# C_2008188EN.01001601.xml

| 25.7.2008 | EN | Official Journal of the European Union | C 188/16 |
| --- | --- | --- | --- |

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)
  )

(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 |

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.

1

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

2

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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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

Bayer Schering Pharma AG

D-13342 Berlin

Liofora

0,02 mg/3 mg

Film-coated tablets

Oral use

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