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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 Amlo-Denk 10 amlodipine (amlodipine mesilate monohydrate) tablets 10mg, in blister (50/5x10/) Denk Pharma GmbH & Co. KG, Goellstr. 1, 84529 Tittmoning Germany C08CA01 16132 10.11.2016 10.11.2021 PoM 2 Denk Pharma GmbH & Co. KG, Prinzregentenstr. 79, 81675 Munchen, Germany 2 Amlo-Denk 5 amlodipine (amlodipine mesilate monohydrate) tablets 5mg, in blister (50/5x10/) Denk Pharma GmbH & Co. KG, Goellstr. 1, 84529 Tittmoning Germany C08CA01 16133 10.11.2016 10.11.2021 PoM Denk Pharma GmbH & Co. KG, Prinzregentenstr. 79, 81675 Munchen, Germany 3 Amlonor amlodipine (amlodipine besilate) tablets 10mg, in blister (30/3x10/) Pharmaceutical Works Polfa in Pabianice JSC, 5 Marszalka J. Pilsudskiego Str., 95- 200 Pabianice Poland C08CA01 16150 23.11.2016 23.11.2021 PoM Pharmaceutical Works Polfa in Pabianice JSC, 5 Marszalka J. Pilsudskiego Str., 95- 200 Pabianice, Poland 4 Amlonor amlodipine (amlodipine besilate) tablets 5mg, in blister (30/3x10/) Pharmaceutical Works Polfa in Pabianice JSC, 5 Marszalka J. Pilsudskiego Str., 95- 200 Pabianice Poland C08CA01 16151 23.11.2016 23.11.2021 PoM Pharmaceutical Works Polfa in Pabianice JSC, 5 Marszalka J. Pilsudskiego Str., 95- 200 Pabianice, Poland LIST OF REGISTRED DRUGS IN ARMENIA (01.11.2016-30.11.2016) 1
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LIST OF REGISTRED DRUGS IN ARMENIA (01.11.2016 ... - · PDF filebenzylpenicillin, benzylpenicillin procaine powder for i/m ... Seoul, Korea South 14 Cefrobactum cefoperazone (cefoperazone

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Page 1: LIST OF REGISTRED DRUGS IN ARMENIA (01.11.2016 ... - · PDF filebenzylpenicillin, benzylpenicillin procaine powder for i/m ... Seoul, Korea South 14 Cefrobactum cefoperazone (cefoperazone

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 Amlo-Denk 10amlodipine (amlodipine

mesilate monohydrate)tablets

10mg,

in blister (50/5x10/)

Denk Pharma GmbH

& Co. KG, Goellstr.

1, 84529 Tittmoning

Germany C08CA01 1613210.11.2016

10.11.2021PoM2

Denk Pharma

GmbH & Co. KG,

Prinzregentenstr.

79, 81675

Munchen,

Germany

2 Amlo-Denk 5amlodipine (amlodipine

mesilate monohydrate)tablets

5mg,

in blister (50/5x10/)

Denk Pharma GmbH

& Co. KG, Goellstr.

1, 84529 Tittmoning

Germany C08CA01 1613310.11.2016

10.11.2021PoM

Denk Pharma

GmbH & Co. KG,

Prinzregentenstr.

79, 81675

Munchen,

Germany

3 Amlonoramlodipine (amlodipine

besilate)tablets

10mg,

in blister (30/3x10/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

Poland C08CA01 1615023.11.2016

23.11.2021PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice,

Poland

4 Amlonoramlodipine (amlodipine

besilate)tablets

5mg,

in blister (30/3x10/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

Poland C08CA01 1615123.11.2016

23.11.2021PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice,

Poland

LIST OF REGISTRED DRUGS IN ARMENIA

(01.11.2016-30.11.2016)

1

Page 2: LIST OF REGISTRED DRUGS IN ARMENIA (01.11.2016 ... - · PDF filebenzylpenicillin, benzylpenicillin procaine powder for i/m ... Seoul, Korea South 14 Cefrobactum cefoperazone (cefoperazone

5 Amoxicillin amoxicillingranules for oral

suspension

250mg/5ml,

40g granules in

100ml glass bottle

and measuring

spoon 5ml

Hemofarm A.D.

26300, Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.,

Vrsac, 26224,

Dubovac, str. Cara

Lazara bb, Serbia-

bulk manufacturere,

packager

Serbia J01CA04 1617123.11.2016

23.11.2021PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

6 Antiflu

acetaminophen,

phenylephrine

(phenylephrine

hydrochloride),

chlorpheniramine

(chlorpheniramine

maleate)

tablets film-coated325mg+5mg+2mg,

in blister (12/1x12/)

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 N02BE51 1615323.11.2016

23.11.2021OTC3

Bayer Consumer

Care AG, Peter

Merian-Strasse 84,

4052 Basel,

Switzerland

7 Antiflu

acetaminophen,

phenylephrine

(phenylephrine

hydrochloride),

chlorpheniramine

(chlorpheniramine

maleate)

powder for oral

solution with

lemon flavour

650mg+10mg+4mg

sachets (5)

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 N02BE51 1615423.11.2016

23.11.2021OTC

for Bayer Consumer

Care AG, Peter

Merian-Strasse 84,

4052 Basel,

Switzerland

2

Page 3: LIST OF REGISTRED DRUGS IN ARMENIA (01.11.2016 ... - · PDF filebenzylpenicillin, benzylpenicillin procaine powder for i/m ... Seoul, Korea South 14 Cefrobactum cefoperazone (cefoperazone

8 Antiflu Kids

paracetamol, ascorbic

acid, chlorpheniramine

(chlorpheniramine

maleate)

powder for oral

solution with

raspberry flavour

160mg+50mg+ 1mg,

sachets (5)

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 N02BE51 1615523.11.2016

23.11.2021OTC

AO BAYER, 3rd

Rybinskaya St., 18,

build. 2, 107113

Moscow, Russia

9 Antimyk-Neu clotrimazole cream

10mg/g,

20g aluminium

tube

"NOKI" JV LTD Co.,

Nor-Kharberd,

Ararat region

Republic of

ArmeniaD01AC01 16142

10.11.2016

10.11.2021OTC

"NOKI" JV LTD

Co., Nor-Kharberd,

Ararat region,

Republic of

Armenia

10 Argosulfan sulfathiazole silvercream for external

use

20mg/g,

15g, 40g aluminium

tube,

400g plastic

container

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D06BA02 1611410.11.2016

10.11.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

11 Bicillin-3

benzathine

benzylpenicillin,

benzylpenicillin sodium,

benzylpenicillin

procaine

powder for i/m

suspension for

injection

200000IU+

200000IU+

200000IU,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J01CE30 1611610.11.2016

10.11.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo

street, 139, Ukraine

12 Bicillin-5

benzathine

benzylpenicillin,

benzylpenicillin

procaine

powder for i/m

suspension for

injection

1200000IU+

300000IU,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J01CE30 1611710.11.2016

10.11.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo

street, 139, Ukraine

3

Page 4: LIST OF REGISTRED DRUGS IN ARMENIA (01.11.2016 ... - · PDF filebenzylpenicillin, benzylpenicillin procaine powder for i/m ... Seoul, Korea South 14 Cefrobactum cefoperazone (cefoperazone

13 Cefepime-Asteria Inj. 1gcefepime (cefepime

hydrochloride)

powder for solution

for injection

1000mg,

glass vial (1, 10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea South J01DE01 1612610.11.2016

10.11.2021PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

14 Cefrobactum

cefoperazone

(cefoperazone sodium),

sulbactam (sulbactam

sodium)

powder for solution

for injection

1000mg+1000mg,

20ml glass vial (1)

Sanjivani Paranteral

Limited R-40, T.T.C.

Rabale, Thane-

Belapur Road, Navi

Mumbai 400 701

India J01DD62 1618823.11.2016

23.11.2021PoM

S.P. Incomed Pvt.

Ltd., H-680, Palam

Extn.-1, New Delhi

110 045, India

15 Chirocaine

levobupivacaine

(levobupivacaine

hydrochloride)

solution for

injection/infusion

5mg/ml,

10ml ampoules (10)

AbbVie S.r.l., S.R.

148 Pontina KM 52,

SNC - Campoverde

di Aprilia 04011

Aprilia (LT) -batch

releaser, secondary

packager, Curida AS,

Solbaervegen 5,

Elverum, NO-2409,

Norway- bulk

manufacturer,

primary packager

Italy N01BB10 1613710.11.2016

10.11.2021PoM

AbbVie

Biopharmaceuticals

GmbH,

Neuhofstrasse 23,

Postfach 6341 Baar,

Switzerland

16 Ciprinol ciprofloxacinsolution for

infusion

2mg/ml,

100ml glass vial

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01MA02 1612010.11.2016

10.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

17 Ciprinol

ciprofloxacin

(ciprofloxacin

hydrochloride

monohydrate)

tablets film-coated750mg,

in blister (10/1x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01MA02 1614623.11.2016

23.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

4

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18 Cipro-Denk 500

ciprofloxacin

(ciprofloxacin

hydrochloride)

tablets film-coated500mg,

in blister (10/1x10/)

Allphamed

PHARBIL

Arzneimittel GmbH,

Hildebrandstr. 12,

37081 Gottingen

Germany J01MA02 1613810.11.2016

10.11.2021PoM

Denk Pharma

GmbH & Co. KG,

Prinzregentenstr.

79, 81675

Muenchen,

Germany

19 Ciprofloxacin

ciprofloxacin

(ciprofloxacin

hydrochloride)

drops eye

3mg/ml,

10ml plastic vial-

dropper

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01AE03 16148

23.11.2016

23.11.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of

Armenia

20 Clostilbegytclomifene (clomifene

citrate)tablets

50mg,

in glass vial (10)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary G03GB02 1610310.11.2016

10.11.2021PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi ut 30-38,

Hungary

21Colchicine

Opocalciumcolchicine tablets

1mg,

in blister (20/1x20/)

S.C Zentiva S.A,

Theodor Pallady Blvd

nr. 50, sector 3,

Bucuresti, cod

032266

Romania M04AC01 1612910.11.2016

10.11.2021PoM

Laboratoires

MAYOLY

SPINDLER, 6

avenue de l`

Europe, 78400

Chatou, France

22 Co-Prenessaperindopril (perindopril

erbumine), indapamidetablets

4mg+1,25mg,

in blister (30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA04 1609110.11.2016

10.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

23 Co-Prenessaperindopril (perindopril

erbumine), indapamidetablets

2mg+0,625mg,

in blister (30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA04 1609210.11.2016

10.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

5

Page 6: LIST OF REGISTRED DRUGS IN ARMENIA (01.11.2016 ... - · PDF filebenzylpenicillin, benzylpenicillin procaine powder for i/m ... Seoul, Korea South 14 Cefrobactum cefoperazone (cefoperazone

24 Curosurf poractant alfasuspension

endotracheal

80mg/ml,

1.5ml glass vial

Chiesi

Pharmaceuticals

GmbH, Gonzagagasse

16/16, Wien, 1010-

batch releaser, Chiesi

Farmaceutici S.p.A,

Via Palermo 26/A-

43122 Parma(PR),

Italy-bulk

manufacturer,

primary packager,

G.L. Pharma GmbH,

Arnethgasse 3, 1160

Wien, Austria-

secondary packager

Austria R07AA02 1618223.11.2016

23.11.2021PoM

Chiesi

Pharmaceuticals

GmbH,

Gonzagagasse

16/16, Wien, 1010,

Austria

25 Dafneginciclopirox (ciclopirox

olamine)cream vaginal

10mg/g,

78g aluminium

tube and (14)

applicator

Doppel Farmaceutici

S.R.L., Via Martiri

delle Foibe, 1, 29016

Cortemaggiore (PC)

Italy G01AX12 1613010.11.2016

10.11.2021PoM

Polichem S.r.l., Via

G. Marcora, 11,

20121 Milan (MI),

Italy

26 Dafneginciclopirox (ciclopirox

olamine)

suppositories

vaginal

100mg,

(6/1x6/) and

applicator (6)

Doppel Farmaceutici

S.R.L., Via Martiri

delle Foibe, 1, 29016

Cortemaggiore (PC)

Italy G01AX12 1613110.11.2016

10.11.2021PoM

Polichem S.r.l., Via

G. Marcora, 11,

20121 Milan (MI),

Italy

27 Daivobet

betamethasone

(betamethasone

dipropionate),

calcipotriol (calcipotriol

monohydrate)

ointment for

external use

0,5mg/g+ 0,05mg/g,

15g, 30galuminium

or plastic tube

LEO Laboratories

Limited, 285 Cashel

Road, Dublin 12

Ireland D05AX52 12750/122.11.2016

06.08.2018OTC

LEO

Pharmaceutical

Products Ltd A/S

(LEO Pharma

A/S),Industriparken

55, DK-2750

Ballerup, Denmark

6

Page 7: LIST OF REGISTRED DRUGS IN ARMENIA (01.11.2016 ... - · PDF filebenzylpenicillin, benzylpenicillin procaine powder for i/m ... Seoul, Korea South 14 Cefrobactum cefoperazone (cefoperazone

28 Diclac gel 5%diclofenac (diclofenac

sodium)gel for external use

50mg/g,

50g aluminium

tube

Salutas Pharma

GmbH,

Betriebsstaette

Osterweddingen,

Lange Goehren

3,Suelzetal, OT

Osterweddingen,Sac

hsen-Anhalt, 39171

Germany M02AA15 1618323.11.2016

23.11.2021OTC

Sandoz

Pharmaceuticals

d.d., Verovskova

Str. 57, 1000

Ljubljana, Slovenia

29 Dorzopt

dorzolamide

(dorzolamide

hydrochloride)

drops eye

20mg/ml,

5ml plastic vial-

dropper

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A

Romania S01EC03 1611910.11.2016

10.11.2021PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str.

Eroilor, Nr. 1A,

Romania

30 Efloran metronidazolesolution for

infusion

5mg/ml,

100ml glass bottle

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01XD01 1609010.11.2016

10.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

31 Elonva corifollitropin alfasolution for

injection

150mcg/0,5ml,

0,5ml pre-filled

syringe and needle

(1)

Organon (Ireland)

Ltd., Drynam Road,

Swords, Co. Dublin -

batch releaser,

secondary packager,

Vetter Pharma-

Fertigung GmbH &

Co. KG,

Schutzenstrasse 87

and 99/101, D-88212

Ravensburg,

Germany-bulk

manufacturer,

primary packager

IrelandG03GA09;

new indication14120/1

23.11.2016

29.12.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

7

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32 Elonva corifollitropin alfasolution for

injection

100mg/0,5ml,

0,5ml pre-filled

syringeand needle

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)

IrelandG03GA09;

new indication14121/1

23.11.2016

29.12.2019PoM

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

33Esomeprazol SANDOZ

20mg

esomeprazole

(esomeprazole

magnesium dihydrate)

tablets gastro-

resistant

20mg,

in blister (14/2x7/,

28/4x7/)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany A02BC05 1619116.11.2016

16.11.2021PoM

Sandoz

Pharmaceuticals

d.d., Verovskova

Str. 57, 1000

Ljubljana, Slovenia

34Esomeprazol SANDOZ

40mg

esomeprazole

(esomeprazole

magnesium dihydrate)

tablets gastro-

resistant

40mg,

in blister (14/2x7/,

28/4x7/)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany A02BC05 1619016.11.2016

16.11.2021PoM

Sandoz

Pharmaceuticals

d.d., Verovskova

Str. 57, 1000

Ljubljana, Slovenia

35 Flumex fluconazole capsules hard150mg,

in blister (2)

ABC Farmaceutici

S.p.A, Via Cantone

Moretti, 29, 10090,

Ivrea

Italy J02AC01 1608610.11.2016

10.11.2021PoM

ABC Farmaceutici

S.p.A, Corso

Vittorio Emanuele

II, 72, Torino, Italy

36 Formetinmetformin (metformin

hydrochloride)tablets

500mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A10BA02 1608310.11.2016

10.11.2021PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd

str., 1a/18, Russia

8

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37 Formetinmetformin (metformin

hydrochloride)tablets

850mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A10BA02 1608410.11.2016

10.11.2021PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd

str., 1a/18, Russia

38 Formetinmetformin (metformin

hydrochloride)tablets

1000mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A10BA02 1608510.11.2016

10.11.2021PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd

str., 1a/18, Russia

39 Galvus vildagliptin tablets

50mg,

in blister (28/2x14/,

56/4x14/)

Novartis

Farmaceutica S.A.,

Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain A10BH02 1618723.11.2016

23.11.2021PoM

Novartis Pharma

AG, Lichtstrasse 35,

4056 Basel,

Switzerland

40 Ibuprofen Sandoz 600mg ibuprofen tablets film-coated600mg,

in blister (20/2x10/)

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-Kocaeli,

Turkey-bulk

manufacturer

Poland M01AE01 1610410.11.2016

10.11.2021PoM

Sandoz

Pharmaceuticals

d.d., Verovskova

Str. 57, 1526

Ljubljana, Slovenia

9

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41 Ibuprofen Sandoz 800mg ibuprofen tablets film-coated800mg,

in blister (20/2x10/)

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-Kocaeli,

Turkey-bulk

manufacturer

Poland M01AE01 1610510.11.2016

10.11.2021PoM

Sandoz

Pharmaceuticals

d.d., Verovskova

Str. 57, 1526

Ljubljana, Slovenia

42 Invega paliperidonetablets prolonged-

release

6mg,

in blister (28/4x7/)

Janssen-Cilag S.p.A.,

Via C. Janssen, 04100

Borgo San Michele,

Latina-batch releaser,

packager, Janssen

Cilag Manufacturing

LLC., State Road 933-

km 0.1, Mamey

Ward, Gurabo,

Puerto Rico 00778,

USA-bulk

manufacturer

Italy N05AX13 1618916.11.2016

16.11.2021PoM

Janssen- Cilag

International NV,

Turnhoutseweg 30,

B-2340 Beerse,

Belgium

43 Laticort

hydrocortisone

(hydrocortisone 17-n-

butyrate)

ointment for

external use

1mg/g,

15g aluminium

tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AB02 1611210.11.2016

10.11.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

44 Laticort

hydrocortisone

(hydrocortisone 17-n-

butyrate)

solution for

external use

1mg/ml,

20ml plastic vial

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AB02 1611310.11.2016

10.11.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

10

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45 Losar-Denk 100losartan (losartan

potassium)tablets film-coated

100mg,

in blister (28/2x14/)

Denk Pharma GmbH

& Co. KG, Goellstr.

1, 84529 Tittmoning

Germany C09CA01 1613910.11.2016

10.11.2021PoM

Denk Pharma

GmbH & Co. KG,

Prinzregentenstr.

79, 81675

Muenchen,

Germany

46 Losar-Denk 50losartan (losartan

potassium)tablets film-coated

50mg,

in blister (28/2x14/)

Denk Pharma GmbH

& Co. KG, Goellstr.

1, 84529 Tittmoning

Germany C09CA01 1614010.11.2016

10.11.2021PoM

Denk Pharma

GmbH & Co. KG,

Prinzregentenstr.

79, 81675

Muenchen,

Germany

47 Metoject

methotrexate

(methotrexate

disodium)

solution for

injection

10mg/ml,

0,75ml glass pre-

filled measuring

syringe, blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13162/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

48 Metoject

methotrexate

(methotrexate

disodium)

solution for

injection

10mg/ml,

1,5ml glass pre-

filled measuring

syringe, blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13164/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

11

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49 Metoject

methotrexate

(methotrexate

disodium)

solution for

injection

10mg/ml,

1ml glass pre-filled

measuring syringe,

blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13163/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

50 Metoject

methotrexate

(methotrexate

disodium)

solution for

injection

10mg/ml,

2,5ml glass pre-

filled measuring

syringe, blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13166/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

51 Metoject

methotrexate

(methotrexate

disodium)

solution for

injection

10mg/ml,

2ml glass pre-filled

measuring syringe,

blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13165/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

52 Metvix methyl aminolevulinatecream for external

use

160mg/g,

2g aluminium tube

Laboratoires

Galderma Z.I.

Montdesir, 74540

Alby-sur-Cheran

France L01XD03 1608910.11.2016

10.11.2021PoM

Galderma SA,

Zugerstrasse 8, CH-

6330 Cham,

Switzerland

12

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53 Mezym forte 10000pancreatin (lipase,

amylase, protease)

tablets gastro-

resistant

not less than

10000U+not less

than 7500U+not less

than 375U,

in blister (10/1x10/,

20/2x10/)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser,

Menarini-Von

Heyden GmbH,

Leipziger Strasse 7-

13, 01097 Dresden,

Germany-bulk

manufacturer,

packager

Germany A09AA02 1613610.11.2016

10.11.2021OTC

Berlin-Chemie

A.G.,Glienicker

Weg 125, D-12489

Berlin, Germany

54Mitoxantron Ebewe

2mg/ml

mitoxantrone

(mitoxantrone

hydrochloride)

concentrate for

solution for

infusion

2mg/ml,

10ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01DB07 1617423.11.2016

23.11.2021PoM

EBEWE Pharma

Ges. m.b.H. Nfg.

KG, Mondseestrasse

11, A-4866

Unterach am

Attersee, Austria

55Mitoxantron Ebewe

2mg/ml

mitoxantrone

(mitoxantrone

hydrochloride)

concentrate for

solution for

infusion

2mg/ml,

5ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01DB07 1617523.11.2016

23.11.2021PoM

EBEWE Pharma

Ges. m.b.H. Nfg.

KG, Mondseestrasse

11, A-4866

Unterach am

Attersee, Austria

56 Moditen depo

fluphenazine

(fluphenazine

decanoate)

solution for i/m

injection

25mg/ml,

1ml ampoules, in

blister (5/1x5/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia N05AB02 1616723.11.2016

23.11.2021PoM/UC4

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

57 Mythro 500

azithromycin

(azithromycin

dihydrate)

tablets film-coated500mg,

in blister (3/1x3/)

Akriti

Pharmaceuticals Pvt.

Ltd., Plot No. D-10,

D-11, M.I.D.C. Indl.

Estate, Nira Road,

Jejuri, Tal. Purandar

(Saswad), Dist. Pune-

412 303, Maharashtra

India J01FA10 1613510.11.2016

10.11.2021PoM

Akriti

Pharmaceuticals

Pvt. Ltd., 117,

Block No. 2,

Emerald Plaza,

Hiranandani

Meadows, Barrister

Nath Pai Road,

Thane (West) 400

610, India

13

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58 Naphthyzin-Arsanit naphazoline drops nasal

1mg/ml,

5ml and 10ml

plastic vial-dropper

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA08 16124

10.11.2016

10.11.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

59 Naphthyzin-Arsanit naphazoline drops nasal

0.5mg/ml,

5ml and 10ml

plastic vial-dropper

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA08 16125

10.11.2016

10.11.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

60 Nicoflex

capsaicin, ethyl

nicotinate,

ethylenglycol salicylate

ointment for

external use

0.15mg/g+20mg/g+9

0mg/g,

50g aluminium

tube

Reanal Private Co

Ltd., Telepes u. 54-

56., Budapest, 1147

Hungary M02A 1608710.11.2016

10.11.2021OTC

Medimpex Trading

Private Company

Limited, 1134

Budapest, Lehel

utca 11, Hungary

61 Nolpaza

pantoprazole

(pantoprazole sodium

sesquihydrate)

tablets gastro-

resistant

20mg,

in blister (14/1x14,

28/2x14/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A02BC02 15914/110.11.2016

23.08.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

62 Noofen

gamma-amino-beta-

phenylbutyric acid

hydrochloride

capsules250mg,

in blister (20/2x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06BX22 1617923.11.2016

23.11.2021PoM

Olainfarm JSC, 5

Rupnicu Str.,

Olaine, LV-2114,

Latvia

14

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63 Noofen

gamma-amino-beta-

phenylbutyric acid

hydrochloride

capsules500mg,

in blister (24/4x6/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06BX22 1618023.11.2016

23.11.2021PoM

Olainfarm JSC, 5

Rupnicu Str.,

Olaine, LV-2114,

Latvia

64 Octaplex

human blood

coagulation factor II,

human blood

coagulation factor VII,

human blood

coagulation factor IX,

human blood

coagulation factor X,

protein C, protein S

powder and solvent

for solution for

infusion

14-38IU/ml+9-

24IU/ml+25IU/ml+

18-30IU/ml+13-

31IU/ml+12-

32IU/ml,

glass vial with

powder (1), 20ml

glass vial with

solvent (1), transfer

set (1), disposable

syringe (1),

infusion set (1),

alcohol swabs (2)

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD01 1616923.11.2016

23.11.2021PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

65 Omeprazole omeprazole capsules20mg,

in blister (20/2x10/)

"NOKI" JV LTD Co.,

Nor-Kharberd,

Ararat region

Republic of

ArmeniaA02BC01 16143

10.11.2016

10.11.2021PoM

"NOKI" JV LTD

Co., Nor-Kharberd,

Ararat region,

Republic of

Armenia

66 Ostiralraloxifene (raloxifene

hydrochloride)tablets film-coated

60mg,

in blister (28/2x14/)

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

67 Paclitaxel paclitaxel

concentrate for

solution for

infusion

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

68 Paclitaxel paclitaxel

concentrate for

solution for

infusion

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

15

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69 Parietrabeprazole (rabeprazole

sodium)

tablets gastro-

resistant film-

coated

20mg,

blister (14/1x14/,

28/2x14/)

Cilag AG,

Schaffhausen CH-

8205, Hochstrasse

201

Switzerland A02BC04 12403/222.11.2016

19.04.2018PoM

Cilag AG,

Schaffhausen CH-

8205, Hochstrasse

201, Switzerland

70 Peritol

cyproheptadine

(cyproheptadine

hydrochloride)

tablets4mg,

in blister (20/2x10/)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary R06AX02 1610610.11.2016

10.11.2021PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi ut 30-38,

Hungary

71 Piracetam piracetamsolution for

injection

200mg/ml,

5ml ampoules,

in blister (10,

10/2x5/)

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus N06BX03 1608810.11.2016

10.11.2021PoM

Open joint stock

company

"Borisovskiy zavod

medicinskikh

preparatov" 64,

Chapaev str.,

Borisov 222518,

Minsk region

72 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-

myeon, Jincheon-

gun,

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

73 Prestilol 10mg/10mg

bisoprolol (bisoprolol

fumarate), perindopril

(perindopril arginine)

tablets film-coated

10mg+10mg,

in plastic container

(30)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C09BX02 1616123.11.2016

23.11.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

74 Prestilol 10mg/5mg

bisoprolol (bisoprolol

fumarate), perindopril

(perindopril arginine)

tablets film-coated

10mg+5mg,

in plastic container

(30)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C09BX02 1616223.11.2016

23.11.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

16

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75 Prestilol 5mg/10mg

bisoprolol (bisoprolol

fumarate), perindopril

(perindopril arginine)

tablets film-coated

5mg+10mg,

in plastic container

(30)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C09BX02 1616323.11.2016

23.11.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

76 Prestilol 5mg/5mg

bisoprolol (bisoprolol

fumarate), perindopril

(perindopril arginine)

tablets film-coated

5mg+5mg,

in plastic container

(30)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C09BX02 1616423.11.2016

23.11.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

77 Privigenhuman normal

immunoglobulin

solution 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

78 Privigenhuman normal

immunoglobulin

solution for

infusion

100mg/ml,

50ml glass vial

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22

Switzerland J06BA02 1610810.11.2016

10.11.2021PoM

CSL Behring AG,

Wankdorfstrasse

10, CH-3000 Bern

22, Switzerland

79 Privigenhuman normal

immunoglobulin

solution for

infusion

100mg/ml,

200ml glass vial

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22

Switzerland J06BA02 1610910.11.2016

10.11.2021PoM

CSL Behring AG,

Wankdorfstrasse

10, CH-3000 Bern

22, Switzerland

80 Privigenhuman normal

immunoglobulin

solution for

infusion

100mg/ml,

100ml glass vial

CSL Behring AG,

Wankdorfstrasse 10,

CH-3000 Bern 22

Switzerland J06BA02 1611010.11.2016

10.11.2021PoM

CSL Behring AG,

Wankdorfstrasse

10, CH-3000 Bern

22, Switzerland

81 Propafenon Alkaloid

propafenone

(propafenone

hydrochloride)

tablets film-coated150mg,

in blister (40/4x10/)

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

17

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82 Psoridermclobetasol (clobetasol

propionate)

solution for topical

use

0,5mg/ml,

25ml plastic

container

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

83 Rosartrosuvastatin

(rosuvastatin calcium)tablets film-coated

40mg,

in blister (28/2x14/,

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

84 Rosartrosuvastatin

(rosuvastatin calcium)tablets film-coated

10mg,

in blister (28/2x14/,

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

90/9x10/)

Actavis Ltd., BLB

015, BLB 016,

Bulebel Industrial

Estate, Zejtun, ZTN

3000

Malta C10AA07 1608110.11.2016

10.11.2021PoM

"Actavis Group

PTC ehf",

Reykjavikurvegur

76-78, IS-220

Hafnarfjordur,

Iceland

85 Rosartrosuvastatin

(rosuvastatin calcium)tablets film-coated

20mg,

in blister (28/2x14/,

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

90/9x10/)

Actavis Ltd., BLB

015, BLB 016,

Bulebel Industrial

Estate, Zejtun, ZTN

3000

Malta C10AA07 1608210.11.2016

10.11.2021PoM

"Actavis Group

PTC ehf",

Reykjavikurvegur

76-78, IS-220

Hafnarfjordur,

Iceland

86 Septolete D menthol benzalkonium chloride pastilles1mg,

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 1618423.11.2016

23.11.2021OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

18

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87 Sertazolsertaconazole

(sertaconazole nitrate)

suppositories

vaginal300mg; (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

88 Sinaflan fluocinolone acetonideointment for

external use

0,25mg/g,

10g aluminium

tube

Akrikhin

Pharmaceuticals Co.,

142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia D07AC04 1613410.11.2016

10.11.2021PoM

Akrikhin

Pharmaceuticals

Co., 142450,

Moscow region,

Noginsk district,

Staraya Kupavna,

Kirova street 29,

Russia

89 Solian amisulpridetablets scored film-

coated

400mg,

in blister (30/3x10/)

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

Rolland, 75014

Paris, France

90 Solian amisulpride tablets scored100mg,

in blister (30/3x10)

Sanofi Winthrop

Industrie, 6,

Boulevard de l

Europe 21800

Quetigny

France N05AL05 1617723.11.2016

23.11.2021PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain

Rolland, 75014

Paris, France

91 Solian amisulpride tablets scored200mg,

in blister (30/3x10/)

Sanofi Winthrop

Industrie, 6,

Boulevard de l

Europe 21800

Quetigny

France N05AL05 1617823.11.2016

23.11.2021PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain

Rolland, 75014

Paris, France

92 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

93 Sulfasalazin sulfasalazine tablets film-coated500mg,

in blister (50/5x10/)

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

19

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94 Sulfasalazin sulfasalazine tablets film-coated500mg,

in blister (50/5x10/)

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

95 Terbisilterbinafine (terbinafine

hydrochloride)tablets

250mg,

in blister (14/1x14/,

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

96 Terbisilterbinafine (terbinafine

hydrochloride)

cream for external

use

10mg/g,

15g aluminium

tube

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest

Hungary D01AE15 1616823.11.2016

23.11.2021OTC

Gedeon Richter

PLC, Gyomroi ut

19-21, 1103

Budapest

97 Tetracycline-Belmed

tetracycline

(tetracycline

hydrochloride)

tablets film-coated

100mg,

in blister (10/1x10/,

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

98 Thrombaspin acetylsalicylic acidtablets gastro-

resistant

100mg,

in blister (20/2x10/)

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

str., Tbilisi, Georgia

20

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99 Triumeq

dolutegravir

(dolutegravir sodium),

abacavir (abacavir

sulfate), lamivudine

tablets film-coated

50mg+600mg+

300mg,

in plastic container

(30)

Glaxo Wellcome

S.A., 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

100 Utrogestan progesterone capsules soft200mg,

in blister (14/2x7/)

Cyndea Pharma SL,

Poligono Industrial

Emiliano Revilla

Sanz, Avenida de

Agreda, 31, Olvega

42110(Soria)

Spain G03DA04 1615923.11.2016

23.11.2021PoM

Besins Healthcare

SA, Avenue Louise

287, 1050 Brussels,

Belgium

101 Utrogestan progesterone capsules soft100mg,

in blister (28/2x14/)

Cyndea Pharma SL,

Poligono Industrial

Emiliano Revilla

Sanz, Avenida de

Agreda, 31, Olvega

42110(Soria)

Spain G03DA04 1616023.11.2016

23.11.2021PoM

Besins Healthcare

SA, Avenue Louise

287, 1050 Brussels,

Belgium

102 Vinpocetine Covex 5mg vinpocetine tablets

5mg,

in blister, (25/1x25/,

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

21

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103 Virolex aciclovirpowder for solution

for infusion

250mg,

glass vial (5)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

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

104 Vitamin C ascorbic acid capsules500mg,

in blister (20/2x10/)

"NOKI" JV LTD Co.,

Nor-Kharberd,

Ararat region

Republic of

ArmeniaA11GA01 16141

10.11.2016

10.11.2021OTC

"NOKI" JV LTD

Co., Nor-Kharberd,

Ararat region,

Republic of

Armenia

105 Zalainsertaconazole

(sertaconazole nitrate)

suppositories

vaginal

300mg,

(1)

Trommsdorff GmbH

& Co. KG,

Arzneimittel,

Trommsdorffstrasse 2-

6, 52477, Alsdorf

Germany G01AF19 1615723.11.2016

23.11.2021PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

106 Zalainsertaconazole

(sertaconazole nitrate)

suppositories

vaginal

300mg,

(1)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

Trommsdorff GmbH

& Co. KG,

Arzneimittel,

Trommsdorffstrasse 2-

6, 52477, Alsdorf,

Germany- bulk

manufacturer,

packager

Hungary G01AF19 1615823.11.2016

23.11.2021PoM

Egis

Pharmaceuticals

PLC, 1106

Budapest,

Kereszturi st. 30-38,

Hungary

22

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107 Zimfil-ODF 10 tadalafil films orodispersible10mg,

sachets (4, 10)

Zim Laboratories

Ltd., B-21/22, MIDC

Area, Kalmeshwar-

441 501, Dist. Nagpur

(M.S.)

India G04BE08 1612710.11.2016

10.11.2021PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

108 Zimfil-ODF 20 tadalafil films orodispersible20mg,

sachets (4, 10)

Zim Laboratories

Ltd., B-21/22, MIDC

Area, Kalmeshwar-

441 501, Dist. Nagpur

(M.S.)

India G04BE08 1612810.11.2016

10.11.2021PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

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

23