Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2006-09-30
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical legislation

Summary of Community decisions on marketing authorizations in respect of medicinal
products from 1 August 2006 to 31 August 2006

(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 236/02)

— Issuing 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

INN
(International Non-Proprietary
Name)

Holder of the marketing
authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical Therapeutic
Chemical Code)

Date of
notification

10.8.2006

Thelin

sitaxentan sodium

28.8.2006

Exjade

deferasirox

Encysive (UK) Limited
Alder Castle House
10 Noble Street
London EC2V 7QJ
United Kingdom

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

EU/1/06/353/001-005

film coated tablet

Non applicable

11.8.2006

EU/1/06/356/001-006

Dispersible tablet

V03AC03

31.8.2006

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

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30.9.2006

EN

Official Journal of the European Union

C 236/3

— 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

4.8.2006

Taxotere

4.8.2006

NovoSeven

4.8.2006

Hepsera

4.8.2006

HBVAXPRO

Aventis Pharma S.A.
20 avenue Raymond Aron
F-92165 Antony Cedex

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Gilead Sciences International
Limited
Cambridge CB1 6GT
United Kingdom

Sanofi Pasteur MSD, SNC
8, rue Jonas Salk
F-69007 Lyon

4.8.2006

HBVAXPRO

Sanofi Pasteur MSD, SNC
8, rue Jonas Salk
F-69007 Lyon

EU/1/95/002/001-002

8.8.2006

EU/1/96/006/001-003

8.8.2006

EU/1/03/251/001

8.8.2006

8.8.2006

8.8.2006

EU/1/01/183/001
EU/1/01/183/004-005
EU/1/01/183/007-008
EU/1/01/183/011
EU/1/01/183/013
EU/1/01/183/015
EU/1/01/183/018-029

EU/1/01/183/001
EU/1/01/183/004-005
EU/1/01/183/007-008
EU/1/01/183/011
EU/1/01/183/013
EU/1/01/183/015
EU/1/01/183/018-029

EU/1/97/044/001-008

8.8.2006

EU/1/99/126/012

8.8.2006

4.8.2006

Tasmar

4.8.2006

Enbrel

4.8.2006

Mirapexin

4.8.2006

InductOs

7.8.2006

Levviax

7.8.2006

Ketek

Valeant Pharmaceuticals Limited
Cedarwood
Chineham Business Park
Crockford lane
Basingstoke RG24 8WD
United Kingdom

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

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

EU/1/97/051/001-006
EU/1/97/051009-012

8.8.2006

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

Aventis Pharma S.A.
20, Avenue Raymond Aron
F-92160 Antony

Aventis Pharma S.A.
20, Avenue Raymond Aron
F-92160 Antony

EU/1/02/226/001

8.8.2006

EU/1/01/192/001-005

9.8.2006

EU/1/01/191/001-005

9.8.2006

C 236/4

EN

Official Journal of the European Union

30.9.2006

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

7.8.2006

Lantus

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/001-029

9.8.2006

7.8.2006

Optisulin

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/133/001-008

9.8.2006

7.8.2006

Keppra

7.8.2006

Fasturtec

7.8.2006

Zenapax

UCB S.A.
Allée de la recherche, 60
B-1070 Bruxelles
Researchdreef 60
B-1070 Brussel

Sanofi-Aventis
174, avenue de France
F-75013 Paris

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

EU/1/00/146/001-030

9.8.2006

EU/1/00/170/001-002

9.8.2006

EU/1/99/098/001-002

9.8.2006

7.8.2006

KOGENATE Bayer

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/00/143/001-009

9.8.2006

7.8.2006

Xagrid

7.8.2006

Sifrol

7.8.2006

Optison

10.8.2006

Tracleer

10.8.2006

Rapilysin

21.8.2006

HBVAXPRO

Shire Pharmaceutical Contracts Ltd
Hampshire International Business
Park
Chineham
Basingstoke
Hampshire RG24 8EP
United Kingdom

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

Amersham Health AS
Nycoveien 1-2
P.O.Box 4220 Nydalen
N-0401 Oslo

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

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

Sanofi Pasteur MSD, SNC
8, rue Jonas Salk
F-69007 Lyon

EU/1/04/295/001

9.8.2006

EU/1/97/050/001-006
EU/1/97/050/009-012

9.8.2006

EU/1/98/065/001-002

9.8.2006

EU/1/02/220/001-005

14.8.2006

EU/1/96/018/001

14.8.206

23.8.2006

EU/1/01/183/001
EU/1/01/183/004-005
EU/1/01/183/007-008
EU/1/01/183/011
EU/1/01/183/013
EU/1/01/183/015
EU/1/01/183/018-029

30.9.2006

EN

Official Journal of the European Union

C 236/5

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

21.8.2006

Ziagen

21.8.2006

NovoSeven

28.8.2006

Bonviva

28.8.2006

Aptivus

28.8.2006

Twinrix Paediatric

28.8.2006

Twinrix Adult

28.8.2006

Bondenza

28.8.2006

Truvada

28.8.2006

Vfend

28.8.2006

Inductos

28.8.2006

Hepsera

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

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

GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89
B-1330 Rixensart

GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89
B-1330 Rixensart

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

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

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

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

Gilead Sciences International
Limited
Cambridge CB1 6GT
United Kingdom

EU/1/99/112/001-002

23.8.2006

EU/1/96/006/001-003

23.8.2006

EU/1/03/265/001-006

31.8.2006

EU/1/05/315/001

31.8.2006

EU/1/97/029/001-010

31.8.2006

EU/1/96/020/001-009

31.8.2006

EU/1/03/266/001-006

31.8.2006

EU/1/04/305/001

31.8.2006

EU/1/02/212/001-026

31.8.2006

EU/1/02/226/001

31.8.2006

EU/1/03/251/001

31.8.2006

28.8.2006 Orfadin

Swedish Orphan International AB
Drottninggatan 98
S-111 60 Stockholm

EU/1/04/303/001-003

31.8.2006

C 236/6

EN

Official Journal of the European Union

30.9.2006

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

28.8.2006

Karvezide

28.8.2006

Revatio

28.8.2006

CoAprovel

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

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

Sanofi Pharma Bristol-Myers
Squibb SNC
174, avenue de France
F-75013 Paris

EU/1/98/085/023-028

31.8.2006

EU/1/05/318/001

1.9.2006

EU/1/98/086/023-028

31.8.2006

— 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

10.8.2006

Equilis Prequenza

10.8.2006

Equilis Prequenza te

21.8.2006

Vaxxitek HVT+ IBD

21.8.2006

Naxcel

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Merial
29, avenue Tony Garnier
F-69007 Lyon

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

EU/2/05/056/003-004

14.8.2006

EU/2/05/057/003-004

14.8.2006

EU/2/02/032/001

23.8.2006

EU/2/05/053/002

23.8.2006

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