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Document 52008XC0725(04)

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )

OJ C 188, 25.7.2008, p. 16–22 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

25.7.2008   

EN

Official Journal of the European Union

C 188/16

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 2008

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council  (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council  (2) )

(2008/C 188/05)

—   Issuing, maintenance or modification of a national marketing authorisation

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

17.6.2008

Yasminelle

See Annex I

See Annex I

19.6.2008

17.6.2008

Belanette

See Annex II

See Annex II

19.6.2008

(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 FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State

Marketing autorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Bayer Austria GmbH

(Schering Austria GmbH)

Herbststr. 6-10

A-1160 Wien

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Belgium

Bayer S.A./N.V.

Avenue Louise 143

B-1050 Brussel

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Cyprus

Bayer Hellas AG

18-20 Sorou Str

GR-15125 Amaroussion Athens

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Czech Republic

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Denmark

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Estonia

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Finland

Bayer Schering Pharma Oy

Pansiontie 47

FI-20210 Turku

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

France

Bayer Santé

13, rue Jean Jaurès

F-92807 Puteaux Cedex

Jasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Germany

Bayer Vital GmbH

D-51368 Leverkusen

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Greece

Bayer Hellas AG

18-20 Sorou Str

GR-15125 Amaroussion Athens

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Hungary

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Iceland

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Ireland

Bayer Ltd

The Atrium

Blackthorn Road

Dublin 18

Ireland

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Italy

Bayer S.p.A.

Viale Certosa, 130

I-20156 Milano

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Latvia

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Lithuania

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Luxembourg

Bayer S.A./N.V.

Avenue Louise 143

B-1050 Brussel

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Malta

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Netherlands

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

Nederland

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Norway

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Poland

Schering Polska Sp. z o.o.

ul. Migdałowa 4

PL-02-796 Warszawa

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Portugal

Berlex, Especialidades Farmacêuticas, Lda.

Rua da Quinta do Pinheiro, No. 5

P-2794-003 Carnaxide

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Slovakia

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Slovenia

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Spain

Química Farmacéutica Bayer, S.L.

Av. Baix Llobregat, 3-5

E-08970 Sant Joan Despí, Barcelona

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

Sweden

Bayer Schering Pharma AG

D-13342 Berlin

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

United Kingdom

Schering Health Care Ltd

The Brow

Burgess Hill

West Sussex

RH15 9NE

United Kindgom

Yasminelle

0,02 mg/3 mg

Film-coated tablets

Oral use

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State

Marketing autorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Bayer Austria GmbH

(Schering Austria GmbH)

Herbststr. 6-10

A-1160 Wien

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Belgium

Bayer S.A./N.V.

Avenue Louise 143

B-1050 Brussel

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Cyprus

Bayer Hellas AG

18-20 Sorou Str

GR-15125 Amaroussion Athens

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Czech Republic

Bayer Schering Pharma AG

D-13342 Berlin

Belanette

0,02 mg/3 mg

Film-coated tablets

Oral use

Denmark

Bayer Schering Pharma AG

D-13342 Berlin

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Estonia

Bayer Schering Pharma AG

D-13342 Berlin

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Finland

Bayer Schering Pharma Oy

Pansiontie 47

FI-20210 Turku

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

France

Bayer Santé

13, rue Jean Jaurès

F-92807 Puteaux Cedex

Belanette

0,02 mg/3 mg

Film-coated tablets

Oral use

Germany

Jenapharm GmbH & Co. KG

Otto-Schott-Str. 15

D-07745 Jena

aida

0,02 mg/3 mg

Film-coated tablets

Oral use

Greece

Bayer Hellas AG

18-20 Sorou Str

GR-15125 Amaroussion Athens

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Hungary

Bayer Schering Pharma AG

D-13342 Berlin

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Ireland

Bayer Ltd

The Atrium

Blackthorn Road

Dublin 18

Ireland

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Italy

Bayer S.p.A.

Viale Certosa, 130

I-20156 Milano

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Latvia

Bayer Schering Pharma AG

D-13342 Berlin

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Lithuania

Bayer Schering Pharma AG

D-13342 Berlin

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Luxembourg

Bayer S.A./N.V.

Avenue Louise 143

B-1050 Brussel

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Malta

Bayer Schering Pharma AG

D-13342 Berlin

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Netherlands

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

Nederland

Belanette

0,02 mg/3 mg

Film-coated tablets

Oral use

Norway

Bayer Schering Pharma AG

D-13342 Berlin

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Poland

Bayer Schering Pharma AG

D-13353 Berlin

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Portugal

Lusal, Produção Químico-Farmacêutica Luso-Alemã, Lda.

Estrada Nacional 249, Km 15

P-2725-397 Mem Martins

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Slovakia

Bayer Schering Pharma AG

D-13342 Berlin

Aliane

0,02 mg/3 mg

Film-coated tablets

Oral use

Slovenia

Bayer Schering Pharma AG

D-13342 Berlin

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Spain

Química Farmacéutica Bayer, S.L.

Av. Baix Llobregat, no 3-5

E-08970 Sant Joan Despí, Barcelona

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

Sweden

Bayer Schering Pharma AG

D-13342 Berlin

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use
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