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)
Date: 2006-01-27
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

C 20/2

EN

Official Journal of the European Union

27.1.2006

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
Engelenkampstraat
Sittard, Nederland

International BV,
JJ

6131

72,

23.12.2005

Aptivus

23.12.2005

Avastin

23.12.2005

Stocrin

23.12.2005

Zometa

23.12.2005

Sustiva

23.12.2005

Rilutek

23.12.2005

Revasc

23.12.2005

Invirase

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

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

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

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

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

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

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

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

EU/1/04/272/001-002

28.12.2005

EU/1/05/315/001

28.12.2005

EU/1/04/300/001-002

3.1.2006

EU/1/99/111/001-009

3.1.2006

EU/1/01/176/001-006

3.1.2006

EU/1/99/110/001-009

3.1.2006

EU/1/96/010/001

28.12.2005

EU/1/97/043/001-003

3.1.2006

EU/1/96/026/001-002

3.1.2006

23.12.2005

Regranex

Janssen-Cilag International NV, Turn-
houtseweg 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

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

27.1.2006

EN

Official Journal of the European Union

C 20/3

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

BeneFIX

23.12.2005

Fortovase

23.12.2005

Truvada

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

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

Sciences

Gilead
Limited, Granta
CB1
Cambridge
Kingdom

International
Park Abington
United

6GT,

EU/1/97/047/001-003

28.12.2005

EU/1/98/075/001-002

3.1.2006

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