OTC

Johnson & Johnson

LLC, Russia 121614,

Moscow, Krylatskaya


France

946

4280 Ubistesin


hydrochloride),

epinephrine

(epinephrine

hydrochloride)

solution for injection40mg/ml+ 0,006mg/ml,

1,7ml cartridges (50)

3M Deutschland

GmbH, ESPE Platz

82229 Seefeld

Germany N01BB58 1288125.09.2013

25.09.2018PoM

3M Deutschland

GmbH, Carl-Schurz

Strasse 1, 42453

Neuss, Germany

4281 Ubistesin forte


hydrochloride),

epinephrine

(epinephrine

hydrochloride)



3M Deutschland

GmbH, ESPE Platz

82229 Seefeld

Germany N01BB58 1288225.09.2013

25.09.2018PoM

3M Deutschland

GmbH, Carl-Schurz

Strasse 1, 42453

Neuss, Germany

4282 Ulcavis

bismuth

tripotassium

dicitrate (bismuth

oxide)

tablets film-coated

120mg,


56/4x14/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A02BX05 1665711.05.2017

11.05.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4283 Ultibro Breezhaler

indacaterol

(indacaterol

maleate),

glycopyrronium

(glycopyrronium

bromide)

inhalation powder,

hard capsules

110mcg+50mcg,

in blister and inhaler

(30/5x6/)

Novartis Pharma

Stein AG,


4332 Stein

Switzerland R03AL04 1398026.11.2014

26.11.2019PoM

Novartis Pharma AG,


Basel, Switzerland

4284 Ultracain D-S forte


hydrochloride),

epinephrine

(epinephrine

hydrochloride)


40mg/ml+ 0,012mg/ml,

1,7ml cartridges

(100/10x10/)

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,



Main

Germany N01BB58 1417216.01.2015

16.01.2020PoM

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,



Main, Germany

4285 Ultraproct

fluocortolone

pivalate,

fluocortolone

hexanoate,

cinchocaine

(cinchocaine

hydrochloride)

ointment rectal

0.918mg/g+

0,945mg/g+5mg/g, 30g

aluminium tube

Bayer Healthcare


Via E. Schering 21,

20090 Segrate

(Milano)

Italy C05AX03 1635030.12.2016

30.12.2021OTC

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

947

4286 Ultraproct

fluocortolone

pivalate,

fluocortolone

hexanoate,

cinchocaine

(cinchocaine

hydrochloride)

suppositories rectal0,612mg+0,63mg+1mg,

(10/2x5/)

Bayer Healthcare


Via E. Schering 21,

20090 Segrate

(Milano)

Italy C05AX03 1635130.12.2016

30.12.2021OTC

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

4287 Ultravist 370 iopromide solution for injection

769mg/ml

(370mg iodine/ml), 50ml,


Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin

Germany V08AB05 1705105.10.2017

05.10.2022PoM

Bayer Vital GmbH,

51368 Leverkusen,

Germany

4288 Umckalorpelargonium

sidoidestablets film-coated

20mg,


30/2x15/)

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Str. 4, 76227

Karlsruhe

GermanyR05CA;

herbal drug15566

12.05.2016

12.05.2021OTC

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Str. 4, 76227

Karlsruhe, Germany

4289 Umckalorpelargonium

sidoidessolution oral

800mg/g,

20ml, 50ml glass vial-

dropper

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Strasse 4, 76227

Karlsruhe

GermanyR05CA;

herbal drug16065

17.10.2016

17.10.2021OTC

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Strasse 4, 76227

Karlsruhe, Germany

4290 Unidox Solutab

doxycycline

(doxycycline

monohydrate)

tablets dispersible100mg,


Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel,

the Netherlands J01AA02 1599815.09.2016

15.09.2021PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

948

4291Unienzyme cMPS

tablets

fungal diastase

(1:800),

simethicone, papain

(6000U/mg),

activated charcoal,

nicotinamide

tablets coated

20mg+50mg+

30mg+75mg+ 25mg, in

strip (20/2x10/)

Unichem Laboratories

Ltd., C-31 & 32,

Industrial Area,

Meerut Road,

Ghaziabad 201 003

(U.P.)

India A09AA02 1474803.08.2015

03.08.2020OTC

Ginanto Limited,15

Them. Dervis Street,

Margarita House, P.C.

1066, Nicosia, Cyprus

4292 Unigamma

benfotiamine,

pyridoxine

(pyridoxine

hydrochloride),

cyanocobalamin

tablets film-coated100mg+100mg+ 200mcg,


Unipharm Inc., 75

Progress Lane,

Waterbury,

Connecticut (CT),

06705

USA A11DB 1509815.12.2015

15.12.2020PoM

Unipharm Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

4293 Unithiol 50mg/ml

dimercaprol

(dimercaptopropans

ulfonat sodium)


s/c injection

50mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Ajaryan street,

2 Line, No 6

Republic of

ArmeniaV03AB09 14570

09.06.2015

09.06.2020PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Ajaryan street,

2 Line, No 6,

Republic of Armenia

4294 Uperio 24mg/26mgsacubitril, valsartan

(valsartan sodium)tablets film-coated

24,3mg+25,7mg,




131, 80058 Torre

Annunziata, (NA)

Italy C09DX04 1632330.12.2016

30.12.2021PoM

Novartis Pharma

Services AG,


Basel, Switzerland

949



24,3mg+25,7mg, in

blister (28/2x14/)



131, 80058 Torre

Annunziata, (NA) -

packager, batch

releaser, Novartis

Singapore

Pharmaceutical

Manufacturing Pte.

Ltd., 10 Tuas Bay

Lane, 637461

Singapore, Singapore-

bulk manufacturer

Italy C09DX04 1632430.12.2016

30.12.2021PoM

Novartis Pharma

Services AG,


Basel, Switzerland



24,3mg+25,7mg, in

blister (28/2x14/)



131, 80058 Torre

Annunziata, (NA) -

packager, batch

releaser, Novartis

Pharma Stein AG,


4332 Stein,

Switzerland - bulk

manufaturer

Italy C09DX04 1632730.12.2016

30.12.2021PoM

Novartis Pharma

Services AG,


Basel, Switzerland



48.6mg+51,4mg, in

blister (28/2x14/)



131, 80058 Torre

Annunziata, (NA)

Italy C09DX04 1632230.12.2016

30.12.2021PoM

Novartis Pharma

Services AG,


Basel, Switzerland

950



48.6mg+51,4mg, in

blister (28/2x14/)



131, 80058 Torre

Annunziata, (NA) -

packager, batch

releaser, Novartis

Singapore

Pharmaceutical

Manufacturing Pte.

Ltd., 10 Tuas Bay

Lane, 637461


bulk manufacturer

Italy C09DX04 1632530.12.2016

30.12.2021PoM

Novartis Pharma

Services AG,


Basel, Switzerland



48.6mg+51.4mg,




131, 80058 Torre

Annunziata, (NA) -

packager, batch

releaser, Novartis

Pharma Stein AG,


4332 Stein,

Switzerland - bulk

manufaturer

Italy C09DX04 1632930.12.2016

30.12.2021PoM

Novartis Pharma

Services AG,


Basel, Switzerland

4300Uperio

97mg/103mg

sacubitril, valsartan


97.2mg+102.8mg, in

blister (28/2x14/)



131, 80058 Torre

Annunziata, (NA)

Italy C09DX04 1632130.12.2016

30.12.2021PoM

Novartis Pharma

Services AG,


Basel, Switzerland

951

4301Uperio

97mg/103mg



97.2mg+102.8mg, in

blister (28/2x14/)



131, 80058 Torre

Annunziata, (NA) -

packager, batch

releaser, Novartis

Singapore

Pharmaceutical

Manufacturing Pte.

Ltd., 10 Tuas Bay

Lane, 637461


bulk manufacturer

Italy C09DX04 1632630.12.2016

30.12.2021PoM

Novartis Pharma

Services AG,


Basel, Switzerland

4302Uperio

97mg/103mg



97.2mg+102.8mg, in

blister (28/2x14/)



131, 80058 Torre

Annunziata, (NA) -

packager, batch

releaser, Novartis

Pharma Stein AG,


4332 Stein,

Switzerland - bulk

manufaturer

Italy C09DX04 1632830.12.2016

30.12.2021PoM

Novartis Pharma

Services AG,


Basel, Switzerland

4303 Upsarin Upsa acetylsalicylic acid tablets effervescent500mg,

in strip (16/4x4/)

UPSA SAS, 979,

Avenue des Pyrenees,

47520 Le Passage

France N02BA01 1699405.09.2017

05.09.2022OTC

UPSA SAS, 3, rue

Joseph Monier- 92500

Rueil- Malmaison,

France

952

4304Upsarin Upsa with

vitamin C

acetylsalicylic acid,

ascorbic acidtablets effervescent

330mg+200mg,


Bristol-Myers Squibb,

979, Avenue des

Pyrenees, 47520 Le

Passage

France N02BA51 1491202.10.2015

02.10.2020OTC

Bristol-Myers Squibb,

3, rue Joseph Monier,

BP 325, 92506 Rueil-

Malmaison Cedex,

France

4305 Urdoxaursodeoxycholic

acidcapsules

250mg,


20/2x10/, 30/3x10/,

40/4x10/, 50/5x10/,

60/6x10/, 70/7x10/,

80/8x10/, 90/9x10/,

100/10x10/),


100)

Pharmproject JSC,

bld. 14, lit. A,

Sofiyskaya str., Saint

Petersburg, 192236

Russia A05AA02 1630630.12.2016

30.12.2021PoM

Obolenskoye PhC

JSC, bld. 7-8,

Obolensk, Serpukhov

district, Moscow

region, 142279,

Russia

4306 Urocit-K potassium citrate tablets modified-

release

1080mg,


Mission Pharmacal

Company, 38505 IH

10 West, Boerne,

Texas (TX) 78006

USA G04BC 1690208.08.2017

08.08.2022PoM

Mission Pharmacal

Company, San

Antonio, TX, 78230

1355, USA

4307 Uroflox

rufloxacin

(rufloxacin

hydrochloride)



Mediolanum

Farmaceutici S.P.A.,

Via San Giuseppe

Cottolengo, 15-20143

Milan(MI)-batch

releaser, Doppel

Farmaceutici S.R.L.,

Via Volturno, 48-

Quinto De Stampi-

20089 Rozzano Milan,

Italy-bulk

manufacturer,

packager

Italy J01MA10 1424920.02.2015

20.02.2020PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

953

4308 Urolesan

abies oil, mentha

piperita oil, daucus

carota fluid extract,

humulus lupulus

fluid extract,

origanum fluid

extract

drops oral

67,6mg/ml+ 16,9mg/ml+

194,35mg/ml+

278,8mg/ml+

192,95mg/ml,

25ml bottle-dropper

Halychpharm JSC,


Oprishkovskaya, 6/8

UkraineG04BX;

herbal drug17231

08.12.2017

08.12.2022OTC

Halychpharm JSC,



Ukraine

4309 Urorec silodosin capsules hard

4mg,

in blister

(10, 30/3x10/)

Recordati Industria

Chimica e

Farmaceutica S.p.A.

Via M Civitali 1-

20148 Milan

Italy G04CA04 1275114.08.2013

14.08.2018PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

4310 Urorec silodosin capsules hard

8mg,

in blister

(10, 30/3x10/)

Recordati Industria

Chimica e

Farmaceutica S.p.A.

Via M Civitali 1-

20148 Milan

Italy G04CA04 1275214.08.2013

14.08.2018PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

4311 Urotractin

pipemidic acid

(pipemidic acid

trihydrate)

capsules400mg,


Polipharm Co., Ltd.,

109 Bangna-Trad

Road, Bang Phli

District, Samut

Prakan 10540

Thailand J01MB04 1579920.07.2016

20.07.2021PoM

Eurodrug

Laboratories S.A.,

Kortrijksesteenweg

214, 9830 Sint-

Martens-Latem,

Belgium

4312 Uro-Vaxom

lyophilized

bacterial lysates of

Escherichia coli

capsules6mg,


OM Pharma SA, 22,

rue du Bois-du-Lan,

1217 Meyrin 2

Switzerland L03AX 1574023.06.2016

23.06.2021PoM

OM Pharma SA, 22,

rue du Bois-du-Lan,

1217 Meyrin 2,

Switzerland

4313 Ursocamursodeoxycholic

acidtablets

250mg,


100), in blister (25/1x25/,

100/4x25/)

Polfarmex S.A.,

Jozefow 9 Street, 99-

300 Kutno

Poland A05AA02 1222707.03.2013

07.03.2018PoM

Polfarmex S.A.,

Jozefow 9 Street, 99-

300 Kutno, POLAND

954

4314 Ursoromursodeoxycholic

acidcapsules

250mg,


S.C. Rompharm

Company S.R.L.

(Ilfov, 75100 Otopeni,

Str. Eroilor, Nr. 1A)

Romania A05AA02 1288607.10.2013

07.10.2018PoM

S.C. Rompharm

Company S.R.L.

(Ilfov, 75100 Otopeni,

Str. Eroilor, Nr. 1A,

Romania)

4315 Ursosanursodeoxycholic

acidcapsules

250mg,


PRO.MED.CS Praha

a.s.,Telcska 1, Praha 4,

140 00

Czech Republic A05AA02 1249528.08.2014

28.08.2019PoM

PRO.MED.CS Praha

a.s.,Telcska 1, Praha

4, 140 00, Czech

Republic

4316 Utrogestan progesteronecapsules soft oral or

vaginal

200mg,


OLIC (Thailand)

Limited 166 Moo 16,

Bangpa-In Industrial

Estate, Udomsorayuth

Road, Bangkrason,

Ayutthaya Province

13160

Thailand G03DA04 1333417.03.2014

17.03.2019PoM

Besins Healthcare SA,

Avenue Louise 287,

1050 Brussels,

Belgium

4317 Utrogestan progesteronecapsules soft oral or

vaginal

100mg,


OLIC (Thailand)

Limited 166 Moo 16,

Bangpa-In Industrial

Estate, Udomsorayuth

Road, Bangkrason,

Ayutthaya Province

13160

Thailand G03DA04 1333517.03.2014

17.03.2019PoM


Avenue Louise 287,

1050 Brussels,

Belgium

4318 Utrogestan progesterone capsules soft200mg,


Cyndea Pharma SL,

Poligono Industrial

Emiliano Revilla Sanz,

Avenida de Agreda,

31, Olvega

42110(Soria)

Spain G03DA04 1615923.11.2016

23.11.2021PoM


Avenue Louise 287,

1050 Brussels,

Belgium

955

4319 Utrogestan progesterone capsules soft100mg,


Cyndea Pharma SL,

Poligono Industrial

Emiliano Revilla Sanz,

Avenida de Agreda,

31, Olvega

42110(Soria)

Spain G03DA04 1616023.11.2016

23.11.2021PoM


Avenue Louise 287,

1050 Brussels,

Belgium

4320 Utrogestan 200mg progesterone capsules200mg,


Besins Manufacturing

Belgium, Groot

Bijgaardenstraat 128,

Drogenbos, B-1620 -

packager, batch


manufacturer -

Capsugel Ploermel,

Z.I. de Camagnon,

56800 Ploermel,

France)

Belgium G03DA04 1250901.06.2013

01.06.2018PoM


Avenue Louise 287,

1050 Brussels,

Belgium

4321 Uvenasildenafil (sildenafil

citrate)capsules

50mg,

in blister

(1,4/1x4/, 8/2x4/)

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,


222120, Minsk oblast)

Belarus G04BE03 1298028.10.2013

28.10.2018PoM

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus)

4322 Uvenasildenafil (sildenafil

citrate)capsules

100mg,

in blister

(1,4/1x4/, 8/2x4/)

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,


222120, Minsk oblast)

Belarus G04BE03 1298128.10.2013

28.10.2018PoM

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus)

956

4323 Vaginorm-C ascorbic acid tablets vaginal250mg

(6)

Artesan Pharma

GmbH & Co. KG,

Wendlandstrasse, 1-

29439 Luchow

Germany G01AD03 1300813.11.2013

13.11.2018OTC

Polichem S.A., 50,

Val Fleuri, L-1526,

Luxembourg,

Luxembourg

4324 Valaciclovir

valaciclovir

(valaciclovir

hydrochloride)



Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ05AB11 14330

25.03.2015

25.03.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

4325

Valaciclovir/Pharm

athen International

500mg film-coated

tablets

valaciclovir

(valaciclovir

hydrochloride)



Pharmathen S.A.,


Pallini, Attiki

Greece J05AB11 1527104.02.2016

04.02.2021PoM

Pharmathen S.A.,



4326 Valcyte

valganciclovir

(valganciclovir

hydrochloride)



F. Hoffmann-La

Roche Ltd,

Wurmisweg, CH-

4303 Kaiseraugust-

batch releaser,

secondary packager,

Patheon Inc., 2100

Syntex Court,

Mississauga, Ontario,

L5N 7K9, Canada-

bulk manufacturer,

primary packager

Switzerland J05AB14 1427819.03.2015

19.03.2020PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124 Basel, CH-4070,

Switzerland

957

4327 Valerian extractvalerian thick


20mg,


(50) in plastic container

Pharmstandard-

Tomskchimpharm


R.Luxemburg str. 89-

batch releaser,

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211,

Russia-bulk

manufacturer,

packager

RussiaN05CM09;

herbal drug 14655

03.07.2015

03.07.2020OTC

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211,

Russia

4328 Valerian extractvalerian thick

extracttablets coated

20mg,


50/2x25/), in glass

container (50), in blisters

(500/10/), in blisters

(300/25/), glass container

(110/50/)

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


BelarusN05CM09;

herbal drug16563

03.04.2017

03.04.2022OTC

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

4329 Valeriana valeriane tincture tincture200mg/ml; glass vial-

dropper 25ml

'Lubnypharm' PJSC,


Lubny, Petrovskogo

str. 16

UkraineN05CM09;

herbal drug15413

09.03.2016

09.03.2021OTC

Lubnypharm' PJSC,


Lubny, Petrovskogo

str. 16, Ukraine

4330 Valeriana fortevalerian thick

extracttablets

150mg,


Open joint stock


zavod medicinskikh

preparatov" 64/27,



BelarusN05CM09;

herbal drug 14445

04.05.2015

04.05.2020OTC

Open joint stock


zavod medicinskikh

preparatov" 64/27,


222120, Minsk

region, Belarus

958

4331 Valerianae tincture valerianae extract tincture200mg/ml,

30ml glass vial

Open joint stock


zavod medicinskikh

preparatov" 64,



BelarusN05CM09;

herbal drug15530

19.04.2016

19.04.2021OTC

Open joint stock


zavod medicinskikh

preparatov" 64,



4332 Valerian-Belmed

valerianae rhizomes

with roots (as

powder)

tablets coated

200mg,


20/2x10/, 30/3x10/,

50/5x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

BelarusN05CM09;

herbal drug 15792

20.07.2016

20.07.2021OTC

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

4333 Validolmenthol solution in

menthyl isovaleratecapsules sublingual

100mg,


Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus C01EX 1358510.06.2014

10.06.2019OTC

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

4334 Validol

levomenthol

solution in menthyl

isovalerate

tablets sublingual

60mg,


10/1x10/)

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-


RussiaC01EX;

herbal drug14228

20.02.2015

20.02.2020OTC

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

4335 Validolmenthol solution in

menthyl isovaleratecapsules

100mg,


Minskintercaps U.V.,

26/3, Inzhenernaya

str., 220075, Minsk

Belarus C01EX 1714807.11.2017

07.11.2022OTC


26, Inzhenernaya str.,

220075, Minsk,

Belarus

4336Validol with

glucose

levomenthol

solution in menthyl

isovalerate, dextrose

(dextrose

monohydrate)

tablets sublingual60mg+188mg,

in blister (10)

Irbitskiy

himfarmzavod OJSC,

124-a, K. Marksa str.,

Irbit, St. Sverdlovsk,

623856

Russia C01EX 1638510.02.2017

10.02.2022OTC

Irbitskiy

himfarmzavod OJSC,

172, Kirova str., Irbit,

St. Sverdlovsk,

623856, Russia

959

4337 Validol-Darnitsamenthol solution in

menthyl isovaleratetablets sublingual

60mg,

in blister (6, 10)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine C01EX 1249701.06.2013

01.06.2018OTC

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

4338Validol-

Pharmstandard

levomenthol

solution in methyl

isovaleriate

tablets sublingual60mg,

in blister (10)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia C01EX 1676031.05.2017

31.05.2022OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

4339 Valium diazepam tablets5mg,


Roche Farma S.A,

C/Severo Ochoa, 13

Poligono Industrial de

Leganes Madrid

Spain N05BA01 1390409.10.2014

09.10.2019PoM/UC

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

4340 Valmox

levofloxacin

(levofloxacin

hemihydrate)




Chirnakhuli Str. 14,

0198 Tbilisi-batch

releaser, packager,

M/s INNOVA

CAPTAB, 81-B, EPIP,

Phase-I, Jharmajri,

Baddi, Distt. Solan

[H.P.], India-bulk

manufacturer

Georgia J01MA12 1600406.10.2016

06.10.2021PoM


Chirnakhuli Str. 14,


4341 Valocordinethylbromisovale-

rate, phenobarbital, drops oral (solution)

18,4mg/ml+ 18,4mg/ml,

20ml and 50ml glass

bottle

Krewel Meuselbach

GmbH, Xavier-

Vorbruggen str. 6,

98708 Gehren

Germany N05CB02 1677622.06.2017

22.06.2022OTC

Krewel Meuselbach


53783 Eitorf,

Germany

960

4342 Valsacor valsartan tablets film-coated80mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09CA03 1491620.10.2015

20.10.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4343 Valsacor valsartan tablets film-coated160mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09CA03 1491720.10.2015

20.10.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4344 Valsacor H 160

valsartan,

hydrochloro-

thiazide



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09DA03 1566908.06.2016

08.06.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4345 Valsacor H 80

valsartan,

hydrochloro-

thiazide



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09DA03 1566708.06.2016

08.06.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4346 Valsacor HD 160

valsartan,

hydrochloro-

thiazide

tablets film-coated

160mg+25mg,


28/2x14/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09DA03 1566808.06.2016

08.06.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4347 Valsar-Denk 160 valsartan tablets film-coated160mg,


Denk Pharma GmbH


84529 Tittmoning

Germany C09CA03 1489024.09.2015

24.09.2020PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

4348 Valsar-Denk 320 valsartan tablets film-coated 320mg

Denk Pharma GmbH


84529 Tittmoning

Germany C09CA03 1492520.10.2015

20.10.2020PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

961



Denk Pharma GmbH


84529 Tittmoning

Germany C09CA03 1550519.04.2016

19.04.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany



Denk Pharma GmbH


84529 Tittmoning

Germany C09CA03 1492420.10.2015

20.10.2020PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

4351 Valtrexvalaciclovir(valacicl

ovir hydrochloride)tablets film-coated

500mg,

in blister (10)

GlaxoSmithKline

Pharmaceuticals SA,

189 Grunwaldzka str.

60-322 Poznan -


form manufacturer -

Glaxowelcome S.A.,

09400 Aranda de

Duero, Burgos, Spain)

Poland J05AB11 1267712.07.2013

12.07.2018PoM

GlaxoSmithKline

S.A., Severo Ochoa, 2

28760-Tres Cantos

(Madrid), Spain

4352 Valusal ketoprofen gel for external use

25mg/g,

30g and 50g aluminium

tube

Grindeks JSC,


1057, Riga

Latvia M02AA10 1393729.10.2014

29.10.2019PoM

Grindeks JSC,



4353 Valused

valerian root dry

extract, hop

strobiles dry

extract, passion

flower dry extract

capsules soft60mg+40mg+ 40mg,


P.P.F. "Hasco-Lek"

S.A., ul. Zmigrodzka

242 E, 51-131

Wroclaw

PolandN05CM;

herbal drug17093

23.10.2017

23.10.2022OTC

P.P.F. "Hasco-Lek"

S.A., ul. Zmigrodzka

242 E, 51-131

Wroclaw, Poland

962

4354 Valz valsartan tablets film-coated

40mg,


30/3x10/, 56/4x14/,

90/9x10/, 98/7x14/,

100/10x10/)

Balkanpharma-

Dupnitsa AD,

str."Samokovsko


2600

Bulgaria C09CA03 1653017.03.2017

17.03.2022PoM

"Actavis Group PTC

ehf",


78, IS-220

Hafnarfjordur,

Iceland


80mg,


30/3x10/, 56/4x14/,

90/9x10/, 98/7x14/,

100/10x10/)

Balkanpharma-

Dupnitsa AD,

str."Samokovsko


2600

Bulgaria C09CA03 1653117.03.2017

17.03.2022PoM

"Actavis Group PTC

ehf",


78, IS-220

Hafnarfjordur,

Iceland


160mg,


30/3x10/, 56/4x14/,

90/9x10/, 98/7x14/,

100/10x10/)

Balkanpharma-

Dupnitsa AD,

str."Samokovsko


2600

Bulgaria C09CA03 1653217.03.2017

17.03.2022PoM

"Actavis Group PTC

ehf",


78, IS-220

Hafnarfjordur,

Iceland

4357 Valz H

valsartan,

hydrochlorothiazid

e

tablets film-coated

160mg+12,5mg,


30/3x10/, 56/4x14/,

90/9x10/, 98/7x14/,

100/10x10/)

Balkanpharma-

Dupnitsa AD,

str."Samokovsko


2600

Bulgaria C09DA03 1653317.03.2017

17.03.2022PoM

"Actavis Group PTC

ehf",


78, IS-220

Hafnarfjordur,

Iceland

4358 Valz H

valsartan,

hydrochlorothiazid

e

tablets film-coated

80mg+12,5mg,


30/3x10/, 56/4x14/,

90/9x10/, 98/7x14/)

Balkanpharma-

Dupnitsa AD,

str."Samokovsko


2600

Bulgaria C09DA03 1653417.03.2017

17.03.2022PoM

"Actavis Group PTC

ehf",


78, IS-220

Hafnarfjordur,

Iceland

963

4359 Vametal

ondansetron

(ondansetron

hydrochloride

dihydrate)


i/m injection

2mg/ml,

4ml glass vial

Help S.A., Pedini


45500

Greece A04AA01 14112/102.02.2017

29.12.2019PoM

Medicus S.A., 10

Valaoritou str., GR

144 52,

Metamorphosis,

Attika, Greece

4360 Vametal

ondansetron

(ondansetron

hydrochloride

dihydrate)


blisters (15/3x5/)

Help S.A., Pedini


45500

Greece A04AA01 14113/102.02.2017

29.12.2019PoM

Medicus S.A., 10

Valaoritou str., GR

144 52,

Metamorphosis,

Attika, Greece

4361 Vametal

ondansetron

(ondansetron

hydrochloride

dihydrate)


i/m injection

2mg/ml,

2ml glass vial

Help S.A., Pedini


45500

Greece A04AA01 14114/102.02.2017

29.12.2019PoM

Medicus S.A., 10

Valaoritou str., GR

144 52,

Metamorphosis,

Attika, Greece

4362 Vamloset

amlodipine

(amlodipine

besilate), valsartan



Krka-RUS LLC 50

Moskovskaya str.,

Istra, Moscow region

143500

Russia C09DB01 1580820.07.2016

20.07.2021PoM

Krka-RUS LLC 50

Moskovskaya str.,


143500, Russia

4363 Vamloset

amlodipine

(amlodipine




Krka-RUS LLC 50

Moskovskaya str.,


143500

Russia C09DB01 1580920.07.2016

20.07.2021PoM

Krka-RUS LLC 50

Moskovskaya str.,


143500, Russia

4364 Vamloset

amlodipine

(amlodipine




Krka-RUS LLC 50

Moskovskaya str.,


143500

Russia C09DB01 1581020.07.2016

20.07.2021PoM

Krka-RUS LLC 50

Moskovskaya str.,


143500, Russia

964

4365Vancomycin

enterocaps 250mg

vancomycin

(vancomycin

hydrochloride)

capsules hard250mg,


Riemser Pharma

GmbH, An der Wiek

7 17493 Greifswald-

Insel Riems-batch

releaser (bulk

manufacturer-MW

Encap Limited,

Building 1, Units 4 5

&6 Oakbank Park

Way Mid Calder

Livingston West

Lothian EH53 0TH,

UK) (packager-L-A-

W Services GmbH-

Leipziger

Arzneimittelwerk,

Elisabeth-

Schumacher-Strasse

54/56 04328 Leipzig,

Germany)

Germany A07AA09 1579520.07.2016

20.07.2021PoM

Riemser Pharma

GmbH, An der Wiek

7 17493 Greifswald-

Insel Riems,

Germany

4366Vancomycin-

TEVA

vancomycin

(vancomycin

hydrochloride)

powder lyophilized

for solution for

injection

500mg,

glass vial (1)

Teva Pharmaceutical

Works Private

Limited Company, H-

2100 Godollo,


Hungary J01XA01 1392329.10.2014

29.10.2019PoM

Teva Pharmaceutical

Industries Ltd., 5


3190, Petach Tikva,

49131, Israel

4367Vancomycin-

TEVA

vancomycin

(vancomycin

hydrochloride)

powder lyophilized

for solution for

injection

1000mg,

glass vial (1)

Teva Pharmaceutical

Works Private

Limited Company, H-

2100 Godollo,


Hungary J01XA01 1392429.10.2014

29.10.2019PoM

Teva Pharmaceutical

Industries Ltd., 5


3190, Petach Tikva,

49131, Israel

4368 Vardmox-500

amoxicillin

(amoxicillin

trihydrate)

capsules500mg,


Vardhman Exports, A-

188, T.T.C., MIDC

Industrial Area,

Khairane, Navi

Mumbai- 400 710

India J01CA04 1328604.03.2014

04.03.2019PoM

Vardhman Exports,

Ghatkopar (W),

Mumbai-400086,

India

965

4369 Vasaprostan alprostadil

powder lyophilized

for solution for

infusion

20mcg,

5ml ampoules (10)

Aesica

Pharmaceuticals

GmbH, Alfred-Nobel-

Str. 10, 40789

Monheim - batch


manufacturer - Bayer

Pharma AG, Kaiser-

Wilhelm-Allee, 51368

Leverkusen,

Germany)

Germany C01EA01 1216801.02.2013

01.02.2018PoM

UCB Pharma

GmbH,Alfred-Nobel-

Str. 10, 40789

Monheim, Germany

4370 Vasilip simvastatin tablets film-coated40mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA01 1553919.04.2016

19.04.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA01 1694705.09.2017

05.09.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA01 1694805.09.2017

05.09.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4373Vasonit retard

600mgpentoxifylline

tablets prolonged-

release film-coated

600mg,


G.L. Pharma GmbH,

Schlossplatz 1, 8502

Lannach -batch

releaser, G.L. Pharma

GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria C04AD03 1439916.04.2015

16.04.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

966

4374 Vazonat

meldonium

(meldonium

dihydrate)

solution for i/v

injection

100mg/ml,

5ml ampoules (10)

Olainfarm JSC, 5


LV-2114-batch

releaser, Sopharma

JSC, str. Iliensko

shosse 16, 1220 Sofia,

Bulgaria- bulk

manufacturer,

packager

Latvia C01EB22 1681810.07.2017

10.07.2022PoM

Olainfarm JSC, 5


LV-2114, Latvia

4375 Vazonat

meldonium

(meldonium

dihydrate)

capsules

250mg,


40/4x10/, 60/6x10)

Olainfarm JSC, 5


LV-2114

Latvia C01EB22 1702926.09.2017

26.09.2022PoM

Olainfarm JSC, 5


LV-2114, Latvia

4376 Vectra 3D

dinotefuran,

pyriproxyfen,

permethrin

solution spot-on

54mg/ml+ 4.84mg/ml+

397mg/ml, (3) tube with

applicator 0.8ml, 1.6ml,

3.6ml, 4.7ml, 8ml

Ceva Sante Animale,

10 av. de la

Ballastiere, 33500

Libourne- batch

releaser, EI A

pharmaceutical

solutionworks, 2865

North. Canon BLVD,

28083 Kannapolis,

North Carolina, USA-

bulk manufacturer,

packager

France

QP53AC54;

veterinary

drug

1622306.12.2016

06.12.2021PoM

Ceva Sante Animale,

10 av. de la

Ballastiere, 33500

Libourne, France

4377 Vegamax 100sildenafil (sildenafil

citrate)tablets

100mg,

in blister (4)

Perdaman

Pharmaceutical Pvt.

Ltd, 286,287-A,287-B

Sector-E Industrial

Area,Sanwer

Road,Indore(M.P.)

India G04BE03 12707/130.08.2013

23.07.2018PoM

Perdaman

Pharmaceutical Pvt.

Ltd,Level-11,A-

111,Himalaya House,

KG Marg,Connaught

Place,110001, India

967

4378 Vegamax 50sildenafil (sildenafil

citrate)tablets

50mg,

in blister (4)

Perdaman

Pharmaceutical Pvt.

Ltd, 286,287-A,287-B

Sector-E Industrial

Area,Sanwer

Road,Indore(M.P.)

India G04BE03 12706/130.08.2013

23.07.2018PoM

Perdaman

Pharmaceutical Pvt.

Ltd,Level-11,A-

111,Himalaya House,

KG Marg,Connaught

Place,110001, India

4379 Vegarpisildenafil (sildenafil

citrate)tablets coated

100mg,

in blister (4/1x4/,

10/1x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaG04BE03 15693

08.06.2016

08.06.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

4380 Vegarpisildenafil (sildenafil

citrate)tablets coated

50mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaG04BE03 16645

02.05.2017

02.05.2022PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

4381 Vegarra 100sildenafil (sildenafil


100mg,

in blister (4)

ALPHA_Aleppo

Pharmaceutical

Industries, Mansoura,

Aleppo

Syria G04BE03 1263725.06.2013

25.06.2018PoM

ALPHA-Aleppo

Pharmaceutical

Industries, Baron

Street, Aleppo, Syria

4382 Vegarra 50sildenafil (sildenafil


50mg,

in blister (4)

ALPHA_Aleppo

Pharmaceutical

Industries, Mansoura,

Aleppo

Syria G04BE03 1263625.06.2013

25.06.2018PoM

ALPHA-Aleppo

Pharmaceutical

Industries, Baron

Street, Aleppo, Syria

968

4383 Velaxin

venlafaxine

(venlafaxine

hydrochloride)

capsules prolonged-

release

37,5mg,



PLC, 1165 Budapest,



releaser (bulk

manufacturer - Egis


9900, Kormend,

Matyas kiraly st. 65,

Hungary)

Hungary N06AX16 12560/103.07.2015

06.06.2018PoM


PLC, 1106 Budapest,


Hungary

4384 Velaxin

venlafaxine

(venlafaxine

hydrochloride)

capsules prolonged-

release

75mg,



PLC, 1165 Budapest,



releaser (bulk

manufacturer - Egis


9900, Kormend,


Hungary)

Hungary N06AX16 12561/103.07.2015

06.06.2018PoM


PLC, 1106 Budapest,


Hungary

4385 Velaxin

venlafaxine

(venlafaxine

hydrochloride)

capsules prolonged-

release

150mg,



PLC, 1165 Budapest,



releaser (bulk

manufacturer - Egis


9900, Kormend,


Hungary)

Hungary N06AX16 12562/103.07.2015

06.06.2018PoM


PLC, 1106 Budapest,


Hungary

4386 Velaxin

venlafaxine

(venlafaxine

hydrochloride)

capsules prolonged-

release

150mg,



PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary N06AX16 1707305.10.2017

05.10.2022PoM


PLC, 1106 Budapest,


Hungary

969

4387 Velaxin

venlafaxine

(venlafaxine

hydrochloride)

capsules prolonged-

release

37,5mg,



PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary N06AX16 1707405.10.2017

05.10.2022PoM


PLC, 1106 Budapest,


Hungary

4388 Velaxin

venlafaxine

(venlafaxine

hydrochloride)

capsules prolonged-

release

75mg,



PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary N06AX16 1707505.10.2017

05.10.2022PoM


PLC, 1106 Budapest,


Hungary

4389 Venlaxor

venlafaxine

(venlafaxine

hydrochloride)

tablets75mg,


Grindeks JSC,


1057, Riga

Latvia N06AX16 1641010.02.2017

10.02.2022PoM

Grindeks JSC,



4390 Venlaxor

venlafaxine

(venlafaxine

hydrochloride)

tablets37,5mg,


Grindeks JSC,


1057, Riga

Latvia N06AX16 1641110.02.2017

10.02.2022PoM

Grindeks JSC,



4391 Venolife

heparin sodium,

dexpanthenol,

troxerutin

gel for external use

2,5mg/g+50mg/g+

20mg/g,

40g aluminium tube

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia C05BA53 1524330.12.2015

30.12.2020OTC

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia

4392 Venosmil hidrosmin capsules200mg,


FAES FARMA, S.A.,

C/ Maximo Aguirre

14, 48940, Leioa

Spain C05CA05 1687131.07.2017

31.07.2022PoM

FAES FARMA, S.A.,

C/ Maximo Aguirre

14, 48940, Leioa,

Spain

970

4393 Ventolinsalbutamol


2mg/5ml,

150ml glass bottle

Farmaclair, 440

Avenue du General

de Gaulle, 14200

Herouville- Saint-

Clair

France R03AC02 1545702.04.2016

02.04.2021PoM

Glaxo Wellcome UK

Limited, Stockley

Park West, Uxbridge,

Middlesex, UB 11

1BT, UK

4394 Ventolin Evohalersalbutamol


solution pressurised

inhalation

100mcg/dose, aluminium

container with inhaler

(200 doses)

Glaxo Wellcome

Production, Zone



Evreux

France R03AC02 1545102.04.2016

02.04.2021PoM

Glaxo Wellcome UK

Limited, Stockley


Middlesex, UB 11

1BT, UK

4395 Verapamil Alkaloid

verapamil

(verapamil

hydrochloride)

tablets coated80mg,


Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C08DA01 1645906.03.2017

06.03.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia


verapamil

(verapamil

hydrochloride)

tablets coated40mg,


Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C08DA01 1646006.03.2017

06.03.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia


verapamil

(verapamil

hydrochloride)


2,5mg/ml,


50/10x5/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C08DA01 1689708.08.2017

08.08.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

971

4398Verapress MR 240

Tablets

verapamil

(verapamil

hydrochloride)

tablets modified-

release

240mg,


Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB - batch


manufacturer,

packager - Dexcel

Ltd., 1 Dexcel St., Or-

Akiva 30600, Israel)

UK C08DA01 1258507.06.2013

07.06.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

4399 Vermox mebendazole tablets100mg,

in blister (6/1x6/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest- batch

releaser, Gedeon

Richter Romania S.A.,

99-105 Guza Voda

str., 540306, Targu-

Mures, Romania-bulk

manufacturer,

packager

Hungary P02CA01 1572122.06.2016

22.06.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

4400 Verona

tribullus terrestris,

withania somnifera,

mucuna pruriens,

argyreia speciosa

capsules

300mg+100mg+

25mg+60mg,


60)

Herbion Pakistan Pvt.

Ltd., Plot 30, Sector

28,Korangi Industrial

Area,Karachi

Pakistan G04BE30 1263825.06.2013

25.06.2018PoM

Herbion Pakistan Pvt.

Ltd., Plot 30, Sector

28,Korangi Industrial

Area,Karachi,

Pakistan

4401 Verospiron spironolactone tablets25mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C03DA01 1429919.03.2015

19.03.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

972

4402 Verospiron 50mg spironolactone tablets 50mg

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C03DA01 1401326.11.2014

26.11.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

4403 Verrufilm salicylic acid cutaneous solution

167mg/g,

10ml glass bottle-

applicator

Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels - batch

releaser, Farmalabor

Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal-bulk

manufacturer,

primary and

secondary packager

Belgium D11AF 1531704.02.2016

04.02.2021OTC

Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels, Belgium

4404 Vesicare

solifenacin

(solifenacin

succinate)

tablets film-coated

5mg,


30/3x10/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands G04BD08 1593929.08.2016

29.08.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

4405 Vesomnisolifencin,

tamsulosin

tablets film-coated

modified-release

6mg+0,4mg,

in blisters, (10/1x10/,

30/3x10/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel - packager,

batch releaser (Avara

Pharmaceutical

Tecnologies Inc., 3300

Marshall Avenue,

Norman, OK 73072,

USA - bulk

manufacturer)

the Netherlands G04CA53 13705/104.07.2017

24.07.2019PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

973

4406 Vessel Due F sulodexide capsules250LSU,


Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno

Italy B01AB11 1416324.12.2014

24.12.2019PoM

Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno, Italy

4407 Vessel Due F sulodexidesolution for i/v and

i/m injection

300LSU/ml,


Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno

Italy B01AB11 1416424.12.2014

24.12.2019PoM

Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno, Italy

4408 Vetbicine-3

benzathine

benzylpenicillin,

benzylpenicillin

sodium,

benzylpenicillin

procaine

powder lyophilized


injection

200000IU+ 200000IU+

200000IU,


"Sintez" OJSC, Pr.


Kurgan, 640008

Russia

QJ051RC24;

veterinary

drug

1553619.04.2016

19.04.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640008

4409 Vetbicine-5

benzathine

benzylpenicillin,

benzylpenicillin

procaine

powder lyophilized


injection

1200000IU+ 300000IU,


"Sintez" OJSC, Pr.


Kurgan, 640008

Russia

QJ51RC24;

veterinary

drug

1553719.04.2016

19.04.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640009

4410 Veyxyl LA 20%

amoxicillin

(amoxicillin

trihydrate)

suspension for

injection

200mg/ml,


Veyx-Pharma GmbH,

Sohreweg 6, 34639

Schwarzenborn-

batch releaser,

secondary packager,

VEYX PHARMA

B.V., Forellenweg 16,

Raamsdonksveer,

4941SJ, the

Netherlandsy- bulk

manufacturer,

primary packager

Germany

QJ01CA04;

veterinary

drug

1651117.03.2017

17.03.2022PoM

Veyx-Pharma GmbH,

Sohreweg 6, 34639

Schwarzenborn,

Germany

974

4411 Viagrasildenafil (sildenafil

citrate)tablets orodispersible

50mg,


8(/2x4/)

Fareva Amboise Zone

Industrielle, 29 route

des Industries, 37530

Poce-sur-Cisse

France G04BE03 13917/113.01.2016

29.10.2019PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA



50mg,

blister (1, 4/1x4/)

Fareva Amboise, Zone



Poce-sur-Cisse

France G04BE03 13918/111.08.2016

29.10.2019PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street New

York 10017, USA



100mg,

blister (1, 4/1x4/)

Fareva Amboise, Zone



Poce-sur-Cisse

France G04BE03 13919/111.08.2016

29.10.2019PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

4414 Vibrocil

dimethindene

(dimethindene

maleate),

phenylephrine

spray nasal0,25mg/ml+2,5mg/ml;

10ml in plastic container

Novartis Consumer


IÈtraz, 1260 Nyon)

Switzerland R01BA53 1289407.10.2013

07.10.2013OTC

Novartis Consumer


IÈtraz, 1260 Nyon,

Switzerland)

4415 Vibrocil

dimethindene

maleate,

phenylephrine

drops nasal0,25mg/ml+ 2,5mg/ml,

15ml glass vial

Novartis Consumer


IÈtraz, 269 1260

Nyon

Switzerland R01BA53 1305725.11.2013

25.11.2018OTC

Novartis Consumer


IÈtraz, 269 1260

Nyon, Switzerland

4416 Vicasol-Darnitsa

menadione

(menadione sodium

bisulfite)


10mg/ml,

1ml ampoules,


Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine B02BA02 12571/130.08.2013

06.06.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine

4417 Victoza liraglutidesolution for s/c

injection

6mg/ml,

3ml pre-filled pen (2)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10BX07 1562724.05.2016

24.05.2021PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

975

4418 Vigadexa

moxifloxacin

(moxifloxacin

hydrochloride),

dexamethasone

(dexamethasone

phosphate)

drops eye5mg/ml+1mg/ml, 5ml

plastic vial

Novartis Biociencias

S.A., avenue N.S. da

Assuncao,736 05359-

001 San Paulo

Brazil S01CA01 12185/122.06.2015

01.02.2018PoM

Novartis Biociencias

S.A., avenue N.S. da

Assuncao,736 05359-

001 San Paulo, Brazil

4419 Vigamox

moxifloxacin

(moxifloxacin

hydrochloride)

drops eye (solution)5mg/ml,

5ml plastic vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14,

Puurs, B-2870

Belgium S01AE07 1319610.01.2014

10.01.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14,

Puurs, B-2870,

Belgium

4420

Vinorelbine

10mg/ml

concentrate for

solution for

infusion

vinorelbine

(vinorelbine

tartrate)

concentrate for


10mg/ml,

1ml glass vial (1)

Accord Healthcare

Limited, Sage House,

319 Pinner Road, North

Harrow, Middlesex,

HA1 4HF - batch

releaser, Intas

Pharmaceuticals


458 & 191/218 P,



District-Ahmedabad,


bulk manufacturer,

Accord Healthcare


Homefield Business



packager

UK L01CA04 1692516.08.2017

16.08.2022PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

976

4421

Vinorelbine

10mg/ml

concentrate for

solution for

infusion

vinorelbine

(vinorelbine

tartrate)

concentrate for


10mg/ml,

5ml glass vial (1)

Accord Healthcare



Harrow, Middlesex,

HA1 4HF - batch

releaser, Intas

Pharmaceuticals


458 & 191/218 P,



District-Ahmedabad,


bulk manufacturer,

Accord Healthcare


Homefield Business



packager

UK L01CA04 1692616.08.2017

16.08.2022PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

4422 Vinorelbine Ebewe

vinorelbine

(vinorelbine

tartrate)

concentrate for

solution for i/v

infusion

10mg/ml,

5ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01CA04 1563724.05.2016

24.05.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

4423 Vinorelbine Ebewe

vinorelbine

(vinorelbine

tartrate)

concentrate for

solution for i/v

infusion

10mg/ml,

1ml glass vials (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01CA04 1563824.05.2016

24.05.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

4424 Vinpocetine vinpocetine solution for injection

5mg/ml,

2ml ampoules,

in blister

(5, 10, 5/1x5/, 10/2x5/)

Lekhim-Kharkiv JSC,


str., 61115 Kharkov

Ukraine N06BX18 1328204.03.2014

04.03.2019PoM

Lekhim-Kharkiv JSC,



Ukraine

977

4425 Vinpocetine vinpocetine solution for injection

5mg/ml,


ampoules label banderol

(10),2ml ampoules (10),

dividella

Open joint stock


zavod medicinskikh

preparatov" 64/27,



Belarus N06BX18 1354030.05.2014

30.05.2019PoM

Open joint stock


zavod medicinskikh

preparatov" 64/27,


222120, Minsk

region, Belarus

4426Vinpocetine Covex

5mgvinpocetine tablets

5mg,


50/2x25/)

Kern Pharma S.L.,

C/Venus, 72 Pol. Ind.

Colon II, 08228

Terrasa, (Barcelona)

Spain N06BX18 1614723.11.2016

23.11.2021PoM

Covex S.A., C/Acero,

25, Pol. Ind. Sur

28770 Colmenar

Viejo, (Madrid), Spain

4427 Vinpocetine forte vinpocetine tablets

10mg,


60/6x10/)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus N06BX18 1534826.02.2016

26.02.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

4428Vinpocetine tablets

5mgvinpocetine tablets

5mg,


50/5x10/)

Biocom JSC, 54

Chapaevsky Cr.,

Stavropol, 355016

Russia N06BX18 1270423.07.2013

23.07.2018PoM

Biocom JSC, 54

Chapaevsky Cr.,

Stavropol, 355016,

Russia

4429 Viperal

gyurza venom,

salicylic acid,

terpentine,

camphora

ointment for

external use

0,0176mg/g (16IU/100g)+

10mg/g+30mg/g+ 30mg/g,

25g aluminium tube

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaM02AX 13318

04.03.2014

04.03.2019OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

978

4430 Viprosal B

dry venom of vipera

berus, camphor

racemic, turpentine

oil, salicylic acid

ointment for

external use

0,05 IU/g+

30mg/g+30mg/g+ 10mg/g,

30g,50g, 75g aluminium

tube

Tallinn

Pharmaceutical Plant

JSC, Tondi 33, 11316

Tallinn

Estonia M02AX 1530304.02.2016

04.02.2021OTC

Grindeks JSC,



4431 Vireadtenofovir disoproxil


300mg,


Gilead Sciences

Ireland UC, IDA

Business and

Technology Park,

Carrigtohill, Co. Cork,

Ireland - packager,


GmbH Betriebsstatte

Oranienburg,

LehnitzstraBe 70-98

16515 Oranienburg,

Germany - bulk

manufacturer)

Ireland J05AF07 13780/111.01.2016

05.09.2019PoM


333 Lakeside Drive,

Foster City,CA 94404,

USA

4432 Vireadtenofovir disoproxil


300mg,


Gilead Sciences

Ireland UC, IDA

Business and

Technology Park,



GmbH Betriebsstatte

Oranienburg,


16515 Oranienburg,

Germany - bulk

manufacturer)

(Catalent Germany

Schorndorf GmbH,

Steinbeisstrasse 1 und


Germany - packager)

Ireland J05AF07 13781/111.01.2016

05.09.2019PoM


333 Lakeside Drive,

Foster City, CA

94404, USA

979

4433 Virgan ganciclovir gel eye

1,5mg/g,

5g tube and detachable

base

Farmila-Thea

Farmaceutici S.p.A.,

Via E. Fermi, 50-

20019 Settimo

Milanese (MI)

Italy S01AD09 1370624.07.2014

24.07.2019PoM

Laboratoires Thea, 12,

rue Louis Bleriot-

63017 Clermont-

Ferrand Cedex 2,

France

4434 Virogelspini aetheroleum,

silbiolgel

3mg/g+10mg/g, 15g

aluminium tube

LMP Ltd., 1, Vietalvas

street, Riga, LV-1009Latvia R01AX10 14860

18.09.2015

18.09.2020OTC

LMP Ltd., 1,


LV-1009, Latvia

4435 Virolex aciclovir tablets200mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J05AB01 1602717.10.2016

17.10.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4436 Virolex aciclovirpowder for solution

for infusion

250mg,

glass vial (5)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo


secondary packager,

GlaxoSmithKline

Manufacturing S.p.A.,

Strada Provinciale

Asolana, 90, 43056

San Polo di Torrile,

Parma, Italy- bulk

manufacturer,

primary packager

Slovenia J05AB01 1612210.11.2016

10.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4437 Visannedienogest

(micronised)tablets

2mg,


Bayer Weimar GmbH

& Co. KG,

Doebereinerstrasse

20, 99427 Weimar

Germany G03DB08 1307909.12.2013

09.12.2018PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353 Berlin,

Germany

980

4438 Visine

tetryzoline

(tetryzoline

hydrochloride)

drops eye 0,5mg/ml,

15ml plastic vial

Janssen

Pharmaceutica N.V.,


2340 Beerse

Belgium S01GA02 1693328.08.2017

28.08.2022OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

4439 Visipaque iodixanol solution for injection

320mg iodine/ml, 50ml

glass vials (10), 50ml

plastic vials (10)

GE Healthcare

Ireland, IDA Business

Park, Carrigtohill Co.

Cork

Ireland V08AB09 1430910.03.2015

10.03.2020PoM

GE Healthcare AS,

Nycoveien 1-2, P.O.

Box 4220 Nydalen,

NO-0401 Oslo,

Norway

4440 Visipaque iodixanol solution for injection320mg iodine/ml, 100ml

plastic vials (10)

GE Healthcare

Ireland, IDA Business

Park, Carrigtohill Co.

Cork

Ireland V08AB09 1431010.03.2015

10.03.2020PoM

GE Healthcare AS,

Nycoveien 1-2, P.O.

Box 4220 Nydalen,

NO-0401 Oslo,

Norway

4441 Vitalipid N adult

retinol (retinol

palmitate),

phytomenadione,

ergocalciferol, alpha-

tocopherol

emulsion for

infusion

99mcg/ml+ 15mcg/ml+

0.5mcg/ml+ 0.91mg/ml,


(10)

Fresenius Kabi AB,


75174

Sweden A11BA 1464603.07.2015

03.07.2020PoM

Fresenius Kabi

Deutschland GmbH,

61346 Bad Homburg,

v.d.H, Germany

4442 Vitalipid N infant

retinol (retinol

palmitate),

phytomenadione,

ergocalciferol, alpha-

tocopherol

emulsion for

infusion

69mcg/ml+ 20mcg/ml+

1mcg/ml+ 0.64mg/ml,


(10)

Fresenius Kabi AB,


75174

Sweden A11BA 1464703.07.2015

03.07.2020PoM

Fresenius Kabi

Deutschland GmbH,

61346 Bad Homburg,

v.d.H, Germany

4443 Vitamin A retinol acetate capsules33000IU,



26/3, Inzhenernaya

str., 220075, Minsk

Belarus A11CA01 1718330.11.2017

30.11.2022OTC


26, Inzhenernaya str.,

220075, Minsk,

Belarus

981

4444Vitamin B

Complex

vitamin B1, vitamin

B2, vitamin B6,

dexpanthenol,

nicotinamide


5mg/ml+2mg/ml+

2mg/ml+3mg/ml+

20mg/ml,

2ml ampoules,


bulk manufacturer,

primary packager -

Zahravi,

Pharmaceutical

Company, 19km

Tabriz- Tehran Road,

opposite to the

Agriculture Training

Center. P.O., Iran;

secondary packager,

batch releaser -

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA11BA 12306/1

18.02.2014

22.03.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building

Republic of Armenia

4445 Vitamin B complex

thiamine (thiamine

nitrate), riboflavin,

pyridoxine

(pyridoxine

hydrochloride),

nicotinamide

film-coated tablets 5mg+1mg+4mg+ 50mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria A11EX 1691708.08.2017

08.08.2022OTC

Sopharma JSC, str.

Iliensko shosse 16,


4446

Vitamin B complex

solution for

injection

thiamine (thiamine

hydrochloride),

riboflavin

(riboflavin sodium

phosphate),

pyridoxine

(pyridoxine

hydrochloride),

nicotinamide


i/m injection

5mg/ml+1mg/ml+

5mg/ml+50mg/ml, 2ml

ampoules (10)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria A11EX 1537526.02.2016

26.02.2021PoM

Sopharma JSC, str.

Iliensko shosse 16,


4447 Vitamin C ascorbic acid tablets250mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA11GA01 14480

30.04.2015

30.04.2020OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

982



Replek Farm Ltd,

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia A11GA01 1536426.02.2016

26.02.2021OTC

Esculap Ltd., 17/2, 1

block, Davidashen,

0054, Yerevan,

Republic of Armenia

4449 Vitamin C ascorbic acid capsules500mg,


"NOKI" JV LTD Co.,


region

Republic of


10.11.2016

10.11.2021OTC

"NOKI" JV LTD Co.,


region, Republic of

Armenia



Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


31.05.2017

31.05.2022OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

4451 Vitamin C-Asteria ascorbic acid tablets500mg,


Hankook Korus

Pharm Co., Ltd, 30,

Gangje-ro, Jecheon-Si,

Chungcheongbuk-do

Korea Sourth A11GA01 1486824.09.2015

24.09.2020OTC

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, South Korea

4452 Vitamin Ealfa-tocopherol

acetatecapsules

100IU,



26/3, Inzhenernaya

str., 220075, Minsk

Belarus A11HA03 1706805.10.2017

05.10.2022OTC


26/3, Inzhenernaya

str., 220075, Minsk,

Belarus

4453 VitangoRhodiola rosea root

dry extracttablets film-coated

200mg,


40/2x20/)

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Strasse 4, 76227

Karlsruhe

GermanyA13A;

herbal drug15851

20.07.2016

20.07.2021OTC

Dr. Willmar Schwabe

GmbH & Co. KG,

Willmar-Schwabe-

Strasse 4, 76227

Karlsruhe

983

4454 Vitaprost prostate extract suppositories rectal10mg,

(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia G04BX 16221/109.03.2017

08.12.2021OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

4455 Vitaprost Forte

samprost (dry

extract of calf

prostate)



Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia G04BX 12245/119.06.2013

07.03.2018OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

4456 Vitaprost Forte

samprost (dry

extract of calf

prostate)



Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia G04BX 1712807.11.2017

07.11.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

4457 Vitaprost Plus

samprost (extract of

prostate),

lomefloxacin

(lomefloxacin

hydrochloride)

suppositories rectal 100mg+400mg, (10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia G04BX 14923/109.02.2017

20.10.2020PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

4458 Vitasilk benzoyl peroxide gel for external use50mg/g,

25g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD10AE01 13126

10.01.2014

10.01.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

4459 Vit-B-Denk

thiamine (thiamine

hydrochloride)(vita

minB1), pyridoxine

(pyridoxine

hydrochloride)(vita

minB6)

tablets film-coated

100mg+200mg,


100/10x10/)

Denk Pharma GmbH


84529 Tittmoning

Germany A11DB 1623105.12.2016

05.12.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

984

4460 Vitol-140vitamin A, vitamin

D3, vitamin E

solution oily for i/m

or s/c injection

80000IU/ml+

40000IU/ml+ 20mg/ml,

100ml glass bottle

Interchemie werken


Vanapere tee 14,

Viimsi, Harju county-

bulk manufacturer,

primary packager,

batch releaser,

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands-

secondary packager

Estonia

QA11CB;

veterinary

drug

1533626.02.2016

26.02.2021PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

4461 Vitrum

vitamin A, vitamin D3,

vitamin E, vitamin C, vitamin

B1, vitamin B2, vitamin B6,

nicotinamide, vitamin B12,

folic acid, biotin, calcium

pantothenate, vitamin K1,

calcium (dicalcium

phosphate), magnesium

(magnesium oxide), potassium

(potassium chloride), iron

(ferrous fumarate), copper

(cupric oxide), zinc (zinc

oxide), chromium (chromium

chloride), manganese

(manganese sulfate), tin

(stannous chloride), nickel

(nickel sulfate), silicon (sodium

metasilicate), vanadium

(sodium metavanadate),

chloride (potassium chloride),

phosphorus (dibasic calcium

phosphate), molibdenum

(sodium molybdate), selenium

(sodium selenate), iodine

(potassium iodide)

tablets film-coated

5000IU+400IU+

30IU+60mg+

1,5mg+1,7mg+

2mg+20mg+6mg+

400mcg+30mcg+

10mg+25mcg+

162mg+100mg+

40mg+18mg+2mg+15mg+

25mg+ 2,5mg+10mcg+

5mcg+10mcg+

10mcg+36,3mg+

125mg+25mcg+

25mcg+150mcg,


60, 100, 130)

Unipharm Inc. (200

Hick str., Westbury,

New York 11590)

USA A11AA04 1296028.10.2013

28.10.2018OTC

Unipharm Inc. (350,

5th avenue, suite

6701, New York,

10118, USA)

4462Vitrum

Antioxidant

vitamin A, vitamin

C, vitamin E, zinc

(zinc oxide), copper

(cupric oxide),

manganese

(manganese sulfate),

selenium (sodium

selenate)

tablets film-coated

5000IU+250mg+

200IU+10mg+

1,1mg+2mg+ 20mcg,


Unipharm, Inc., 200


New York 11590

USA A11AA04 1318210.01.2014

10.01.2019OTC

Unipharm, Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

985

4463 Vitrum Baby


vitamin E, vitamin C,

vitamin B1, vitamin B2,


nicotinamide, biotin, folic

acid, pantothenic acid

(calcium pantothenate),

vitamin K1, calcium

(calcium carbonate),

magnesium (magnesium

oxide), iron (ferrous

fumarate), copper (cupric

oxide), zinc (zinc oxide),

manganese (manganese

sulfate monohydrate),

chromium (chromium

amino acid chelate),

molibdenum (sodium

molybdate), selen (sodium

selenate), phosphorus

(calcium hydrophosphate),

iodine (potassium iodide)

tablets chewable

1500IU+200IU+

6IU+60mg+

0,7mg+0,8mg+

1mg+1,1mcg+

10mg+20mcg+

150mcg+3mg+

10mcg+100mg+

40mg+9mg+1mg+

10mg+1mg+

20mcg+20mcg+

25mcg+20mg+ 80mcg,


60)

Unipharm Inc., 200


New York 11590

USA A11AA04 1235609.04.2013

09.04.2018OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

4464 Vitrum Beauty

betacarotene, vitamin D,

vitamin E, vitamin C, folic

acid, vitamin B1, vitamin

B2, vitamin B6, vitamin

B12, nicotinamide, biotin,

calcium pantothenate,

rutin, inositol, choline

tartrate, bioflavonoids,

betaine hydrochloride, para

aminobenzoic acid,

cysteine, methionine,

papain, calcium (calcium

hydrophosphate), iodine

(potassium iodide), iron,


oxide), phosphorus

(calcium hydrophosphate),

zinc (zinc oxide),


gluconate), selenium, boron

citrate

tablets film-coated

1700IU+67IU+

10IU+40mg+

133mcg+2mg+

2mg+5mg+4mcg+

10mg+133mcg+

10mg+10mg+

10mg+50mg+

20mg+10mg+

10mg+3,3mg+

3,3mg+3,3mg+

200mg+75mcg+

2mg+50mg+

155mg+5mg+

3,3mg+8,3mcg+

0,5mg+20mg,


60)

Unipharm Inc., 200


New York 11590

USA A11AB 1303225.11.2013

25.11.2018OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

986

4465Vitrum Cardio

Omega-3

omega-3

polyunsaturated

fatty acids ethyl

esters

((eicosapentaenoic

acid(EPA),docosahe

xaenoic acid(DHA),

alfa-

tocopherol(vitamin

E))

capsules

1000mg(300mg+

200mg+2mg),


Unipharm, Inc., 200


New York 11590

USA C10AX06 1317710.01.2014

10.01.2019OTC


5th avenue, suite

6701, New York,

10118, USA

4466 Vitrum Century



B1 , vitamin B2 , vitamin B6,


folic acid, biotin, calcium

pantothenate,vitamin K1,

calcium (dibasic calcium

phosphate), iron (ferrous

fumarate), zinc (zinc oxide),


oxide), phosphorus(dibasic

calcium phosphate), potassium

(potassium chloride), copper

(cupric oxide), manganese

(manganese sulfate) , iodine

(potassium iodide),

molybdenum(sodium

molybdate), selenium (sodium

selenate), chromium


nickel(nickel sulfate),

silicon(sodium metasilicate),

vanadium(sodium

metavanadate), boron

tablets coated

6000IU+400IU+

45IU+60mg+

1,5mg+1,7mg+

3mg+20mg+

25mcg+200mcg+

30mcg+10mg+

10mcg+200mg+

9mg+15mg+

100mg+48mg+

72mg+2mg+2,5mg+150mc

g+25mcg+

20mcg+100mcg+

5mcg+10mcg+

10mcg+150mcg,


100)

Unipharm, Inc., 200


New York 11590

USA A11AA04 1318010.01.2014

10.01.2019OTC


5th avenue, suite

6701, New York,

10118, USA

987

4467 Vitrum Junior




vitamin B6,

nicotinamide, vitamin

B12, vitamin K1, biotin,

folic acid, calcium

pantothenate, calcium

(dicalcium phosphate),



fumarate), copper


oxide), manganese


chromium (chromium

chloride), molibdenum

(sodium molybdate),

phosphorus (dicalcium

phosphate), iodine

(potassium iodide)

tablets chewable

5000IU+400IU+

30IU+300mg+

1,5mg+1,7mg+

2mg+20mg+

6mcg+10mcg+ 45mcg+

400mcg+10mg+ 160mg+

40mg+18mg+

2mg+15mg+ 1mg+20mcg+

20mcg+50mg+ 150mcg,


60)

Unipharm Inc., 200


New York 11590

USA A11AA04 1223807.03.2013

07.03.2018OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

4468 Vitrum Kids




vitamin B6, nicotinamide,

vitamin B12, biotin, folic

acid, pantothenic acid,

potassium (potassium

carbonate), magnesium

(magnesium phosphate),

iron (ferrous fumarate),

copper (cupric oxide), zinc

(zinc oxide), manganese

(manganese citrate),

selenium (sodium selenate),

chromium (chromium

aminoat), phosphorus

(magnesium phosphate),

iodine (potassium iodide)

tablets chewable

2500IU+400IU+

15IU+60mg+

1,05mg+1,2mg+

1,05mg+13,5mg+

4,5mcg+20mcg+

300mcg+5mg+

100mg+40mg+

15mg+1mg+10mg+1mg+2

5mcg+ 20mcg+50mg+

150mcg,


60)

Unipharm, Inc., 200


New York 11590

USA A11AA04 1317810.01.2014

10.01.2019OTC


5th avenue, suite

6701, New York,

10118, USA

988

4469 Vitrum Memoryginkgo biloba dry


60mg,


Unipharm Inc., 200


New York 11590

USAN06DX02;

herbal drug13070

09.12.2013

09.12.2018OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

4470 Vitrum Osteomag

vitamin D3,

calcium (calcium

carbonate),

magnesium

(magnesium oxide),

zinc(zinc oxide),

copper (copper

oxide), manganese


boron(sodium

borate)

tablets film-coated

200IU+600mg+

40mg+7,5mg+1mg+1,8mg

+250mcg,


60)

Unipharm Inc., 200


New York 11590

USA A11AA03 1213801.02.2013

01.02.2018OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

4471Vitrum

Performance



B1, vitamin B2, vitamin B6,


folic acid, biotin, pantothenic

acid (calcium pantothenate),

vitamin K1, calcium (dibasic

calcium phosphate, calcium

carbonate), potassium

(potassium chloride), iron

(ferrous fumarate), magnesium

(magnesium oxide), copper


oxide),chlorid (potassium

chloride), chromium



sulfate), tin(stannous chloride),

nickel(nickel sulfate),

silicon(silicon dioxide),

vanadium(sodium

metavanadate), boron(sodium

borate), phosphorus(dibasic

calcium phosphate),

molybdenum (sodium

molybdate), selenium (sodium

selenate), iodine (potassium

iodide), ginseng root extract

tablets film-coated

5000IU+400IU+

60IU+120mg+

4,5mg+5,1mg+

6mg+40mg+

18mcg+400mcg+

40mcg+10mg+

25mcg+100mg+

80mg+18mg+40mg+2mg+

15mg+ 72mg+120mcg+

4mg+10mcg+ 5mcg+4mg+

10mcg+60mcg+

48mg+75mcg+

70mcg+150mcg+ 50mg,


60)

Unipharm, Inc., 200


New York 11590

USA A11AB 1318310.01.2014

10.01.2019OTC


5th avenue, suite

6701, New York,

10118, USA

989

4472Vitrum Prenatal

Forte

betacarotene, vitamin A

, vitamin D3, vitamin E,

vitamin C, vitamin B1,


nicotinamide, vitamin

B12, folic acid, biotin,

pantothenic acid

(calcium pantothenate),

calcium (dicalcium

phosphate), magnesium

(magnesium oxide), iron

(ferrous fumarate),

copper (cupric iide), zinc

(zinc oxide), mnganese


chromium (chromium

chloride), molibdenum

(sodium molybdate),

selenium (sodium

selenate), iodine

(potassium iodide)

tablets film-coated

2500IU+2500IU+

400IU+30IU+

120mg+3mg+

3,4mg+10mg+

20mg+12mcg+

800mcg+30mcg+

10mg+200mg+

25mg+60mg+

2mg+25mg+ 5mg+25mcg+

25mcg+20mcg+ 150mcg,


100)

Unipharm Inc., 200


New York 11590

USA A11AA04 1223707.03.2013

07.03.2018OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

4473Vitrum Super-

stress

vitamin E, vitamin

C, folic acid,

vitamin B1, vitamin

B2, nicotinamide,

vitamin B6, vitamin

B12, biotin,

pantothenic acid

(calcium

pantothenate), iron

(ferrous fumarate)

tablets film-coated

30IU+500mg+

400mcg+15mg+

10mg+100mg+

5mg+12mcg+

45mcg+20mg+ 27mg,


60)

Unipharm, Inc., 200


New York 11590

USA A11AA01 1317610.01.2014

10.01.2019OTC


5th avenue, suite

6701, New York,

10118, USA

990

4474 Vitrum Teenager





nicotinamide, folic acid,

calcium pantothenate,

biotin, vitamin K1,

phosphorus (dicalcium

phosphate), calcium

(dicalcium phosphate,

calcium carbonate),



fumarate), copper (cupric

oxide), zinc (zinc oxide),

iodine (potassium iodide),


sulfate), selenium (sodium

selenate), chromium


molybdenum (sodium

molybdate)

tablets chewable

3000IU+200IU+

10IU+100mg+

1,5mg+1,7mg+

2mg+6mcg+20mg+400mc

g+-5mg+30mg+

10mcg+50mg+

200mg+50mg+

10mg+2mg+15mg+150mc

g+1mg+ 30mcg+20mcg+

20mcg,


60)

Unipharm, Inc., 200


New York 11590

USA A11AA04 1318110.01.2014

10.01.2019OTC


5th avenue, suite

6701, New York,

10118, USA

4475 Vitrum Vision

vitamin C, vitamin

E, betacarotene,

lutein, zeaxanthin,

copper (copper

sulfate), zinc (zinc

oxide)

tablets film-coated

225mg+36mg+

1,5mg+2,5mg+

0,5mg+1mg+5mg, in

plastic container, (30, 60)

Unipharm Inc., 200


New York 11591

USA A11AB 1213901.02.2013

01.02.2018OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

4476Vitrum Vision

Forte

vitamin C, vitamin

E, vitamin B2,

vitamin A, lutein,

zeaxanthin, rutin,

selenium, zinc(zinc

oxide), bilberry

extract

tablets film-coated

60mg+10mg+

1,2mg+1,5mg+

6mg+0,5mg+

25mg+25mcg+

5mg+60mg,


60(/4x15/)

Unipharm Inc. 200


New York 11590

USA A11AB 1366308.07.2014

08.07.2019OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York, N.Y.

10118, USA

4477 ViziDolketorolac (ketorolac

tromethamine)eye drops

5mg/ml,

5ml dropper vial

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01BC05 13344

17.03.2014

17.03.2019PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

991

4478 ViziPres

dorzolamide

(dorzolamide

hydrochloride)

drops eye20mg/ml,


Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01EC03 15818

20.07.2016

20.07.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

4479 Vizoptin

tetryzoline

(tetryzoline

hydrochloride)

drops eye (solution)0,5mg/ml,


S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania S01GA02 1706705.10.2017

05.10.2022OTC

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

4480 Voltarendiclofenac

(diclofenac sodium)solution for injection

75mg/3ml,

3ml ampoules (5)

Novartis Pharma

Stein AG,


4332 Stein

Switzerland M01AB05 1326610.03.2014

10.03.2019PoM

Novartis Pharma AG,


Basel, Switzerland



25mg/ml,

3ml ampoules (5)

Lek Pharmaceuticals


57, 1526 Ljubljana

Slovenia M01AB05 1480704.09.2015

04.09.2020PoM

Novartis Pharma AG,


Basel, Switzerland


(diclofenac sodium)

tablets gastro-

resistant

25mg,



ve Tarim Urunleri

San.Ve Tic. A.S.,


Dedepasa Cadessi N

17 (11. Sok N 2)

34912, Kurtkoy,

Istanbul

Turkey M01AB05 1653727.03.2017

27.03.2022PoM

Novartis Pharma AG,


Basel, Switzerland

992


(diclofenac sodium)

tablets gastro-

resistant

50mg,



ve Tarim Urunleri

San.Ve Tic. A.S.,


Dedepasa Cadessi N

17 (11. Sok N 2)

34912, Kurtkoy,

Istanbul

Turkey M01AB05 1653827.03.2017

27.03.2022PoM

Novartis Pharma AG,


Basel, Switzerland


(diclofenac sodium)suppositories

25mg,


Delpharm Huningue


Chapelle, 68330

Huningue

France M01AB05 1658403.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland



100mg,

in blister (5)

Delpharm Huningue


Chapelle, 68330

Huningue

France M01AB05 1658503.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland



50mg,


Delpharm Huningue


Chapelle, 68330

Huningue

France M01AB05 1658603.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

4487 Voltaren Emulgel

diclofenac

(diclofenac

diethylamine)

gel for external use

10mg/g,

20g aluminium tube and

20g aluminium laminated

tube

Novartis Consumer



269, 1260 Nyon

Switzerland M02AA15 1344216.04.2014

16.04.2019OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

4488 Voltaren Emulgel

diclofenac

(diclofenac

diethylamine)

gel for external use20mg/g,

50g, 100g laminated tube

Novartis Consumer



269, 1260 Nyon


04.09.2020OTC

Novartis Consumer

Health Schweiz S.A.,

6343 Rish,

Switzerland

993

4489 Voltaren Emulgeldiclofenac

(diclofenac sodium)gel for external use

10mg/g,

20g, 50g and 100g

laminated tube

Novartis Consumer



269, 1260 Nyon


30.11.2022OTC

Novartis Consumer



269, 1260 Nyon,

Switzerland

4490 Voltaren Rapid

diclofenac

(diclofenac

potassium)

tablets sugar-coated25mg,


Novartis Urunleri,


Dedepasa Cadessi N

17 ( 11. Sok N 2)

34912, Kurtkoy,

Istanbul

Turkey M01AB05 1355706.06.2014

06.06.2019PoM

Novartis Pharma AG,

56 Lichtstrasse, 4056

Basel, Switzerland

4491 Voltaren Rapid

diclofenac

(diclofenac

potassium)

tablets sugar-coated

50mg,


20/2x10/)

Novartis Urunleri,


Dedepasa Cadessi N

17 ( 11. Sok N 2)

34912, Kurtkoy,

Istanbul

Turkey M01AB05 1355806.06.2014

06.06.2019PoM

Novartis Pharma AG,

56 Lichtstrasse, 4056

Basel, Switzerland

4492 Voltaren Rapid

diclofenac

(diclofenac

potassium)




ve Tarim Urunleri

San.Ve Tic. A.S.,


Dedepasa Cadessi N

17 (11. Sok N 2)

34912, Kurtkoy,

Istanbul

Turkey M01AB05 1658703.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

4493 Voltaren Rapid

diclofenac

(diclofenac

potassium)




ve Tarim Urunleri

San.Ve Tic. A.S.,


Dedepasa Cadessi N

17 (11. Sok N 2)

34912, Kurtkoy,

Istanbul

Turkey M01AB05 1658803.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

994

4494 Voltaren Retarddiclofenac

(diclofenac sodium)

tablets prolonged-

release film-coated

75mg,




131, 80058 Torre

Annunziata

Italy M01AB05 1344416.04.2014

16.04.2019PoM

Novartis Pharma AG,


Basel, Switzerland

4495 Voltaren Retarddiclofenac

(diclofenac sodium)

tablets prolonged-

release

75mg,




131, 80058 Torre

Annunziata (NA)

Italy M01AB05 1658903.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

4496 Votrient pazopanib tablets film-coated400mg,




09400 Aranda de

Duero, Burgos

Spain L01XE11 1432310.03.2015

10.03.2020PoM

Glaxo Group Ltd.,



TW8 9GS, UK





09400 Aranda de

Duero, Burgos

Spain L01XE11 1432410.03.2015

10.03.2020PoM

Glaxo Group Ltd.,



TW8 9GS, UK





09400 Aranda de

Duero, Burgos-batch

releaser, packager,

Glaxo Operations UK

Ltd, Priory Street,


SG12 0DJ, UK- bulk

manufacturer

Spain L01XE11 1656603.04.2017

03.04.2022PoM

Novartis Pharma AG,


Basel, Switzerland

995

4499 Vulnusanstabilized lye

Solilugointment

120mg/g,

45g aluminium tube

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria D03AX 1217901.02.2013

01.02.2018PoM

Sopharma JSC, str.

Iliensko shosse 16,


4500 Vurdondiclofenac


25mg/ml,


(5)

Help S.A., Pedini


45501

Greece M01AB05 1372724.07.2014

24.07.2019PoM

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece


(diclofenac sodium)

tablets gastro-

resistant

25mg,


Help S.A., Pedini


45500

Greece M01AB05 1411529.12.2014

29.12.2019PoM

Medicus S.A., 10

Valaoritou str., GR

144 52,

Metamorphosis,

Attika, Greece


(diclofenac sodium)suppositories rectal

100mg

(10/2x5)

Help S.A., Pedini


45500

Greece M01AB05 1465303.07.2015

03.07.2020PoM

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece


(diclofenac sodium)suppositories rectal

50mg

(10/2x5/)

Help S.A., Pedini


45500

Greece M01AB05 1465403.07.2015

03.07.2020PoM

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece


(diclofenac sodium)

tablets slow release

film-coated

100mg,


Help S.A., Pedini


45500

Greece M01AB05 1477003.08.2015

03.08.2020PoM

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece

996


(diclofenac sodium)

tablets gastro-

resistant

50mg,


Help S.A., Pedini


45500

Greece M01AB05 1477103.08.2015

03.08.2020PoM

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece

4506 Vurdon

diclofenac

(diclofenac

diethylammonium)

gel for external use10mg/g,

25g aluminium tube

Help S.A., Pedini


45500

Greece M02AA15 15767/225.04.2017

07.04.2021OTC

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece

4507 Warfarinwarfarin (warfarin

sodium)tablets

2,5mg,


100/5x20/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus B01AA03 1509215.12.2015

15.12.2020PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

4508 Warfarin Nycomed warfarin (warfarin

sodium) tablets

2,5mg,


100), (50/1x50/,

100/1x100/)

Takeda Pharma Sp.z

o.o., 12 Ksiestwa

Lowickiego st., 99-

420 Lyszkowice

Poland B01AA03 1693628.08.2017

28.08.2022PoM

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

4509 Warfarin Orionwarfarin (warfarin

sodium)tablets

3mg,


100)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland B01AA03 1272623.07.2013

23.07.2018PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

4510 Warfarin Orionwarfarin (warfarin

sodium)tablets

5mg,


100)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland B01AA03 1272723.07.2013

23.07.2018PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

4511 Water for injection water for injectionsolvent for

parenteral use

2ml ampoule,


Lekhim-Kharkiv JSC,


str., 61115 Kharkov

Ukraine V07AB 1479804.09.2015

04.09.2020PoM

Lekhim-Kharkiv JSC,



Ukraine

997

4512 Water for injection water for injectionsolvent for

parenteral use

5ml ampoules,


Lekhim-Kharkiv JSC,


str., 61115 Kharkov

Ukraine V07AB 1479904.09.2015

04.09.2020PoM

Lekhim-Kharkiv JSC,



Ukraine

4513 Water for injection water for injection solvent for

parenteral use

2ml,

2ml ampoules(10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

Armenia V07AB 16928

16.08.2017

16.08.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

4514 Wilate 1000

human blood

coagulation factor

VIII, human von

Willebrand factor

powder for solution

for i/v injection

1000IU/10ml+

1000IU/10ml,


glass vial, equipment pack

with disposable syringe,

transfer set (double ended

needle and filter needle)

infusion set, N 2 alcohol

swabs

Octapharma

Pharmazeutica

Produktionsges.

m.b.H. Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD06 13049/119.12.2013

25.11.2018PoM

Octapharma

Pharmazeutica

Produktionsges.

m.b.H. Oberlaaer

Strasse 235, A-1100

Vienna, Austria

4515 Wilate 500

human blood

coagulation factor

VIII, human von

Willebrand factor

powder for solution

for i/v injection

500IU/5ml+ 500IU/5ml,


glass vial, equipment pack

with disposable syringe,

transfer set (double ended

needle and filter needle)

infusion set, (2) alcohol

swabs

Octapharma

Pharmazeutica

Produktionsges.

m.b.H. Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD06 1304825.11.2013

25.11.2018PoM

Octapharma

Pharmazeutica

Produktionsges.

m.b.H. Oberlaaer

Strasse 235, A-1100

Vienna, Austria

4516 Wilprafen

josamycin

(josamycin

propionate)


in blister (10)

Temmler Werke

GmbH,

Weihenstephaner

Strasse 28, 81673

Munchen

Germany J01FA07 12281/119.01.2015

22.03.2018PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

998

4517 Wilprafen josamycin tablets film-coated500mg,


Dragenopharm

Apotheker Puschl


84529 Tittmoning

Germany J01FA07 1634830.12.2016

30.12.2021PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

4518 Wilprafen Solutab

josamycin

(josamycin

propionate)



Temmler Werke

GmbH,

Weihenstephaner

strasse 28, 81673

Munchen - batch

releaser, dosage form

manufacturer

(packager - C.P.M.

Contract Pharma

GmbH & Co.

KG,Gutenberg strasse

1, 83052 Bruckmuhl,

Bavaria, Germany)

Germany J01FA07 1228222.03.2013

22.03.2018PoM

Astellas Pharma

Europe B. V.,

Elisabethhof 19, 2353

EW Leiderdorp, the

Netherlands

4519 Wilprafen Solutab

josamycin

(josamycin

propionate)



Famar Lyon, 29

Avenue Charles de

Gaulle, 69230 Saint

Genis Laval

France J01FA07 1486424.09.2015

24.09.2020PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

4520 Winch 150mg fluconazole capsules150mg,

in blister (2)

Special Product s Line

S.p.A., Via

Campobello, 15,

00040 Pomezia

(Rome)

Italy J02AC01 1220907.03.2013

07.03.2018PoM

So.Se. Pharm S.r.l.,

Via dei Castelli

Romani 22, 00040

Pomezia (Rome),

Italy

4521 Wobenzym

pancreatin, papain,

rutin, bromelain,

trypsin, lipase,

amylase,

chymotrypsin

tablets gastro-

resistant

345U+90U+ 50mg+225U+

360U+34U+50U+ 300U,


200/10x20/),


Mucos Emulsions

GmbH, Miraustrasse

17, D-13509 Berlin

Germany L03AX 1375805.08.2014

05.08.2019OTC

Mucos Pharma

GmbH & Co. KG,

Miraustrasse 17, D-

13509 Berlin,

Germany

999

4522Wokhardt Cold

Relief

paracetamol,

caffeine,

phenylephrine

(phenylephrine

hydrochloride)

capsules hard300mg+25mg+ 5mg,


CP Pharmaceuticals

Ltd, Ash Road North

Wrexham Industrial

Estate LL13 9 UF -


form manufacturer -

Custom

Pharmaceuticals

Ltd,Conway

str.,Hove,East

Sussex,BN3 3LW, UK)

UK N02BE51 1233003.04.2013

03.04.2018OTC

Wockhardt UK

Ltd.,UK Ash Road

North Wrexham

Industrial Estate LL

13 9 UF, UK

4523 Xalatan latanoprost drops eye50mcg/ml,

2,5ml plastic container


Belgium N.V.,

Rijksweg 12, B-2870

Puurs

Belgium S01EE01 1308909.12.2013

09.12.2018PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

4524 Xalkori crizotinib capsules

200mg,


60/6x10/)


Deutschland GmbH,

Germany

Betriebsstatte

Freiburg,

Mooswaldallee 1,

79090 Frieburg

Germany L01XE16 1369324.07.2014

24.07.2019PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

4525 Xalkori crizotinib capsules

250mg,


60/6x10/)


Deutschland GmbH,

Germany

Betriebsstatte

Freiburg,

Mooswaldallee 1,

79090 Frieburg

Germany L01XE16 1369424.07.2014

24.07.2019PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

4526 Xarelto rivaroxaban tablets film-coated10mg,

in blister (10)

Bayer Pharma AG, D-

51368 Leverkusen Germany B01AF01 12565

06.06.2013

06.06.2018PoM

Bayer Pharma AG, D-

13342, Berlin,

Germany

1000



Bayer Pharma AG, D-

51368 Leverkusen Germany

B01AF01;

new

indication

12566/106.06.2013

06.06.2018PoM

Bayer Pharma AG, D-

13342, Berlin,

Germany



Bayer Pharma AG, D-

51368 Leverkusen Germany

B01AF01;

new

indication

12567/106.06.2013

06.06.2018PoM

Bayer Pharma AG, D-

13342, Berlin,

Germany

4529 Xefocam lornoxicam tablets film-coated8mg,


Takeda GmbH,

Betriebsstatte

Oranienburg,

Lehnitzstrasse 70-98,

16515 Oranienburg

Germany M01AC05 1455309.06.2015

09.06.2020PoM

Takeda Austria

GmbH, St. Peter

strasse 25, A-4020

Linz, Austria

4530 Xefocam lornoxicam

powder lyophilized


and i/m injection

8mg; (5) glass vial

Takeda Austria

GmbH, St. Peter

Strasse 25, A-4020

Linz - batch releaser,

packager,

Wasserburger

Arzneimittelwerk

GmbH, Herderstrasse

2, D-83512

Wasserburg,

Germany - bulk

manufacturer

Austria M01AC05 1704625.09.2017

25.09.2022PoM

Takeda Austria

GmbH, St. Peter

Strasse 25, A-4020

Linz, Austria

4531 Xefocam Rapid lornoxicam tablets film-coated8mg,


Takeda GmbH,

Betriebsstatte

Oranienburg,


16515 Oranienburg-

batch releaser,

packager, Takeda

Pharma

A/S,Apotekerstien 9,

9500 Hobro, Denmark-

bulk manufacturer

Germany M01AC05 1496918.11.2015

18.11.2020PoM

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

1001

4532 Xefocam Rapid lornoxicam tablets film-coated8mg,


Takeda GmbH,

Betriebsstatte

Oranienburg,


16515 Oranienburg

Germany M01AC05 1503502.12.2015

02.12.2020PoM

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

4533 Xeloda capecitabine tablets film-coated500mg,


F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel -

batch releaser, F.

Hoffmann-La Roche

Ltd., Wurmisweg, CH-

4303, Kaiseraugst,

Switzerland-packager,

Productos Roche S.A.

de C.V., Via Isidro

Fabela Nte. 1536-B,

CP 50030 Col. Parque

Industrial TToluca,

Edo de Mexico,

Mexico-bulk

manufacturer

Switzerland L01BC06 1476303.08.2015

03.08.2020PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel

Switzerland

4534 Xenical orlistat capsules hard120mg,


Roche SpA, Via

Morelli 2, 20090,

Segrate - bulk

manufacturer, batch

releaser (F.Hoffmann-

La Roche Ltd.,

Wurmisweg, 4303

Kaiseraugst,

Switzerland -

packager)

Italy A08AB01 1383918.09.2014

18.09.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

1002

4535 Xeplion

paliperidone

(paliperidone

palmitate)

suspension for

injection prolonged-

release

50mg/0,5ml,

0.5ml pre-filled syringe

(1) and (2) needles

Janssen

Pharmaceutica N.V.,


2340 Beerse

Belgium N05AX13 12498/120.08.2015

01.06.2018PoM

Janssen Cilag

International NV,


2340 Beerse, Belgium

4536 Xeplion

paliperidone

(paliperidone

palmitate)

suspension for i/m


release

75mg/0.75ml, 0.75mg

pre-filled syringe (1) and

(2) needles

Janssen

Pharmaceutica N.V.,


2340 Beerse

Belgium N05AX13 14390/120.08.2015

16.04.2020PoM

Janssen Cilag

International NV,



4537 Xeplion

paliperidone

(paliperidone

palmitate)

suspension for i/m


release

100mg/1ml,


and (2) needles

Janssen

Pharmaceutica N.V.,


2340 Beerse

Belgium N05AX13 14391/120.08.2015

16.04.2020PoM

Janssen Cilag

International NV,



4538 Xeplion

paliperidone

(paliperidone

palmitate)

suspension for i/m


release

150mg/1.5ml, 1.5ml pre-

filled syringe (1) and (2)

needles

Janssen

Pharmaceutica N.V.,


2340 Beerse

Belgium N05AX13 14392/120.08.2015

16.04.2020PoM

Janssen Cilag

International NV,



4539 Xgeva denosumab solution for injection70mg/ml,

1,7ml glass vial

Amgen Europe B.V.,

Minervum 7061, NL-

4817 ZK Breda -

packager, batch


manufacturer -

Amgen

Manufacturing

Limited, State Road

31, Km 24.6 Juncos,

00777-4060, Puerto

Rico)

the Netherlands M05BX04 1301125.11.2013

25.11.2018PoM

Amgen Europe B.V.,

Minervum 7061, NL-

4817 ZK Breda, the

Net

4540 Xolair omalizumabpowder for solution

for injection

150mg,

glass vial (1) and 2ml

solvent in ampoule

Novartis Pharma

Stein AG,


4332 Stein

Switzerland R03DX05 1559203.05.2016

03.05.2021PoM

Novartis Pharma AG,


Basel, Switzerland

1003

4541 Xtandi enzalutamide capsules40mg,

in blister (112/4x28/7x4/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel - secondary

packager, batch

releaser, Catalent

Pharma Solutions

LLC, 2725 Scherer

Drive, St. Petersburg,

33716-1016, USA-

bulk manufacturer,

Packaging

Coordinators Inc.,

2200 Lake Shore Dr

Woodstock, Illinois

60098, USA-primary

packager

the Netherlands

L02BB04;

new

indication

13976/126.11.2014

26.11.2019PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

4542 Xylaxylazine (xylazine


20mg/ml,

50ml glass bottle

Interchemie werken


Vanapere tee 14,

Viimsi, Harju county-

bulk manufacturer,

primary packager,

batch releaser,

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands-

secondary packager

Estonia

QN05CM92;

veterinary

drug

1438116.04.2015

16.04.2020PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

4543 Xylestesin-A


hydrochloride),

epinephrine

(epinephrine

hydrochloride)



3M Deutschland

GmbH, ESPE Platz

82229 Seefeld

Germany N01BB52 1288325.09.2013

25.09.2018PoM

3M Deutschland

GmbH, Carl-Schurz

Strasse 1, 42453

Neuss, Germany

1004

4544 Xylo-Nazal

xylometazoline

(xylometazoline

hydrochloride)

drops nasal1mg/ml,

10ml plastic bottle

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania R01AA07 1671223.05.2017

23.05.2022OTC

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

4545 Xylopan

xylometazoline

(xylometazoline

hydrochloride),

dexpanthenol

drops nasal1mg/ml+50mg/ml,

5ml and 10ml plastic vial

Arsanit Ltd, 110

Yerevanyan str.,


secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,


Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01АB06 17054

05.10.2017

05.10.2022OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

4546 Xylopan

xylometazoline

(xylometazoline

hydrochloride),

dexpanthenol

spray nasal


(100 dose) glass or plastic

vial with pump dispenser

Arsanit Ltd, 110

Yerevanyan str.,


secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,


Armenia-bulk

manufacturer,

primary packager

Republic of

Armenia R01АB06 16900

08.08.2017

08.08.2022OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

4547 Xylopan Kids

xylometazoline

(xylometazoline

hydrochloride),

dexpanthenol

drops nasal0,5mg/ml+ 50mg/ml,

5ml and10ml plastic vial

Arsanit Ltd, 110

Yerevanyan str.,


secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,


Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01АB06 17055

05.10.2017

05.10.2022OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

1005

4548 Xylopan Kids

xylometazoline

(xylometazoline

hydrochloride),

dexpanthenol

spray nasal

0,5mg/ml+ 50mg/ml,



dispenser

Arsanit Ltd, 110

Yerevanyan str.,


secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,


Armenia-bulk

manufacturer,

primary packager

Republic of

Armenia R01АB06 16899

08.08.2017

08.08.2022OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

4549 Xymelin

xylometazoline

(xylometazoline

hydrochloride)


10ml plastic bottle

Nycomed Danmark

ApS, Langebjerg 1,

DK-4000 Roskilde -


form manufacturer -

Nycomed Pharma AS,

Solbaerveien 5, NO-

2409 Elverum,

Norway)

Denmark R01AA07 1259621.06.2013

21.06.2018OTC

Nycomed Danmark

ApS, Langebjerg 1DK-

4000 Roskilde,

Denmark

4550 Xymelin

xylometazoline

(xylometazoline

hydrochloride)

drops nasal1mg/ml,

10ml plastic bottle

Nycomed Danmark

ApS, Langebjerg 1,

DK-4000 Roskilde -


form manufacturer -

Nycomed Pharma AS,

Solbaerveien 5, NO-

2409 Elverum,

Norway)

Denmark R01AA07 1259721.06.2013

21.06.2018OTC

Nycomed Danmark


4000 Roskilde,

Denmark

1006

4551 Xymelin

xylometazoline

(xylometazoline

hydrochloride)

spray nasal0,5mg/ml,


Nycomed Danmark

ApS, Langebjerg 1,

DK-4000 Roskilde -


form manufacturer -

Nycomed Pharma AS,

Solbaerveien 5, NO-

2409 Elverum,

Norway)

Denmark R01AA07 1259821.06.2013

21.06.2018OTC

Nycomed Danmark


4000 Roskilde,

Denmark

4552 Xymelin

xylometazoline

(xylometazoline

hydrochloride)

spray nasal1mg/ml,

10ml,15ml glass bottle

Nycomed Danmark

ApS, Langebjerg 1,

DK-4000 Roskilde -


form manufacturer -

Nycomed Pharma AS,

Solbaerveien 5, NO-

2409 Elverum,

Norway)

Denmark R01AA07 1259921.06.2013

21.06.2018OTC

Nycomed Danmark


4000 Roskilde,

Denmark

4553 Xymelin

xylometazoline

(xylometazoline

hydrochloride)


10ml vial-dropper

Takeda GmbH,

Robert-Bosch-Str. 8,

78224 Singen

Germany R01AA07 1596615.09.2016

15.09.2021OTC

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

4554 Xymelin

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

0,5mg/ml,

15ml glass vial with pump

dispenser

Takeda GmbH,


78224 Singen

Germany R01AA07 15967/120.05.2017

15.09.2021OTC

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

4555 Xymelin

xylometazoline

(xylometazoline

hydrochloride)

drops nasal1mg/ml,

10ml vial-dropper

Takeda GmbH,


78224 Singen

Germany R01AA07 1596815.09.2016

15.09.2021OTC

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

1007

4556 Xymelin

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

1mg/ml,

15ml glass vial with pump

dispenser

Takeda GmbH,


78224 Singen

Germany R01AA07 15969/120.05.2017

15.09.2021OTC

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

4557 Xyzal

levocetirizine

(levocetirizine

dihydrochloride)



Aesica

Pharmaceuticals S.r.l.,

Via Praglia, 15-10044

Pianezza (TO) -

packager, batch

releaser (UCB

Farchim S.A., Z.I de

Planchy, Chemin de

Croix Blanche 10, CH-

1630 Bulle,

Switzerland - bulk

manufacturer)

Italy R06AE09 13981/125.07.2017

26.11.2019OTC

GlaxoSmithKline

Export Ltd, 980 Great

West Road,


TW8 9GS, UK

4558 Yarinadrospirenone,

ethinylestradioltablets film-coated

3mg+30mcg, blister

(21/1x21/)

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin-batch

releaser, packager,

Bayer Weimer GmbH

und Co.KG,

Doebereinerstrasse

20, 99427, Weimer,

Germany-bulk

manufacturer

Germany G03AA12 14428/116.01.2017

14.04.2020PoM

Bayer Pharma AG, D-

13342, Berlin,

Germany

4559 Yaz

light pink tablet-

drospirenone,

ethinylestradiol,

white tablet-

inactive

tablets film-coated

3mg+0,02mg, (28/24 light

pink tablet+4white

tablet/) in blister

Bayer Weimar GmbH

& Co. KG,


99427 Weimar

Germany G03AA12 1564724.05.2016

24.05.2021PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

1008

4560 Yaz plus

pink tablet-

drospirenone,

ethinyl estradiol,

levomefolate

(levomefolate

calcium); light

orange tablet-

levomefolate

(levomefolate

calcium)

tablets film-coated

pink tablet-3mg+0,02mg+

0,451mg,

light orange tablet-

0,451mg,

(28/24 pink tablet+4light

orange tablet/),

in blister

Bayer Weimar GmbH

& Co. KG,


99427 Weimar

Germany G03AA12 1485204.09.2015

04.09.2020PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353 Berlin,

Germany

4561 Zalain

sertaconazole

(sertaconazole

nitrate)

cream for external

use

20mg/g,

20g aluminium tube


PLC, 1165 Budapest,






Valles, Barcelona,

Spain-bulk

manufacturer,

packager

Hungary D01AC14 1601906.10.2016

06.10.2021OTC


PLC, 1106 Budapest,


Hungary

4562 Zalain

sertaconazole

(sertaconazole

nitrate)

cream for external

use

20mg/g,

20g aluminium tube




Valles, Barcelona

Spain D01AC14 1602006.10.2016

06.10.2021OTC


PLC, 1106 Budapest,


Hungary

4563 Zalain

sertaconazole

(sertaconazole

nitrate)

suppositories vaginal300mg,

(1)

Trommsdorff GmbH

& Co. KG,

Arzneimittel,


6, 52477, Alsdorf

Germany G01AF19 1615723.11.2016

23.11.2021PoM


PLC, 1106 Budapest,


Hungary

1009

4564 Zalain

sertaconazole

(sertaconazole

nitrate)

suppositories vaginal300mg,

(1)


PLC, 1165 Budapest,



Trommsdorff GmbH

& Co. KG,

Arzneimittel,


6, 52477, Alsdorf,

Germany- bulk

manufacturer,

packager

Hungary G01AF19 1615823.11.2016

23.11.2021PoM


PLC, 1106 Budapest,


Hungary

4565 Zanidip-Recordati

lercanidipine

(lercanidipine

hydrochloride)

tablets film-coated

10mg,


28/1x28/)

Recordati Industria

Chimica e

Farmaceutica S.p.A.,

Via Civitali, 1-20148

Milano

Italy C08CA13 1577711.07.2016

11.07.2021PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

4566 Zanidip-Recordati

lercanidipine

(lercanidipine

hydrochloride)



Recordati Industria

Chimica e

Farmaceutica S.p.A.,

Via Civitali, 1-20148

Milano

Italy C08CA13 1577811.07.2016

11.07.2021PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

4567 Zentel albendazole tablets400mg,

in blister (1)

GlaxoSmithKline

South Africa Ltd., 39

Hawkins Avenue,

Epping Industria 1,

Cape Town, 7460

South Africa P02CA03 1421103.02.2015

03.02.2020PoM

GlaxoSmithKline

South Africa Ltd., 39

Hawkins Avenue,

Epping Industria 1,

Cape Town, 7460,

South Africa

4568 Zentel albendazole suspension oral40mg/ml,


Farmaclair, 440

Avenue du General

de Gaulle, 14200

Herouville- Saint-

Clair

France P02CA03 1434225.03.2015

25.03.2020PoM

Laboratoire


route de Versallies

78163 Marly-Le-Roi

Cedex, France

1010

4569 ZentiMox 400 albendazole tablets chewable

400mg,


10/1x10/, 100/10x10/,

100/10x10x1/, 100/2x50/)

Perdaman

Pharmaceuticals Pvt.

Ltd., G/5 & G/6

Gorwa B.I.D.C., City

Vadodara-390 016,

dist. Vadodara

India P02CA03 13009/121.01.2014

25.11.2018PoM

Perdaman

Pharmaceuticals Pvt.

Ltd., Level-11, A-111,

Himalaya House, KG

Marg, Cannaught

Place, New Delhi-

110001, India

4570 Zestaval 200 albendazole tablets film-coated200mg,

in blister (2)

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon


Cyprus P02CA03 1248817.05.2013

17.05.2018PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

4571 Zidin

chlorhexidine

(chlorhexidine

bigluconate)

suppositories vaginal16mg

(10/2x5/)


Ararat province,

Masis city, Masis


22

Republic of

ArmeniaG01AX 13319

04.03.2014

04.03.2019OTC


Ararat province,

Masis city, Masis


22, Republic of

Armenia

4572 Zimagra-ODS 50sildenafil (sildenafil

citrate)films orodispersible

50mg,

sachets (4, 10/1x10,

100/10x10x1)


B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India G04BE03 15886/127.10.2016

23.08.2021PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

4573 Zimfil-ODF 10 tadalafil films orodispersible

10mg,

sachets (4/1x4, 10/1x10,

10x4x1, 10x10x1)


B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur,

Maharashtra

India G04BE08 16127/108.02.2017

10.11.2021PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

1011

4574 Zimfil-ODF 20 tadalafil films orodispersible

20mg,

sachets (4/1x4, 10/1x10,

10x4x1, 10x10x1)


B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur,

Maharashtra

India G04BE08 16128/108.02.2017

10.11.2021PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

4575 Zimsar-25losartan (losartan


25mg,



B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India C09CA01 1471916.07.2015

16.07.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

4576 Zimsar-50losartan (losartan


50mg,



B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India C09CA01 1460903.07.2015

03.07.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

4577 Zinacef

cefuroxime

(cefuroxime

sodium)

powder for solution

for injection

750mg,

glass vial

GlaxoSmithKline

Manufacturing SpA,

Via A. Fleming, 2,

Verona, 37135

Italy J01DC02 1410118.12.2014

18.12.2019PoM

GlaxoSmithKline

Manufacturing SpA,

Via A. Fleming, 2,

Verona, 37135, Italy

4578 Zinaprimsulfamethazine,

trimethoprimsolution for injection

200mg/ml+ 40mg/ml,

100ml glass vial

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19

Spain

QJ01E;

veterinary

drug

1507807.12.2015

07.12.2020PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

1012

4579 Zineryterythromycin, zinc

acetate dihydrate

powder for solution

for external use

40mg/ml+12mg/ml,

plastic container, 30ml

solvent in plastic

container and applicator

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands D10AF52 1725108.12.2017

08.12.2022PoM

LEO Pharma A/S,

Industriparken 55,

DK-2750 Ballerup,

Denmark

4580 ZinMax

cefuroxime

(cefuroxime

sodium)

powder for solution

for injection

750mg,

glass vial

Protech Biosystems


146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001

India J01DC02 1277314.08.2013

14.08.2018PoM

Protech Biosystems

Pvt. Ltd., Plot No

145-146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001,

India

4581 Zinnatcefuroxime

(cefuroxime axetil)tablets coated

250mg,

in blister (10)

Glaxo Operations UK

Limited, Harmire

Road, Barnard Castle,

Durham, DL12 8DT

UK J01DC02 1257506.06.2013

06.06.2018PoM

Glaxo Wellcome UK

Limited, Stockley


Middlesex, UB 11

1BT, UK

4582 Zinnatcefuroxime

(cefuroxime axetil)

granules for oral

suspension

125mg/5ml,

100ml glass bottle,

measuring cup 37ml and

5ml measuring spoon

Glaxo Operations UK

Limited, Harmire


Durham, DL12 8DT

UK J01DC02 15196/107.06.2016

30.12.2020PoM

Glaxo Wellcome UK

Limited, Stockley


Middlesex, UB 11

1BT, UK

4583 ZirteXyz

levocetirizine

(levocetirizine

dihydrochloride)

tablets

5mg,


100/10x10/, 200/20x10/,

100/5x20/, 200/10x20/,

400/20x20/)

Vaishali

Pharmaceuticals, 7th

K.M Stone, Jansath

Road, Muzaffar Nagar

India R06AE09 12984/128.04.2014

28.10.2018OTC

Vaishali

Pharmaceuticals,

4299/3, Ansari Road,

Darya Ganj, New

Delhi-110 002, India

4584 ZO-20 simvastatin tablets coated20mg,


GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia C10AA01 1519230.12.2015

30.12.2020PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


1013

4585 Zobral

levocetirizine

(levocetirizine

dihydrochloride)

tablets film-coated5mg.


Delorbis


17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia

Cyprus R06AE09 13491/102.12.2014

15.05.2019OTC

Delorbis


17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia, Cyprus

4586 Zocardis 30zofenopril

(zofenopril calcium)tablets film-coated

30mg,


A.Menarini

Manufacturing


S.r.l.,Via Campo Di

Pile, 67100 L Aquila

Italy C09AA15 1527304.02.2016

04.02.2021PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

4587 Zocardis 7,5zofenopril

(zofenopril calcium)tablets film-coated

7,5mg,


A.Menarini

Manufacturing


S.r.l.,Via Campo Di

Pile, 67100 L Aquila

Italy C09AA15 1527204.02.2016

04.02.2021PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

4588 Zocor simvastatin tablets film-coated

10mg,


28/2x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -

packager, batch

releaser (bulk


Sharp & Dohme Ltd.,

Shotton Lane,

Cramlington,

Northumberland

NE23 3JU, United

Kingdom)


21.06.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

1014

4589 Zocor simvastatin tablets film-coated

20mg,


28/2x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -

packager, batch

releaser (bulk


Sharp & Dohme Ltd.,

Shotton Lane,

Cramlington,

Northumberland

NE23 3JU, United

Kingdom)


21.06.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

4590 Zocor Forte simvastatin tablets film-coated40mg,

in blister (14)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -

packager, batch

releaser (bulk


Sharp & Dohme Ltd.,

Shotton Lane,

Cramlington,

Northumberland

NE23 3JU, United

Kingdom)


21.06.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

4591 Zodaccetirizine (cetirizine

dihydrochloride)tablets film-coated

10mg,

in blister (10)

Zentiva, k.s., U


Praha 10, Dolni

Mecholupy

Czech Republic R06AE07 1321624.02.2014

24.02.2019OTC

Zentiva, k.s., U

kabelovny 130, 102

37 Praha 10, Dolni

Mecholupy, Czech

Republic

4592 Zofran

ondansetron

(ondansetron

hydrochloride

dihydrate)


i/m injection

2mg/ml,

4ml ampoules (5)

GlaxoSmithKline

Manufacturing S.p.A.,

Strada Provinciale

Asolana, 90, 43056

San Polo di Torrile,

Parma

Italy A04AA01 14841/115.02.2017

04.09.2020PoM

Novartis Pharma AG,


Basel, Switzerland

1015

4593 Zolaxa olanzapine tablets film-coated5mg,


Pharmaceutical

Works Polpharma


83-200 Starogard

Gdanski

Poland N05AH03 1552919.04.2016

19.04.2021PoM

Pharmaceutical

Works Polpharma



Gdanski, Poland

4594 Zolaxa ODT olanzapine tablets orodispersible

10mg,


30/3x10/, 56/4x14/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland N05AH03 1695705.09.2017

05.09.2022PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski, Poland


5mg,


30/3x10/, 56/4x14/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland N05AH03 1695805.09.2017

05.09.2022PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski, Poland


20mg,


30/3x10/, 56/4x14/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland N05AH03 1695905.09.2017

05.09.2022PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski, Poland


15mg,


30/3x10/, 56/4x14/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski

Poland N05AH03 1696005.09.2017

05.09.2022PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska


Gdanski, Poland

1016

4598Zoledro-Denk

4mg/5mlzoledronic acid

concentrate for

solution for i/v

infusion

0.8mg/ml,


Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln,

Niedersachsen, 31789

Germany M05BA08 1439816.04.2015

16.04.2020PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

4599 Zoledronic acid zoledronic acid

powder lyophilized

for solution for

infusion

4mg,

10ml glass vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus M05BA08 1529104.02.2016

04.02.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

4600Zoledronic Acid

Accordzoledronic acid

concentrate for

solution for i/v

infusion

0.8mg/ml,

5ml plastic vial (1)

Accord Healthcare



Harrow, Middlesex,

HA1 4HF-batch

releaser, Intas

Pharmaceuticals


458 & 191/218 P,



District-Ahmedabad,


bulk manufacturer,

primary packager,

Accord Healthcare


Homefield Business



secondary packager

UK M05BA08 1490602.10.2015

02.10.2020PoM

Accord Healthcare


319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

UK

4601 Zoloftsertraline (sertraline

hydrochloride)tablets coated

50mg,


Haupt Pharma Latina

S.r.l., S.S 156, KM 47,

600 Borgo San

Michele, 04100 Latina

Italy N06AB06 1672120.05.2017

20.05.2022PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1017

4602 Zolomax alprazolam tablets0,25mg,


Grindex JSC, Krustpils

street 53, Riga, LV-



manufacturer -

Dragenopharm

Apotheker Puschl


84529 Tittmoning,

Bavaria, Germany)

Latvia N05BA12 1315610.01.2014

10.01.2019PoM/UC

Grindex JSC,



4603 Zolomax alprazolam tablets0,5mg,






manufacturer -

Dragenopharm

Apotheker Puschl


84529 Tittmoning,

Bavaria, Germany)

Latvia N05BA12 1315710.01.2014

10.01.2019PoM/UC

Grindex JSC,



4604 Zolomax alprazolam tablets1mg,






manufacturer -

Dragenopharm

Apotheker Puschl


84529 Tittmoning,

Bavaria, Germany)

Latvia N05BA12 1315810.01.2014

10.01.2019PoM/UC

Grindex JSC,



4605 Zometa

zoledronic acid

(zoledronic acid

monohydrate)

concentrate for


0.8mg/ml,

5ml glass vial (1)

Novartis Pharma

Stein AG,


4332 Stein

Switzerland M05BA08 1649015.03.2017

15.03.2022PoM

Novartis Pharma AG,


Basel, Switzerland

1018

4606 Zometa

zoledronic acid

(zoledronic acid

monohydrate)

solution for infusion0,04mg/ml,

100ml glass vial

Novartis Pharma

Stein AG,


4332 Stein

Switzerland M05BA08 1649115.03.2017

15.03.2022PoM

Novartis Pharma AG,


Basel, Switzerland

4607 Zondan

ondansetron

(ondansetron

hydrochloride

dihydrate)


4ml ampoules (5)

Incepta

Pharmaceuticals

Limited, Dewan Idris

Road, Zirabo, Savar,

Dhaka

Bangladesh A04AA01 1728826.12.2017

26.12.2022PoM

Incepta

Pharmaceuticals

Limited, Dewan Idris

Road, Zirabo, Savar,

Dhaka, Bangladesh

4608 Zovirax aciclovircream for external

use

50mg/g,

2g aluminium tube

Glaxo Operations UK

Limited, Harmire


Co Durham DL12

8DT

UK D06BB03 1476403.08.2015

03.08.2020OTC

GlaxoSmithKline

Consumer


West Road,


TW8 9GS, UK

4609 Zyllt

clopidogrel

(clopidogrel

hydrogen sulphate)

tablets film-coated

75mg,


28/4x7/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia B01AC04 1494620.10.2015

20.10.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4610 Zyllt

clopidogrel

(clopidogrel

hydrogen sulphate)

tablets film-coated

75mg,


28/4x7/)

KRKA-FARMA d.

o.o., DPC

Jastrebarsko,

Cvetkovic bb

Croatia B01AC04 1507107.12.2015

07.12.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1019

4611 Zyprexa olanzapine tablets coated5mg,


Lilly S.A., Avda de la

Industria 30, 28108

Alcobendas-Madrid,

Spain - batch releaser,


manufacturer - Lilly

del Caribe Inc.,

Puerto Rico Industrial

Park, 12,6km 65th

Infantry Road,

Carolina, 00985

Puerto Rico)

Spain N05AH03 12163/120.07.2015

01.02.2018PoM

Eli Lilly Nederland

B.V., Grootslag 1-5,

NL-3991 RA Houten,

the Netherlands




Industria 30, 28108

Alcobendas-Madrid,



manufacturer - Lilly

del Caribe Inc.,

Puerto Rico Industrial

Park, 12,6km 65th

Infantry Road,

Carolina, 00985

Puerto Rico)

Spain N05AH03 12164/120.07.2015

01.02.2018PoM

Eli Lilly Nederland


NL-3991 RA Houten,

the Netherlands




Industria 30, 28108

Alcobendas-Madrid

Spain N05AH03 1445904.05.2015

04.05.2020PoM

Eli Lilly Nederland


NL-3991 RA Houten,

the Netherlands




Industria 30, 28108

Alcobendas-Madrid

Spain N05AH03 1446004.05.2015

04.05.2020PoM

Eli Lilly Nederland


NL-3991 RA Houten,

the Netherlands

1020

4615

Zyprexa VeloTab

10mg

orodispersible

tablets




Industria 30, 28108

Alcobendas-Madrid,



manufacturer -

Catalent UK Swindon

Zydis Ltd., Frankland

Road, Blagrove,

Swindon, Wiltshire,

SN5 8RU, UK )

Spain N05AH03 12269/128.03.2013

07.03.2018PoM

Eli Lilly Nederland


NL-3991 RA Houten,

the Netherlands

4616

Zyprexa VeloTab

5mg orodispersible

tablets




Industria 30, 28108

Alcobendas-Madrid,



manufacturer -

Catalent UK Swindon

Zydis Ltd., Frankland

Road, Blagrove,

Swindon, Wiltshire,

SN5 8RU, UK )

Spain N05AH03 12268/128.03.2013

07.03.2018PoM

Eli Lilly Nederland


NL-3991 RA Houten,

the Netherlands

4617 Zyrteccetirizine (cetirizine

dihydrochloride)tablets film-coated

10mg,

in blister (7/1x7/)

Aesica



Pianezza (TO)-

packager, batch

releaser, UCB

Farchim S.A., Z.I. de

Planchy, Chemin de

Croix Blanche 10, CH-

1630 Bulle,

Switzerland- bulk

manufacturer

Italy R06AE07 14447/110.10.2017

04.05.2020OTC

GlaxoSmithKline


West Road,


TW8 9GS, UK

1021

4618 Zyrteccetirizine (cetirizine

dihydrochloride)drops oral

10mg/ml,

10ml glass bottle

Aesica



Pianezza (TO)

Italy R06AE07 1681610.07.2017

10.07.2022OTC

GlaxoSmithKline


West Road,


TW8 9GS, UK

4619 Zytiga

abiraterone

(abiraterone

acetate)

tablets250mg,




Borgo San Michele,

Latina, 04010 -

secondary packager,

batch releaser

(Patheon Inc., 2100

Syntex Court,

Mississauga, Ontario,

L5N 7K9, Canada-

bulk manufacturer,

primary packager)

Italy L02BX03 1392029.10.2014

29.10.2019PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

4620 Zyvox linezolid tablets film-coated600mg,

in blister (10)

Pfizer


99 Jardines str.,

Caguas, Puerto Rico

00725

USA J01XX08 1227122.03.2013

22.03.2018PoM

Pharmacia and

Upjohn Company,

7000 Portage road,

Kalamazoo MI 49001,

USA

4621 Zyvox linezolid solution for infusion2mg/ml,

300ml plastic packs (10)

Fresenius Kabi Norge

AS, P.O. Box 430,

1753 Halden

Norway J01XX08 1269323.07.2013

23.07.2018PoM

Pfizer AS, P.O. Box 3,

1324 Lysaker,

Norway

4622 Zyvox linezolid tablets film-coated600mg,


Pfizer


1.9 km Road 689,

Vega Baja, Puerto

Rico 00693

USA J01XX08 1481504.09.2015

04.09.2020PoM

Pfizer H.C.P.

Corporation, 235,


York, 10017, USA

1-Anatomical, Therapeutic Chemical Classification, 2- PoM - Prescription only medicine, 3- OTC - Over-the-Counter, 4- PoM\UC - Prescription-only medicine, Under Controlled

1022

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