LIST OF REGISTRED DRUGS IN ARMENIA (01.04.2017 ... - · PDF fileDrug form Dose and packaging...

21
N Trade name International nonproprietary name (generic) or active ingredients name Drug form Dose and packaging Manufacturer Country ATC 1 code Registration number Term of registration Legal Status for Supply License holder 1 Adenuric 120mg febuxostat tablets film-coated 120mg, in blister (28/2x14/, 56/4x14/, 84/6x14/) Menarini-Von Heyden GmbH, Leipziger Strasse 7- 13, 01097 Dresden- batch releaser, packager, Patheon France, 40 Boulevard de Champaret, 38 300 Bourgoin Jallieu, France- bulk manufacturer Germany M04AA03 16558 03.04.2017 03.04.2022 PoM 2 Menarini International Operations Luxembourg S.A.,1, avenue de la Gare, 1611, Luxembourg 2 Adenuric 80mg febuxostat tablets film-coated 80mg, in blister (28/2x14/, 56/4x14/) Menarini-Von Heyden GmbH, Leipziger Strasse 7- 13, 01097 Dresden- batch releaser, packager, Patheon France, 40 Boulevard de Champaret, 38 300 Bourgoin Jallieu, France- bulk manufacturer Germany M04AA03 16559 03.04.2017 03.04.2022 PoM Menarini International Operations Luxembourg S.A.,1, avenue de la Gare, 1611, Luxembourg 3 Adrenalin-Zdorovye epinephrine (epinephrine hydrotartrate) solution for injection 1,82mg/ml, 1ml ampoules (5, 10), 1ml ampoules in blister (5, 10/1x10/, 10/2x5/) Pharmaceutical Company "Zdorovye" LLC, 61013, Kharkov, Shevchenko str., 22 Ukraine C01CA24 16620 25.04.2017 25.04.2022 PoM Pharmaceutical Company "Zdorovye" LLC, 61013, Kharkov, Shevchenko str., 22, Ukraine LIST OF REGISTRED DRUGS IN ARMENIA (01.04.2017-30.04.2017) 1

Transcript of LIST OF REGISTRED DRUGS IN ARMENIA (01.04.2017 ... - · PDF fileDrug form Dose and packaging...

Page 1: LIST OF REGISTRED DRUGS IN ARMENIA (01.04.2017 ... - · PDF fileDrug form Dose and packaging Manufacturer Country ATC1 code Registration number Term of registration ... 21 Cordarone

N Trade name

International

nonproprietary name

(generic) or active

ingredients name

Drug formDose and

packagingManufacturer Country ATC1 code

Registration

number

Term of

registration

Legal Status

for SupplyLicense holder

1 Adenuric 120mg febuxostat tablets film-coated

120mg,

in blister (28/2x14/,

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

Menarini-Von

Heyden GmbH,

Leipziger Strasse 7-

13, 01097 Dresden-

batch releaser,

packager, Patheon

France, 40 Boulevard

de Champaret, 38

300 Bourgoin Jallieu,

France- bulk

manufacturer

Germany M04AA03 1655803.04.2017

03.04.2022PoM2

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

2 Adenuric 80mg febuxostat tablets film-coated

80mg,

in blister (28/2x14/,

56/4x14/)

Menarini-Von

Heyden GmbH,

Leipziger Strasse 7-

13, 01097 Dresden-

batch releaser,

packager, Patheon

France, 40 Boulevard

de Champaret, 38

300 Bourgoin Jallieu,

France- bulk

manufacturer

Germany M04AA03 1655903.04.2017

03.04.2022PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

3 Adrenalin-Zdorovye

epinephrine

(epinephrine

hydrotartrate)

solution for

injection

1,82mg/ml,

1ml ampoules (5,

10), 1ml ampoules

in blister (5,

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

Pharmaceutical

Company "Zdorovye"

LLC, 61013,

Kharkov,

Shevchenko str., 22

Ukraine C01CA24 1662025.04.2017

25.04.2022PoM

Pharmaceutical

Company

"Zdorovye" LLC,

61013, Kharkov,

Shevchenko str., 22,

Ukraine

LIST OF REGISTRED DRUGS IN ARMENIA

(01.04.2017-30.04.2017)

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4 Amlodipine-Zdorovyeamlodipine (amlodipine

besilate)tablets

5mg,

in blister (20/2x10/,

30/3x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013,

Kharkov,

Shevchenko str., 22

Ukraine C08CA01 1657103.04.2017

03.04.2022PoM

Pharmaceutical

Company

"Zdorovye" LLC,

61013, Kharkov,

Shevchenko str., 22,

Ukraine

5 Amlodipine-Zdorovyeamlodipine (amlodipine

besilate)tablets

10mg,

in blister (20/2x10/,

30/3x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013,

Kharkov,

Shevchenko str., 22

Ukraine C08CA01 1657203.04.2017

03.04.2022PoM

Pharmaceutical

Company

"Zdorovye" LLC,

61013, Kharkov,

Shevchenko str., 22,

Ukraine

6 Anaprilinpropranolol (propranolol

hydrochloride)tablets

40mg,

in blister (50/5x10/)

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

Belarus C07AA05 1659910.04.2017

10.04.2022PoM

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

7 Atenolol atenolol tablets

50mg,

in blisters

(30/2x15/)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia C07AB03 14276/103.04.2017

19.03.2020PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

8 Berlipril 10enalapril (enalapril

maleate)tablets

10mg,

in blister (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 C09AA02 1655703.04.2017

03.04.2022PoM

Berlin-Chemie

A.G., Glienicker

Weg 125, 12489

Berlin, Germany

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9 Berlipril 20enalapril (enalapril

maleate)tablets

20mg,

in blister (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 C09AA02 1655603.04.2017

03.04.2022PoM

Berlin-Chemie

A.G., Glienicker

Weg 125, 12489

Berlin, Germany

10 Betadina povidone-iodinesolution for

external use

100mg/ml,

20ml, 30ml and

50ml plastic vial

Pharmaceutical

Company "NOKA"

Ltd, Davtashen 2nd

block 21/1, Yerevan

Republic of

ArmeniaD08AG02 16613

10.04.2017

10.04.2022OTC3

Pharmaceutical

Company "NOKA"

Ltd, Davtashen 2nd

block 21/1,

Yerevan, Republic

of Armenia

11 Bromhexine

bromhexine

(bromhexine

hydrochloride)

tablets8mg,

in blister (50/5x10/)

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

Belarus R05CB02 1661925.04.2017

25.04.2022OTC

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

12Bupivacaine

hydrochloride 0,5%

bupivacaine

(bupivacaine

hydrochloride)

solution for

injection

5mg/ml,

10ml ampoules (10)

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw

Poland N01BB01 1663625.04.2017

25.04.2022PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24

str., 01-207

Warsaw, Poland

13 Ceftriaxoneceftriaxone (ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

1g,

glass vial (1, 10,

270)

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus J01DD04 15409/105.04.2017

09.03.2021PoM

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64,

Chapaev str.,

Borisov 222518,

Minsk region,

Belarus

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14 Ceftriaxoneceftriaxone (ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

500mg,

glass vial (1, 10,

270)

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus J01DD04 15416/105.04.2017

09.03.2021PoM

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64,

Chapaev str.,

Borisov 222518,

Minsk region,

Belarus

15 Ceftriaxone sodiumceftriaxone (ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

1000mg,

glass vial (1, 20, 40)

Belmedpreparaty

RUE, Grodninsky

region, Lida, str.

Kachana,19/8

Belarus J01DD04 1663525.04.2017

25.04.2022PoM

Belmedpreparaty

RUE, 220007,

Minsk, Fabritsius

St., 30, Belarus

16 Celex celecoxib capsules200mg

in blister (10/1x10/)

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

ArmeniaM01AH01 16642

25.04.2017

25.04.2022PoM

Tufenkji Group

LLC, Kochinyan

13/16, Yerevan,

Republic of

Armenia

17 Chymotrypsin Crystalline chymotrypsin

lyophilisate for

solution for

injection

10mg,

glass vial (10)

"BIOFARMA" "PP"

LLC, 37, Kyivska Str.,

Bila Tserkva, 09100,

Kyiv region

Ukraine D03B 1657803.04.2017

03.04.2022PoM

"BIOFARMA" "PP"

LLC, 37, Kyivska

Str., Bila Tserkva,

09100, Kyiv region,

Ukraine

18 CinnoVex interferon beta-1a

powder lyophilized

for solution for i/m

injection

30mcg (6MIU),

(4 /1 glass vial with

powder +1pre-filled

syringe with 1ml

solvent+ 2 needles/)

CinnaGen Co., West

6th St., 3rd Sq.,

Simindasht Industrial

Area, Karaj, Alborz

Iran L03AB07 1657403.04.2017

03.04.2022PoM

CinnaGen Co.,

West 6th St., 3rd

Sq., Simindasht

Industrial Area,

Karaj, Alborz, Iran

4

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19 Clopidolclopidogrel (clopidogrel

bisulfate)tablets film-coated

75mg,

in blister (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

ArmeniaB01AC04 16643

25.04.2017

25.04.2022PoM

Tufenkji Group

LLC, Kochinyan

13/16, Yerevan,

Republic of

Armenia

20 Contractubex

extract cepae, heparin

(heparin sodium),

allantoin

gel for external use

100mg/g+50IU/g+

10mg/g,

20g aluminium

tube

Merz Pharma GmbH

& Co. KGaA,

Ludwigstrasse 22,

Reinheim, Hessen,

64354

Germany C05BA53 1656803.04.2017

03.04.2022OTC

Merz

Pharmaceuticals

GmbH,

Eckenheimer

Landstrasse 100,

60318

Frankfurt/Main,

Germany

21 Cordarone

amiodarone

(amiodarone

hydrochloride)

tablets scored200mg,

in blister (30/2x15/)

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd.,

2112 Veresegyhaz,

Levai u. 5

Hungary C01BD01 15080/103.04.2017

07.12.2020PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain

Rolland, 75014

Paris, France

22 Cycloferon

acridonacetic acid, N-

methyl glucamin

(meglumin)

solution for i/m and

i/v injection

125mg/ml+

96,3mg/ml,

2ml ampoules,

in blister (5)

Scientific

Technological

Pharmaceutical Firm

"POLISAN" Ltd,

192102, Saint

Petersburg, Salova st.

72, building 2, lit. A

Russia L03AX 1664125.04.2017

25.04.2022PoM

Scientific

Technological

Pharmaceutical

Firm "POLISAN"

Ltd, 192102, Saint

Petersburg, Salova

st. 72, building 2,

lit. A, Russia

5

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23 Dexalfen

dexketoprofen

(dexketoprofen

trometamol)

solution for i/m and

i/v injection

25mg/ml,

2ml ampoules,

in blister (5/1x5/)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,

village Belikovo,

rural settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia M01AE17 1660010.04.2017

10.04.2022PoM

"Sotex"PharmFirm"

CJSC, Bld. 11,

village Belikovo,

rural settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

24 Dexatobromtobramycin,

dexamethasone

drops eye

(suspension)

3mg/ml+1mg/ml,

5ml plastic vial

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A

Romania S01CA01 1663325.04.2017

25.04.2022PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str.

Eroilor, Nr. 1A,

Romania

25 Doktor Mom

adhatoda vasika, aloe

barbadensis, ocimum

sanctum, inula

racemosa, zingiber

officinale, curcuma

longa, solanum indicum,

piper cubeba,

glycyrrhiza glabra,

terminalia belerica,

levomenthol

syrup

6mg/ml+5mg/ml+

10mg/ml+2mg/ml+

1mg/ml+5mg/ml+

2mg/ml+1mg/ml+

6mg/ml+2mg/ml+

0,6mg/ml,

100ml, 150ml

plastic bottle and

measuring cup

Unique

Pharmaceutical

Laboratories, Plot N0

215, 216, G.I.D.C

Industrial Area,

Panoli: 394 116,

Gujarat State

IndiaR05CA10;

herbal drug13257/1

18.04.2017

24.02.2019OTC

Johnson & Johnson

LLC, 121614,

Moscow,

Krylatskaya str., 17,

building 2, Russia

26 Feiba 25U/mlfactor VIII inhibitor

bypassing activity

powder and solvent

for solution for

infusion

500U (25U/ml),

glass vial with

powder (1), 20ml

glass vial with

solvent (1), BaxJect

ii Hi-Flow (1),

disposable syringe

(1), disposable

needle (1), butterfly

needle with clamp

(1)

Baxter AG,

Industriestrasse 67, A-

1221 Vienna

Austria B02BD02 1661110.04.2017

10.04.2022PoM

Baxter AG,

Industriestrasse 67,

A-1221 Vienna,

Austria

6

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27 Feiba 50U/mlfactor VIII inhibitor

bypassing activity

powder and solvent

for solution for

infusion

1000U (50U/ml),

glass vial with

powder (1), 20ml

glass vial with

solvent (1), BaxJect

ii Hi-Flow (1),

disposable syringe

(1), disposable

needle (1), butterfly

needle with clamp

(1)

Baxter AG,

Industriestrasse 67, A-

1221 Vienna

Austria B02BD02 1661210.04.2017

10.04.2022PoM

Baxter AG,

Industriestrasse 67,

A-1221 Vienna,

Austria

28 Femara letrozole tablets film-coated2,5mg,

in blister (30/3x10/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland L02BG04 1661412.04.2017

12.04.2022PoM

Novartis Pharma

AG, 35,

Lichtstrasse, 4056

Basel, Switzerland

29 Fexodine

fexofenadine

(fexofenadine

hydrochloride)

tablets film-coated120mg,

in blister (10/1x10/)

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

ArmeniaR06AX26 16608

10.04.2017

10.04.2022OTC

Tufenkji Group

LLC, Kochinyan

13/16, Yerevan,

Republic of

Armenia

30 Fluconazole-Zdorovye fluconazole capsules hard

50mg,

in blister (7/1x7/,

10/1x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013,

Kharkov,

Shevchenko str., 22

Ukraine J02AC01 1655303.04.2017

03.04.2022PoM

Pharmaceutical

Company

"Zdorovye" LLC,

61013, Kharkov,

Shevchenko str., 22,

Ukraine

31 Fluconazole-Zdorovye fluconazole capsules hard

100mg,

in blister (7/1x7/,

10/1x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013,

Kharkov,

Shevchenko str., 22

Ukraine J02AC01 1655403.04.2017

03.04.2022PoM

Pharmaceutical

Company

"Zdorovye" LLC,

61013, Kharkov,

Shevchenko str., 22,

Ukraine

7

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32 Furosemide furosemide tablets

40mg,

in blister (50/5x10,

100/4x25/)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben-

batch releaser,

packager, Sandoz

Private Limited,

MIDC Plot No. 8-A/2

,8-B, T.T.C.

Industrial Area,

Kalwe Block, Village-

Digha, Opp. Thane-

Belapur Road,

Mumbai, 400 708,

India-bulk

manufacturer

Germany C03CA01 1656503.04.2017

03.04.2022PoM

Sandoz

Pharmaceuticals

d.d., Verovskova

Str. 57, 1000

Ljubljana, Slovenia

33 Furosemide furosemide tablets40mg,

in blister (50/5x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013,

Kharkov,

Shevchenko str., 22

Ukraine C03CA01 1662625.04.2017

25.04.2022PoM

Experimental Plant

"GNCLS" LLC,

61057, Kharkov,

Vorobyova str., 8,

Ukraine

34 Hartil Amloramipril, amlodipine

(amlodipine besilate)capsules

10mg+10mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659110.04.2017

10.04.2022PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

35 Hartil Amloramipril, amlodipine

(amlodipine besilate)capsules

5mg+10mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659210.04.2017

10.04.2022PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

36 Hartil Amloramipril, amlodipine

(amlodipine besilate)capsules

10mg+5mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659310.04.2017

10.04.2022PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

8

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37 Hartil Amloramipril, amlodipine

(amlodipine besilate)capsules

5mg+5mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659410.04.2017

10.04.2022PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

38 Hartil Amloramipril, amlodipine

(amlodipine besilate)capsules

2,5mg+2,5mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659510.04.2017

10.04.2022PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

39 Ketonal 50mg capsules ketoprofen capsules50mg,

glass container (25)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana

Slovenia M01AE03 14168/127.04.2017

24.12.2019PoM

Lek

Pharmaceuticals

d.d., Verovskova

Str. 57, 1526

Ljubljana, Slovenia

40Ketotifen Sopharma 1mg

tablets

ketotifen (ketotifen

hydrofumarate)tablets

1mg,

in blister (30/3x10/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria R06AX17 1664425.04.2017

25.04.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

41 Lisinocorlisinopril (lisinopril

dihydrate)tablets coated

5mg,

in blister (20/2x10/)

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi

Georgia C09AA03 1659610.04.2017

10.04.2022PoM

GM

Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi,

Georgia

42 Lisinocorlisinopril (lisinopril

dihydrate)tablets coated

10mg,

in blister (20/2x10/)

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi

Georgia C09AA03 1659710.04.2017

10.04.2022PoM

GM

Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi,

Georgia

9

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43 Loranex desloratadine solution oral

0,5mg/ml,

150ml glass vial and

measuring device

Laboratorios Basi-

Industria

Farmaceutica, S.A.,

Parque Industrial

Manuel Lourenco

Ferreira, lote 15,

3450-232 Mortagua

Portugal R06AX27 1663225.04.2017

25.04.2022OTC

GM

Pharmaceuticals

Ltd, 65,Phonichala

str., Tbilisi, Georgia

44 Loratadine loratadine tablets10mg,

in blister (10/1x10/)

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov", 64a No4,

ul. Chapaeva,

Borisov, Minsk

region

Belarus R06AX13 1662825.04.2017

25.04.2022OTC

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

45 Lucentis ranibizumabsolution for

injection

10mg/ml,

0.23ml glass vial

(1), syringe (1) and

needle (2)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland S01LA04 1659003.04.2017

03.04.2022PoM

Novartis Pharma

AG, 35,

Lichtstrasse, 4056

Basel, Switzerland

46 Lucetam piracetam film tablets coated1200mg,

glass container (20)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas kiraly st. 65

Hungary N06BX03 12564/225.04.2017

06.06.2018PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

47 Lucetam piracetam film-coated tablets800mg,

glass container (30)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas kiraly st. 65

Hungary N06BX03 12563/225.04.2017

06.06.2018PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

48 Naklofendiclofenac (diclofenac

sodium)suppositories rectal

50mg,

in strip (10/2x5/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia M01AB05 1662525.04.2017

25.04.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

10

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49 Natalsid sodium alginate suppositories rectal250mg,

(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia B02BC 1663725.04.2017

25.04.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-

459, Salganskaya st.,

7, Russia

50 Next ibuprofen, paracetamol tablets film-coated

400mg+200mg,

in blister (2/1x2/,

4/2x2/, 6/1x6/,

10/1x10/, 12/1x12/,

12/2x6/, 20/2x10/,

24/2x12/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia N02B 1662725.04.2017

25.04.2022OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

51 Noofen

gamma-amino-beta-

phenylbutyric acid

hydrochloride

powder for oral

solution

500mg,

2.5g sachet (5)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06BX22 1657503.04.2017

03.04.2022PoM

Olainfarm JSC, 5

Rupnicu Str.,

Olaine, LV-2114,

Latvia

52 Novocain-Zdorovyeprocaine (procaine

hydrochloride)

solution for

injection

5mg/ml,

2ml ampoules (10),

2ml ampoules, in

blister (5/1x5/,

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

5ml ampoules (10),

5ml ampoules, in

blister (5/1x5/,

10/2x5/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013,

Kharkov,

Shevchenko str., 22

Ukraine N01BA02 1662125.04.2017

25.04.2022PoM

Pharmaceutical

Company

"Zdorovye" LLC,

61013, Kharkov,

Shevchenko str., 22,

Ukraine

53 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/UC4

L.Molteni & C. Dei

F.lli Alitti Societa di

Esercizio S.p.A, S. S.

67, Localita

Granatieri,

Scandicci, 50018,

Italy

11

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54 Otofarifamycin (rifamycin

sodium)drops ear

26mg (20000IU)/ml,

10ml glass bottle

with dropper

Laboratoires

Bouchara-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

55 Parlazincetirizine (cetirizine

dihydrochloride)film-coated tablets

10mg,

in blister (10/1x10/,

30/3x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary R06AE07 15292/125.04.2017

04.02.2021OTC

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

56 Parlazincetirizine (cetirizine

dihydrochloride)film-coated tablets

10mg,

in blister (10/1x10/,

30/3x10/)

Egis Pharmaceuticals

PLC 9900, Kormend,

Matyas kiraly u. 65-

batch releaser,

packager, Egis

Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120-bulk

manufacturer

Hungary R06AE07 15293/125.04.2017

04.02.2021OTC

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

12

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57 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,

0165 Tbilisi,

Georgia

58 Polydexa

neomycin (neomycin

sulfate), polymyxin B

(polymyxin B sulfate),

dexamethasone

(dexamethasone sodium

metasulfobenzoate)

drops ear

1g

(650000U)/100ml+1

000000U/100ml+0,1

g/100ml,

10,5ml bottle-

dropper

Laboratoires

Bouchara-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

59 PROGEPTINornithine (ornithine

aspartate)

concentrate for

solution for

infusion

500mg/ml,

10ml ampoules

(10/2x5/)

"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

60 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

13

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61 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

62 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-Strasse 84,

4052 Basel,

Switzerland

63 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

Rupnicu Str.,

Olaine, LV-2114,

Latvia

64 Revoladeeltrombopag

(eltrombopag olamine)tablets film-coated

25mg,

in blister (28/4x7/)

Glaxo Wellcome

S.A., 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, Lichtstrasse 35,

4056 Basel,

Switzerland

65 Rixubis

nonacog gamma (human

blood coagulation factor

IX)

powder and solvent

for solution for

injection

500IU,

glass vial with

powder (1), 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

14

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66 Rixubis

nonacog gamma (human

blood coagulation factor

IX)

powder and solvent

for solution for

injection

250IU,

glass vial with

powder (1), 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 for

Baxalta Innovations

GmbH,

Industriestrasse 67, A-

1221 Vienna, Austria

Belgium B02BD04 1663025.04.2017

25.04.2022PoM

67 Rixubis

nonacog gamma (human

blood coagulation factor

IX)

powder and solvent

for solution for

injection

1000IU,

glass vial with

powder (1), 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 1663125.04.2017

25.04.2022PoM

Baxalta Innovations

GmbH,

Industriestrasse 67,

A-1221 Vienna,

Austria

68 Rocephinceftriaxone (ceftriaxone

sodium)

powder for solution

for injection

1000mg,

glass vial

(143/1x143/)

F.Hoffmann-La

Roche Ltd.

Wurmisweg, CH-

4303 Kaiseraugst

Switzerland J01DD04 1664025.04.2017

25.04.2022PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124 Basel, CH-4070,

Switzerland

69 Sandostatinoctreotide (octreotide

acetate)

solution for

injection

0,05mg/ml,

1ml ampoules (5)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland H01CB02 1661512.04.2017

12.04.2022PoM

Novartis Pharma

AG, 35,

Lichtstrasse, 4056

Basel, Switzerland

15

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70 Sandostatinoctreotide (octreotide

acetate)

solution for

injection

0,1mg/ml,

1ml ampoules (5)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland H01CB02 1661612.04.2017

12.04.2022PoM

Novartis Pharma

AG, 35,

Lichtstrasse, 4056

Basel, Switzerland

71 Senadexin-Zdorovye sennosides A, B tablets

70mg,

in blister (10,

20/2x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013,

Kharkov,

Shevchenko str., 22

UkraineA06AB06;

herbal drug16617

25.04.2017

25.04.2022OTC

Pharmaceutical

Company

"Zdorovye" LLC,

61013, Kharkov,

Shevchenko str., 22,

Ukraine

72 Septolete menthol benzalkonium chloride lozenges1mg,

in blister (30/2x15/)

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 1654203.04.2017

03.04.2022OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

73 Sirdaludtizanidine (tizanidine

hydrochloride)tablets

2mg,

in blister (30/3x10/)

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, 35,

Lichtstrasse, 4056

Basel, Switzerland

74 Sirdaludtizanidine (tizanidine

hydrochloride)tablets

4mg,

in blister (30/3x10/)

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 1658303.04.2017

03.04.2022PoM

Novartis Pharma

AG, 35,

Lichtstrasse, 4056

Basel, Switzerland

16

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75 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+

126,3mg+0,9mg+75

mcg+8mg+ 55mcg,

in plastic container

(30, 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-Strasse 84,

4052 Basel,

Switzerland

76 Tavintenofovir disoproxil

fumaratetablets film-coated

300mg,

in plastic container

(30)

Emcure

Pharmaceuticals Ltd.,

Lane No. 3, Phase II,

SIDCO Industrial

Complex, Bari-

Brahmana, Jammu

(J&K)-181 133

India J05AF07 1662225.04.2017

25.04.2022PoM

Emcure

Pharmaceuticals

Ltd., T-184,

M.I.D.C., Bhosari,

Pune-411026, India

77 Tegretol carbamazepine tablets200mg,

in blister (50/5x10/)

Novartis Farma

S.p.A., Via

Provinciale Schito

131, 80058 Torre

Annunziata (NA)

Italy N03AF01 1658103.04.2017

03.04.2022PoM

Novartis Pharma

AG, Lichtstrasse 35,

4056 Basel,

Switzerland

78 Teotard theophyllinecapsules modified-

release

200mg,

in blister (40/4x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

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

17

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79 Teotard theophyllinecapsules modified-

release

350mg,

in blister (40/4x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

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

80 Teqsatron

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for i/m and

i/v injection

8mg/4ml,

4ml ampoules (5,

10)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,

village Belikovo,

rural settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia A04AA01 1657603.04.2017

03.04.2022PoM

"Sotex"PharmFirm"

CJSC, Bld. 11,

village Belikovo,

rural settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

81 Teqsatron

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for i/m and

i/v injection

4mg/2ml,

2ml ampoules (5,

10)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,

village Belikovo,

rural settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia A04AA01 1657703.04.2017

03.04.2022PoM

"Sotex"PharmFirm"

CJSC, Bld. 11,

village Belikovo,

rural settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

82 Theraflex Advance

glucosamine

(glucosamine sulfate),

chondroitin sulfate

(chondroitin sulfate

sodium), ibuprofen

capsules

250mg+200mg+

100mg,

in plastic container

(60, 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-Strasse 84,

4052 Basel,

Switzerland

18

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83 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

Health S.A., Route

de I`Etraz, Case

postale 269, 1260

Nyon, Switzerland

84 Tramadoltramadol (tramadol

hydrochloride)capsules

50mg,

in blister (20/2x10/)

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

85 Tramadoltramadol (tramadol

hydrochloride)

solution for

injection

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

86 Triphthazin-Zdorovye

trifluoperazine

(trifluoperazine

hydrochloride)

tablets film-coated

5mg,

in blister (50/1x50/,

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

in blister (50/1x50/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013,

Kharkov,

Shevchenko str., 22

Ukraine N05AB06 1656703.04.2017

03.04.2022PoM/UC

Pharmaceutical

Company

"Zdorovye" LLC,

61013, Kharkov,

Shevchenko str., 22,

Ukraine

87

TROGE

PARACETAMOL 500mg

tablets

paracetamol tablets

500mg,

in blister

(1000/100x10/)

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

88 TRO-VIAGILE 100mgsildenafil (sildenafil

citrate)tablets film-coated

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

19

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89 Troxevasin 2% troxerutin gel for external use

20mg/g,

40g aluminium or

plastic 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

90 Valerian extract valerian thick extract tablets coated

20mg,

in blister (50/5x10/,

50/2x25/), in glass

container (50), in

blisters (500/10/),

in blisters (300/25/),

glass container

(110/50/)

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

BelarusN05CM09;

herbal drug16563

03.04.2017

03.04.2022OTC

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

91 Voltarendiclofenac (diclofenac

sodium)suppositories

25mg,

in blister (10/2x5/)

Delpharm Huningue

S.A.S., 26 rue de la

Chapelle, 68330

Huningue

France M01AB05 1658403.04.2017

03.04.2022PoM

Novartis Pharma

AG, Lichtstrasse 35,

4056 Basel,

Switzerland

92 Voltarendiclofenac (diclofenac

sodium)suppositories

100mg,

in blister (5)

Delpharm Huningue

S.A.S., 26 rue de la

Chapelle, 68330

Huningue

France M01AB05 1658503.04.2017

03.04.2022PoM

Novartis Pharma

AG, Lichtstrasse 35,

4056 Basel,

Switzerland

93 Voltarendiclofenac (diclofenac

sodium)suppositories

50mg,

in blister (10/2x5/)

Delpharm Huningue

S.A.S., 26 rue de la

Chapelle, 68330

Huningue

France M01AB05 1658603.04.2017

03.04.2022PoM

Novartis Pharma

AG, Lichtstrasse 35,

4056 Basel,

Switzerland

94 Voltaren Rapiddiclofenac (diclofenac

potassium)tablets sugar-coated

50mg,

in blister (20/2x10/)

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 M01AB05 1658703.04.2017

03.04.2022PoM

Novartis Pharma

AG, 35,

Lichtstrasse, 4056

Basel, Switzerland

20

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95 Voltaren Rapiddiclofenac (diclofenac

potassium)tablets sugar-coated

25mg,

in blister (30/3x10/)

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 M01AB05 1658803.04.2017

03.04.2022PoM

Novartis Pharma

AG, 35,

Lichtstrasse, 4056

Basel, Switzerland

96 Voltaren Retarddiclofenac (diclofenac

sodium)

tablets prolonged-

release

75mg,

in blister (20/2x10/)

Novartis Farma

S.p.A., Via

Provinciale Schito

131, 80058 Torre

Annunziata (NA)

Italy M01AB05 1658903.04.2017

03.04.2022PoM

Novartis Pharma

AG, Lichtstrasse 35,

4056 Basel,

Switzerland

97 Votrient pazopanib tablets film-coated

400mg,

in plastic container

(30)

Glaxo Wellcome

S.A., 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 L01XE11 1656603.04.2017

03.04.2022PoM

Novartis Pharma

AG, Lichtstrasse 35,

4056 Basel,

Switzerland

98 Vurdondiclofenac (diclofenac

diethylammonium)gel for external use

10mg/g,

25g aluminium

tube

Help S.A., Pedini

Ioanninon, Ioannina,

45500

Greece M02AA15 15767/225.04.2017

07.04.2021OTC

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece

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

21