# C_2005153EN.01000601.xml

| 24.6.2005 | EN | Official Journal of the European Union | C 153/6 |
| --- | --- | --- | --- |

24.6.2005

EN

Official Journal of the European Union

C 153/6

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 10 May 2005 to 15 June 2005

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

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1

2

(2005/C 153/04)

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 10.5.2005 | Regividon | See Annex | See Annex | 24.5.2005 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

10.5.2005

Regividon

See Annex

See Annex

24.5.2005

See Annex

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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

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

| Member State | Marketing authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Belgium | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Denmark | Medimpex France S.A. | | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Germany | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Greece | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Ireland | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Italy | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Luxembourg | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| The Netherlands | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Norway | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Portugal | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Spain | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| Sweden | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |
| United Kingdom | | Medimpex France S.A. | Rigevidon | 0,03 mg Ethinylestradiol
  0,150 mg Levonorgestrel | Coated tablets | Oral Use |

Member State

Marketing authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Belgium

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Denmark

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Germany

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Greece

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Ireland

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Italy

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Luxembourg

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

The Netherlands

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Norway

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Portugal

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Spain

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

Sweden

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

United Kingdom

Medimpex France S.A.

Rigevidon

0,03 mg Ethinylestradiol

0,150 mg Levonorgestrel

Coated tablets

Oral Use

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