Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 May 2008 to 31 May 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-06-27
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 May 2008 to 31 May 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 164/08)

— 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

14.5.2008

Prepandrix

20.5.2008

Pandemrix

Prepandemic influenza vaccine (H5N1)
inactivated, adjuvanted)
(split virion,
A/VietNam/1194/2004 NIBRG-14

GlaxoSmithKline Biologicals s.a.
rue de l'Institut, 89
B-1330 Rixensart

Pandemic influenza vaccine (H5N1)
(split virion,
inactivated, adjuvanted)
A/VietNam/1194/2004 NIBRG-14

GlaxoSmithKline Biologicals s.a.
rue de l'Institut, 89
B-1330 Rixensart

20.5.2008

Extavia

Interferon beta-1b

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

EU/1/08/453/001

EU/1/08/452/001

EU/1/08/454/001-004

Suspension and emul-
sion for emulsion for
injection

Suspension and emul-
sion for emulsion for
injection

Powder and solvent for
solution for injection

ATC code
(Anatomical
Therapeutic Chem-
ical Code)

Date of
notification

J07BB02

16.5.2008

J07BB02

22.5.2008

L03AB08

22.5.2008

C

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6
4
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6

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

.

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2
7
6
2
0
0
8

27.6.2008

EN

Official Journal of the European Union

C 164/7

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

Date of the
decision

Name of the
medicinal
product

21.5.2008

CIMZIA

22.5.2008

Rhucin

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

UCB S.A.
Allée de la Recherche, 60
B-1070 Bruxelles

Researchdreef, 60
B-1070 Brussel

Pharming Group N.V.
Darwinweg 24
2333 CR Leiden
Nederland

—

23.5.2008

—

28.5.2008

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

Accepted

Date of the
decision

Name of the
medicinal
product

8.5.2008

Ebixa

8.5.2008

Ebixa

8.5.2008

Axura

8.5.2008

Axura

21.5.2008

Prometax

21.5.2008

Xagrid

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby

Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100-104
D-60318 Frankfurt/Main

Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100-104
D-60318 Frankfurt/Main

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

EU/1/02/219/001-049

14.5.2008

EU/1/02/219/022-049

14.5.2008

EU/1/02/218/001-029

14.5.2008

EU/1/02/218/016-029

14.5.2008

EU/1/98/092/001-026

23.5.2008

EU/1/04/295/001

23.5.2008

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

21.5.2008

Foscan

Biolitec pharma Ltd
United Drug House
Magna Drive
Dublin 24
Ireland

EU/1/01/197/001-005

23.5.2008

22.5.2008

Zevalin

Bayer Schering Pharma AG
D-13342 Berlin

EU/1/03/264/001

27.5.2008

C 164/8

EN

Official Journal of the European Union

27.6.2008

Date of the
decision

Name of the
medicinal
product

22.5.2008

Advate

20.5.2008

Forsteo

20.5.2008

Carbaglu

20.5.2008

Exelon

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Baxter AG
Industriesstraße 67
A-1220 Vienna

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

Orphan Europe
Immeuble Le Wilson
70, Avenue du Général de Gaulle
F-92800 Puteaux

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

EU/1/03/271/005-006

28.5.2008

EU/1/03/247/001-002

22.5.2008

EU/1/02/246/001-003

22.5.2008

EU/1/98/066/001-026

22.5.2008

EU/1/97/035/001-004

22.5.2008

20.5.2008

Refludan

Pharmion Limited
Riverside House
Riverside Walk
Windsor SL4 1NA
United Kingdom

20.5.2008

Cystadane

Orphan Europe S.a.r.l.
Immeuble Le Wilson
70, Avenue du Général de Gaulle
F-92800 Puteaux

EU/1/06/379/001

22.5.2008

20.5.2008

Zavesca

20.5.2008

Mabthera

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

20.5.2008

Aldurazyme

20.5.2008

Onsenal

20.5.2008

Rebif

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

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Serono Europe Limited
56, Marsh Wall
London E14 9TP
United Kingdom

EU/1/02/238/001

22.5.2008

EU/1/98/067/001-002

22.5.2008

EU/1/03/253/001-003

22.5.2008

EU/1/03/259/001-006

22.5.2008

EU/1/98/063/001-007

27.5.2008

27.6.2008

EN

Official Journal of the European Union

C 164/9

— 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

21.5.2008

Nobilis IB 4-91 Intervet International B.V.

EU/2/98/006/001-010

23.5.2008

Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

21.5.2008

METACAM

Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/007-008
EU/2/97/004/014-015
EU/2/97/004/027-028
EU/2/97/004/031-032

23.5.2008

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