# C_2014428EN.01000701.xml

| 28.11.2014 | EN | Official Journal of the European Union | C 428/7 |
| --- | --- | --- | --- |

28.11.2014

EN

Official Journal of the European Union

C 428/7

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2014 to 31 October 2014

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

1

2

(2014/C 428/02)

—   Issuing, maintenance or modification of a national marketing authorisation

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 30.10.2014 | Bromocriptine | See Annex I | See Annex I | See Annex I | 3.11.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

30.10.2014

Bromocriptine

See Annex I

See Annex I

See Annex I

3.11.2014

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(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

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ANNEX I

List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States

| Member State
  in EEA | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Meda Pharma GmbH
  Guglgasse 15/II. Stock 1110
  Wien
  Austria | Parlodel 2,5 mg — Tabletten | 2.5 mg | tablet | oral use |
| Belgium | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel | 2.5 mg | tablet | oral use |
| Belgium | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel 5 mg | 5 mg | capsule, hard | oral use |
| Belgium | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel 10 mg | 10 mg | capsule, hard | oral use |
| Bulgaria | Sopharma AD
  16 ‘Iliensko shose’ Str.
  Sofia 1220
  Bulgaria | Bromocriptine Sopharma | 2.5 mg | tablet | oral use |
| Bulgaria | Medochemie Ltd.
  1-10 Astronafton Str.
  Limassol 3505
  Cyprus | Medocriptine | 2.5 mg | tablet | oral use |
| Croatia | Sandoz d.o.o.
  Maksimirska 120/V
  Zagreb 10  000
  Croatia | Bromergon 2,5 mg tablete | 2.5 mg | tablet | oral use |
| Cyprus | Codal Synto Ltd
  33 Theklas Lysioti street Dorothea Building, 6th floor
  Lemesos 3508
  Cyprus | Pirodal | 2.5 mg | tablet | oral use |
| Cyprus | Remedica Ltd Aharnon Street
  Limassol Industrial Estate
  Lemesos 3508 Cyprus | Brameston | 2.5 mg | tablet | oral use |
| Cyprus | Medochemie Ltd Constantinoupoleos 1-10 Street
  Lemesos 3501 Cyprus | Medocriptine | 2.5 mg | tablet | oral use |
| Czech Republic | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  110 00 Prague 10
  Czech Republic | Parlodel | 2.5 mg | tablet | oral use |
| Czech Republic | Medochemie Ltd.
  Constantinoupoleos Str. 1-10
  3011 Limassol — Tsiflikoudia
  Cyprus | Medocriptine | 2.5 mg | tablet | oral use |
| Denmark | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 10 mg | capsule, hard | oral use |
| Denmark | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 5 mg | capsule, hard | oral use |
| Denmark | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 2.5 mg | tablet | oral use |
| Estonia | Gedeon Richter Plc.
  Gyömrõi ut 19-21
  1103 Budapest
  Hungary | BROMOCRIPTIN-RICHTER | 2.5 mg | tablet | oral use |
| Finland | Meda Oy
  Vaisalantie 4
  02130 Espoo
  Finland | PARLODEL | 2.5 mg | tablet | oral use |
| France | MEDA PHARMA
  25, boulevard de l'Amiral Bruix 75016 Paris
  France | PARLODEL 2,5 mg inhibition de la lactation | 2.5 mg | tablet | oral use |
| France | SANOFI AVENTIS FRANCE
  1-13 boulevard Romain Rolland
  75014 PARIS
  France | BROMOCRIPTINE ZENTIVA 2,5 mg lNHIBITION DE LA LACTATION | 2.5 mg | tablet | oral use |
| Germany | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Bromocriptin AbZ 2,5 mg | 2.5 mg | tablet | oral use |
| Germany | Betapharm Arzneimittel GmbH
  Kobelweg 95
  86156 Augsburg
  Germany | Bromocriptin beta 2,5 | 2.5 mg | tablet | oral use |
| Germany | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | bromocriptin-ct 2,5 mg Tabletten | 2.5 mg | tablet | oral use |
| Germany | Hexal AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Bromocriptin HEXAL 2,5 mg Tabletten | 2.5 mg | tablet | oral use |
| Germany | MEDA Pharma GmbH & Co. KG
  Benzstr. 1
  61352 Bad Homburg
  Germany | Pravidel 2,5 mg Tabletten | 2.5 mg | tablet | oral use |
| Germany | Ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Bromocriptin-ratiopharm 2,5 mg Tabletten | 2.5 mg | tablet | oral use |
| Greece | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 2.5 mg | tablet | oral use |
| Greece | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 5 mg | capsule, hard | oral use |
| Greece | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 10 mg | capsule, hard | oral use |
| Hungary | Gedeon Richter Plc
  Gyömrői út 19-21
  H-1103 Budapest
  Hungary | Bromocriptin-Richter 2,5 mg tabletta | 2.5 mg | tablet | oral use |
| Ireland | Meda Health Sales Ireland Limited
  Unit 34/35, Block A
  Dunboyne Business Park
  Dunboyne Co. Meath
  Ireland | Parlodel 2.5 mg Tablets | 2.5 mg | tablet | oral use |
| Ireland | Meda Health Sales Ireland Limited
  Unit 34/35, Block A
  Dunboyne Business Park
  Dunboyne Co. Meath
  Ireland | Parlodel 5 mg Hard Capsules | 5 mg | capsule, hard | oral use |
| Lithuania | Gedeon Richter Plc.
  Gyömröi út 19-21
  1103 Budapest
  Hungary | BROMOCRIPTIN-RICHTER | 2.5 mg | tablet | oral use |
| Luxembourg | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  61352 Bad Homburg
  Germany | Pravidel | 2.5 mg | tablet | oral use |
| Norway | Meda AS
  Askerveien 61
  Postboks 194
  1371 Asker
  Norway | Parlodel | 2.5 mg | tablet | oral use |
| Poland | Sandoz GmbH
  Biochemiestrasse 10
  Kundl
  6250 Tyrol
  Austria | Bromergon | 2.5 mg | tablet | oral use |
| Poland | Farmaceutyczna Spółdzielnia Pracy FILOFARM
  ul. Pułaskiego 39
  85-619 Bydgoszcz
  Poland | Bromocorn | 2.5 mg | tablet | oral use |
| Poland | Meda Aktiebolag
  Pipers vag 2
  170 09 Solana
  Box 906
  Sweden | Parlodel | 2.5 mg | tablet | oral use |
| Portugal | Meda Pharma — Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 5 mg | capsule | oral use |
| Portugal | Meda Pharma — Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 10 mg | capsule | oral use |
| Portugal | Meda Pharma — Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 2.5 mg | tablet | oral use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  Amadora, 2700-487
  Portugal | Bromocriptina Generis 2,5 mg comprimidos | 2.5 mg | tablet | oral use |
| Romania | S.C. BIOFARM S.A.
  Str. Logofăt Tăutu nr. 99
  sector 3, Bucureşti
  031212
  Romania | BROMOCRIPTIN | 2.5 mg | coated tablet | oral use |
| Slovak Republic | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  100 00 Praha 10
  Czech Republic | Parlodel | 2.5 mg | tablet | oral use |
| Slovak Republic | Medochemie Ltd.
  1-10 Constantinoupoleos St.
  3011 Limassol
  Cyprus | MEDOCRIPTINE 2,5 mg | 2.5 mg | tablet | oral use |
| Slovenia | Lek farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana Slovenia | Bromergon 2,5 mg tablete | 2.5 mg | tablet | oral use |
| Spain | MEDA PHARMA, S.A.U. Avda. Castilla 2,
  Edificio Berlín 2a planta
  Parque Empresarial San Fernando 28830 San Fernando de Henares (Madrid)
  Spain | Parlodel 2,5 mg comprimidos | 2.5 mg | tablet | oral use |
| Sweden | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 2.5 mg | tablet | oral use |
| Sweden | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 10 mg | capsule, hard | oral use |
| Sweden | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 5 mg | capsule, hard | oral use |
| The Netherlands | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 10 mg capsules | 10 mg | capsule, hard | oral use |
| The Netherlands | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 2,5 mg | 2.5 mg | tablet | oral use |
| The Netherlands | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 5 mg capsules | 5 mg | capsule, hard | oral use |
| United Kingdom | Teva UK Limited
  Brampton Road, Hampden Park Eastbourne, East Sussex
  BN22 9AG
  United Kingdom | Teva UK Bromocriptine Tablets | 2.5 mg | tablet | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road
  Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 1 mg Tablets | 1 mg | tablet | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House, Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 2.5 mg Tablets | 2.5 mg | tablet | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House, Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 5 mg Tablets | 5 mg | capsule | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 10 mg Tablets | 10 mg | capsule | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Bromocriptine 1 mg Tablets | 1 mg | tablet | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Bromocriptine 2.5 mg Tablets | 2.5 mg | tablet | oral use |

Member State

in EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Meda Pharma GmbH

Guglgasse 15/II. Stock 1110

Wien

Austria

Parlodel 2,5 mg — Tabletten

2.5 mg

tablet

oral use

Belgium

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel

2.5 mg

tablet

oral use

Belgium

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel 5 mg

5 mg

capsule, hard

oral use

Belgium

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel 10 mg

10 mg

capsule, hard

oral use

Bulgaria

Sopharma AD

16 ‘Iliensko shose’ Str.

Sofia 1220

Bulgaria

Bromocriptine Sopharma

2.5 mg

tablet

oral use

Bulgaria

Medochemie Ltd.

1-10 Astronafton Str.

Limassol 3505

Cyprus

Medocriptine

2.5 mg

tablet

oral use

Croatia

Sandoz d.o.o.

Maksimirska 120/V

Zagreb 10  000

Croatia

Bromergon 2,5 mg tablete

2.5 mg

tablet

oral use

Cyprus

Codal Synto Ltd

33 Theklas Lysioti street Dorothea Building, 6th floor

Lemesos 3508

Cyprus

Pirodal

2.5 mg

tablet

oral use

Cyprus

Remedica Ltd Aharnon Street

Limassol Industrial Estate

Lemesos 3508 Cyprus

Brameston

2.5 mg

tablet

oral use

Cyprus

Medochemie Ltd Constantinoupoleos 1-10 Street

Lemesos 3501 Cyprus

Medocriptine

2.5 mg

tablet

oral use

Czech Republic

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

Parlodel

2.5 mg

tablet

oral use

Czech Republic

Medochemie Ltd.

Constantinoupoleos Str. 1-10

3011 Limassol — Tsiflikoudia

Cyprus

Medocriptine

2.5 mg

tablet

oral use

Denmark

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

10 mg

capsule, hard

oral use

Denmark

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

5 mg

capsule, hard

oral use

Denmark

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

2.5 mg

tablet

oral use

Estonia

Gedeon Richter Plc.

Gyömrõi ut 19-21

1103 Budapest

Hungary

BROMOCRIPTIN-RICHTER

2.5 mg

tablet

oral use

Finland

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

PARLODEL

2.5 mg

tablet

oral use

France

MEDA PHARMA

25, boulevard de l'Amiral Bruix 75016 Paris

France

PARLODEL 2,5 mg inhibition de la lactation

2.5 mg

tablet

oral use

France

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 PARIS

France

BROMOCRIPTINE ZENTIVA 2,5 mg lNHIBITION DE LA LACTATION

2.5 mg

tablet

oral use

Germany

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Bromocriptin AbZ 2,5 mg

2.5 mg

tablet

oral use

Germany

Betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Bromocriptin beta 2,5

2.5 mg

tablet

oral use

Germany

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

bromocriptin-ct 2,5 mg Tabletten

2.5 mg

tablet

oral use

Germany

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Bromocriptin HEXAL 2,5 mg Tabletten

2.5 mg

tablet

oral use

Germany

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Pravidel 2,5 mg Tabletten

2.5 mg

tablet

oral use

Germany

Ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Bromocriptin-ratiopharm 2,5 mg Tabletten

2.5 mg

tablet

oral use

Greece

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

2.5 mg

tablet

oral use

Greece

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

5 mg

capsule, hard

oral use

Greece

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

10 mg

capsule, hard

oral use

Hungary

Gedeon Richter Plc

Gyömrői út 19-21

H-1103 Budapest

Hungary

Bromocriptin-Richter 2,5 mg tabletta

2.5 mg

tablet

oral use

Ireland

Meda Health Sales Ireland Limited

Unit 34/35, Block A

Dunboyne Business Park

Dunboyne Co. Meath

Ireland

Parlodel 2.5 mg Tablets

2.5 mg

tablet

oral use

Ireland

Meda Health Sales Ireland Limited

Unit 34/35, Block A

Dunboyne Business Park

Dunboyne Co. Meath

Ireland

Parlodel 5 mg Hard Capsules

5 mg

capsule, hard

oral use

Lithuania

Gedeon Richter Plc.

Gyömröi út 19-21

1103 Budapest

Hungary

BROMOCRIPTIN-RICHTER

2.5 mg

tablet

oral use

Luxembourg

MEDA Pharma GmbH & Co. KG

Benzstraße 1

61352 Bad Homburg

Germany

Pravidel

2.5 mg

tablet

oral use

Norway

Meda AS

Askerveien 61

Postboks 194

1371 Asker

Norway

Parlodel

2.5 mg

tablet

oral use

Poland

Sandoz GmbH

Biochemiestrasse 10

Kundl

6250 Tyrol

Austria

Bromergon

2.5 mg

tablet

oral use

Poland

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Bromocorn

2.5 mg

tablet

oral use

Poland

Meda Aktiebolag

Pipers vag 2

170 09 Solana

Box 906

Sweden

Parlodel

2.5 mg

tablet

oral use

Portugal

Meda Pharma — Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

5 mg

capsule

oral use

Portugal

Meda Pharma — Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

10 mg

capsule

oral use

Portugal

Meda Pharma — Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

2.5 mg

tablet

oral use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora, 2700-487

Portugal

Bromocriptina Generis 2,5 mg comprimidos

2.5 mg

tablet

oral use

Romania

S.C. BIOFARM S.A.

Str. Logofăt Tăutu nr. 99

sector 3, Bucureşti

031212

Romania

BROMOCRIPTIN

2.5 mg

coated tablet

oral use

Slovak Republic

MEDA Pharma s.r.o.

Kodaňská 1441/46

100 00 Praha 10

Czech Republic

Parlodel

2.5 mg

tablet

oral use

Slovak Republic

Medochemie Ltd.

1-10 Constantinoupoleos St.

3011 Limassol

Cyprus

MEDOCRIPTINE 2,5 mg

2.5 mg

tablet

oral use

Slovenia

Lek farmacevtska družba d.d. Verovškova 57

1526 Ljubljana Slovenia

Bromergon 2,5 mg tablete

2.5 mg

tablet

oral use

Spain

MEDA PHARMA, S.A.U. Avda. Castilla 2,

Edificio Berlín 2a planta

Parque Empresarial San Fernando 28830 San Fernando de Henares (Madrid)

Spain

Parlodel 2,5 mg comprimidos

2.5 mg

tablet

oral use

Sweden

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

2.5 mg

tablet

oral use

Sweden

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

10 mg

capsule, hard

oral use

Sweden

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

5 mg

capsule, hard

oral use

The Netherlands

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 10 mg capsules

10 mg

capsule, hard

oral use

The Netherlands

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 2,5 mg

2.5 mg

tablet

oral use

The Netherlands

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 5 mg capsules

5 mg

capsule, hard

oral use

United Kingdom

Teva UK Limited

Brampton Road, Hampden Park Eastbourne, East Sussex

BN22 9AG

United Kingdom

Teva UK Bromocriptine Tablets

2.5 mg

tablet

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House Parsonage Road

Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 1 mg Tablets

1 mg

tablet

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House, Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 2.5 mg Tablets

2.5 mg

tablet

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House, Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 5 mg Tablets

5 mg

capsule

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 10 mg Tablets

10 mg

capsule

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Bromocriptine 1 mg Tablets

1 mg

tablet

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Bromocriptine 2.5 mg Tablets

2.5 mg

tablet

oral use

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