# C_2006020EN.01000201.xml

| 27.1.2006 | EN | Official Journal of the European Union | C 20/2 |
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27.1.2006

EN

Official Journal of the European Union

C 20/2

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2005 to 31 December 2005

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1

(2006/C 20/02)

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 23.12.2005 | Kinzalkomb | Bayer AG, D-51368 Leverkusen | EU/1/02/214/001-010 | 29.12.2005 |
| 23.12.2005 | PhotoBarr | Axcan Pharma International BV, Engelenkampstraat 72, 6131 JJ Sittard, Nederland | EU/1/04/272/001-002 | 28.12.2005 |
| 23.12.2005 | Aptivus | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein | EU/1/05/315/001 | 28.12.2005 |
| 23.12.2005 | Avastin | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300/001-002 | 3.1.2006 |
| 23.12.2005 | Stocrin | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/111/001-009 | 3.1.2006 |
| 23.12.2005 | Zometa | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/176/001-006 | 3.1.2006 |
| 23.12.2005 | Sustiva | Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UD8 1DH, United Kingdom | EU/1/99/110/001-009 | 3.1.2006 |
| 23.12.2005 | Rilutek | Aventis Pharma SA, 20 Avenue Raymond Aron, F-Antony Cedex 92165 | EU/1/96/010/001 | 28.12.2005 |
| 23.12.2005 | Revasc | Canyon Pharmaceuticals Ltd, 20-22 Bedford Row, WC1R 4JS London, United Kingdom | EU/1/97/043/001-003 | 3.1.2006 |
| 23.12.2005 | Invirase | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026/001-002 | 3.1.2006 |
| 23.12.2005 | Regranex | Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse | EU/1/99/101/001 | 2.1.2006 |
| 23.12.2005 | MicardisPlus | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein | EU/1/02/213/001-010 | 5.1.2006 |
| 23.12.2005 | BeneFIX | Wyeth Europa Ltd, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-003 | 28.12.2005 |
| 23.12.2005 | Fortovase | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/075/001-002 | 3.1.2006 |
| 23.12.2005 | Truvada | Gilead Sciences International Limited, Granta Park Abington Cambridge CB1 6GT, United Kingdom | EU/1/04/305/001 | 3.1.2006 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

23.12.2005

Kinzalkomb

Bayer AG, D-51368 Leverkusen

EU/1/02/214/001-010

29.12.2005

23.12.2005

PhotoBarr

Axcan Pharma International BV, Engelenkampstraat 72, 6131 JJ Sittard, Nederland

EU/1/04/272/001-002

28.12.2005

23.12.2005

Aptivus

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein

EU/1/05/315/001

28.12.2005

23.12.2005

Avastin

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

3.1.2006

23.12.2005

Stocrin

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/99/111/001-009

3.1.2006

23.12.2005

Zometa

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/176/001-006

3.1.2006

23.12.2005

Sustiva

Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UD8 1DH, United Kingdom

EU/1/99/110/001-009

3.1.2006

23.12.2005

Rilutek

Aventis Pharma SA, 20 Avenue Raymond Aron, F-Antony Cedex 92165

EU/1/96/010/001

28.12.2005

23.12.2005

Revasc

Canyon Pharmaceuticals Ltd, 20-22 Bedford Row, WC1R 4JS London, United Kingdom

EU/1/97/043/001-003

3.1.2006

23.12.2005

Invirase

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/026/001-002

3.1.2006

23.12.2005

Regranex

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse

EU/1/99/101/001

2.1.2006

23.12.2005

MicardisPlus

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein

EU/1/02/213/001-010

5.1.2006

23.12.2005

BeneFIX

Wyeth Europa Ltd, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-003

28.12.2005

23.12.2005

Fortovase

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/98/075/001-002

3.1.2006

23.12.2005

Truvada

Gilead Sciences International Limited, Granta Park Abington Cambridge CB1 6GT, United Kingdom

EU/1/04/305/001

3.1.2006

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 23.12.2005 | Zubrin | Schering-Plough Limited, Schering-Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom | EU/2/00/028/001-008 | 28.12.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

23.12.2005

Zubrin

Schering-Plough Limited, Schering-Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom

EU/2/00/028/001-008

28.12.2005

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| London E14 4HB |
| United Kingdom |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

London E14 4HB

United Kingdom

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(1)  OJ L 136, 30.4.2004, p. 1.

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