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 or Article 38 of Directive 2001/82/EC)
Date: 2014-11-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014428EN.01000701.xml










28.11.2014   


EN


Official Journal of the European Union


C 428/7





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))
(2014/C 428/02)
—   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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


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