This document is an excerpt from the EUR-Lex website
Document 52006XC0127(01)
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)
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)
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)
OJ C 20, 27.1.2006, p. 2–3
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
27.1.2006 |
EN |
Official Journal of the European Union |
C 20/2 |
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))
(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 |
— 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 |
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 |
(1) OJ L 136, 30.4.2004, p. 1.