Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-04-25
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 March 2008 to 31 March 2008

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

(2008/C 104/05)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

Date of the
decision

Name of the
medicinal product

INN
(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical Thera-
peutic Chemical Code)

Date of
notification

18.3.2008

Pradaxa

dabigatran etexilate mesilate

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

EU/1/08/442/001-008

Capsule, hard

B01AE07

20.3.2008

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

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C 104/8

EN

Official Journal of the European Union

25.4.2008

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004):

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

3.3.2008

Noxafil

3.3.2008

Posacozanole SP

3.3.2008

AVANDIA

3.3.2008

Avandamet

3.3.2008

Avaglim

3.3.2008

Avonex

5.3.2008

MIRCERA

SP Europe
Rue de Stalle, 73/Stallestraat, 73
B-1180 Bruxelles/B-1180 Brussel

SP Europe
Rue de Stalle, 73/Stallestraat, 73
B-1180 Bruxelles/B-1180 Brussel

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Biogen Idec Ltd, 5 Roxborough
Way
Foundation Park
Maidenhead
Berkshire SL6 3UD
United Kindgom

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

EU/1/05/320/001

5.3.2008

EU/1/05/321/001

5.3.2008

EU/1/00/137/002-018

5.3.2008

EU/1/03/258/001-022

5.3.2008

EU/1/06/349/001-010

5.3.2008

EU/1/97/033/002-004

5.3.2008

EU/1/07/400/001-016

7.3.2008

5.3.2008

Replagal

Shire Human Genetic Therapies AB
Rinkebyvägen 11B
S-182 36 Danderyd

EU/1/01/189/001-006

7.3.2008

5.3.2008

Cholestagel

Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
Nederland

EU/1/03/268/001-003

7.3.2008

11.3.2008

Helicobacter Test
INFAI

INFAI, Institut für biomedizinische
Analytik & NMR Imaging GmbH
Universitätsstrasse 142
D-44799 Bochum

EU/1/97/045/001-004

13.3.2008

17.3.2008

Vivanza

Bayer AG
D-51368 Leverkusen

EU/1/03/249/001-012

19.3.2008

17.3.2008

Visudyne

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

EU/1/00/140/001

19.3.2008

25.4.2008

EN

Official Journal of the European Union

C 104/9

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

17.3.2008

Cialis

17.3.2008

Levitra

17.3.2008

Mimpara

17.3.2008

Parareg

17.3.2008

Revatio

17.3.2008

Viagra

18.3.2008

Omnitrope

18.3.2008

Zavesca

18.3.2008

Hycamtin

18.3.2008

Kaletra

18.3.2008

Hepsera

18.3.2008

Revlimid

19.3.2008

Arixtra

Eli Lilly Nederland B.V.
Grootslag 1-5
3991 RA Houten
Nederland

Bayer AG
D-51368 Leverkusen

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Nederland

Dompé Biotec S.p.A.
Via San Martino, 12,
I-20122 Milano

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
United Kingdom

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

Actelion Registration Ltd
BSI Building 13th Floor
389 Chiswick High Road
London W4 4AL
United Kingdom

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Gilead Sciences International
Limited
Cambridge CB21 6GT
United Kingdom

Celgene Europe Limited
8 The Square
Stockley Park
Uxbridge
Middlesex UB11 1FW
United Kingdom

Glaxo Group Ltd
Greenford Road Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/02/237/001-008

19.3.2008

EU/1/03/248/001-012

19.3.2008

EU/1/04/292/001-012

19.3.2008

EU/1/04/293/001-012

19.3.2008

EU/1/05/318/001

19.3.2008

EU/1/98/077/002-004
EU/1/98/077/006-008
EU/1/98/077/010-015

19.3.2008

EU/1/06/332/001-009

20.3.2008

EU/1/02/238/001

20.3.2008

EU/1/96/027/006-007

20.3.2008

EU/1/01/172/006

20.3.2008

EU/1/03/251/001-002

20.3.2008

EU/1/07/391/001-004

20.3.2008

EU/1/02/206/001-020

26.3.2008

C 104/10

EN

Official Journal of the European Union

25.4.2008

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

27.3.2008

MicardisPlus

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

EU/1/02/213/017-023

31.3.2008

27.3.2008

Kinzalkomb

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/02/214/011-015

31.3.2008

27.3.2008

Tygacil

27.3.2008

Aptivus

27.3.2008

Norvir

27.3.2008

Lyrica

27.3.2008

Xeloda

27.3.2008

Optimark

31.3.2008

Neoclarityn

31.3.2008

Azomyr

31.3.2008

Xigris

31.3.2008

DuoTrav

EU/1/06/336/001

31.3.2008

EU/1/05/315/001

31.3.2008

EU/1/96/016/001
EU/1/96/016/003-004

31.3.2008

EU/1/04/279/001-043

31.3.2008

EU/1/00/163/001-002

31.3.2008

EU/1/07/398/001-014

31.3.2008

EU/1/00/161/001-067

2.4.2008

EU/1/00/157/001-067

2.4.2008

EU/1/02/225/001-002

2.4.2008

EU/1/06/338/001-003

2.4.2008

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

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
United Kingdom

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

Tyco Healthcare Deutschland GmbH
Gewerbepark 1
D-93333 Neustadt/Donau

Schering Plough Europe
Rue de Stalle, 73/Stallestraat, 73
B-1180 Bruxelles/B-1180 Brussel

Schering Plough Europe
Rue de Stalle, 73/Stallestraat, 73
B-1180 Bruxelles/B-1180 Brussel

Eli Lilly Nederland B.V.
Grootslag 1-5
3991 RA Houten
Nederland

Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom

31.3.2008

Optisulin

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/133/001-008

2.4.2008

25.4.2008

EN

Official Journal of the European Union

C 104/11

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

31.3.2008

Abilify

31.3.2008

Zonegran

31.3.2008

Aerius

31.3.2008

Tandemact

EU/1/04/276/001-036

2.4.2008

EU/1/04/307/001-013

2.4.2008

EU/1/00/160/001-069

2.4.2008

EU/1/06/366/017-022

2.4.2008

Otsuka Pharmaceutical Europe Ltd
Hunton House
Highbridge Business Park
Oxford Road
Uxbridge
Middlesex UB8 1HU
United Kingdom

Eisai Limited
3 Shortlands
London W6 8EE
United Kingdom

Schering Plough Europe
Rue de Stalle, 73/Stallestraat, 73
B-1180 Bruxelles/B-1180 Brussel

Takeda Global Research and Devel-
opment Centre (Europe) Ltd
Arundel Great Court
2 Arundel Street
London WC2R 3DA
United Kingdom

— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)

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

11.3.2008

Quixidar

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/02/207/001-020

13.3.2008

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004):

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

5.3.2008

SevoFlo

11.3.2008

Neocolipor

18.3.2008

Stronghold

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Merial
29 Avenue Tony Garnier
F-69007 Lyon

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
United Kingdom

EU/2/02/035/001-007

7.3.2008

EU/2/98/008/001-004

13.3.2008

EU/2/99/014/001-012

20.3.2008

Anyone wishing to consult the public assessment report on the medicinal products in question and the deci-
sions relating thereto is invited to contact:
The European Medicines Agency
7, Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom