Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2007 to 31 July 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2007-08-31
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 July 2007 to 31 July 2007

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

(2007/C 203/03)

— 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
Therapeutic
Chemical Code)

Date of
notification

20.7.2007

MIRCERA

methoxy polyethylene glycol-epoetin
beta

23.7.2007

Orlistat GSK

Orlistat

23.7.2007

OptiMARK

Gadoversetamide

30.7.2007

Aerinaze

desloratadine/pseudoephedrine
sulphate

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

Glaxo Group Limited
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

EU/1/07/400/001-016

Solution for injection

B03XA03

25.7.2007

EU/1/07/401/001-006

Capsule, hard

A08AB01

25.7.2007

EU/1/07/398/001-014

Solution for injection

V08CA06

25.7.2007

EU/1/07/399/001-006

Release tablet

R06A X27

1.8.2007

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

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C 203/4

EN

Official Journal of the European Union

31.8.2007

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

Accepted

Date of the
decision

Name of the
medicinal
product

2.7.2007

Cellcept

2.7.2007

Apidra

2.7.2007

Exjade

2.7.2007

Telzir

2.7.2007

Aptivus

2.7.2007

Stocrin

2.7.2007

Sustiva

2.7.2007

Naglazyme

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

Sanofi-Aventis Deutschland GmbH
Brueningstraße 50
D-65926 Frankfurt am Main

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

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

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

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

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

BioMarin Europe Limited
Axtell House
23-24 Warwick Street
London W1B 5NQ
United Kingdom

EU/1/96/005/001-006

5.7.2007

EU/1/04/285/001-036

5.7.2007

EU/1/06/356/001-006

5.7.2007

EU/1/04/282/001-002

5.7.2007

EU/1/05/315/001

5.7.2007

EU/1/99/111/001-011

5.7.2007

EU/1/99/110/001-009

5.7.2007

EU/1/05/324/001

5.7.2007

3.7.2007

Ammonaps

Swedish Orphan International AB
Drottninggatan 98
S-111 60 Stockholm

EU/1/99/120/003-004

5.7.2007

9.7.2007

Zyprexa

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

9.7.2007

Avonex

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

11.7.2007

EU/1/96/022/002
EU/1/96/022/004
EU/1/96/022/006
EU/1/96/022/008-012
EU/1/96/022/014
EU/1/96/022/016-017
EU/1/96/022/019-034

EU/1/97/033/002-004

11.7.2007

31.8.2007

EN

Official Journal of the European Union

C 203/5

Date of the
decision

Name of the
medicinal
product

9.7.2007

Rebetol

9.7.2007

IntronA

9.7.2007

Simulect

9.7.2007

Vfend

16.7.2007

Neupopeg

16.7.2007

Neulasta

20.7.2007

Xigris

20.7.2007

Optison

20.7.2007

Prialt

20.7.2007

REYATAZ

23.7.2007

Trisenox

24.7.2007

RotaTeq

24.7.2007

Zostavax

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

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

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

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

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

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

GE Healthcare AS
Nycoveien 1-2
P.O.Box 4220 Nydalen
N-0401 Oslo

Eisai Limited, 3
Shortlands
London W6 8EE
United Kingdom

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

Cephalon Europe
5, Rue Charles Martigny
F-94700 Maisons Alfort, Cedex

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

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

EU/1/99/107/001-005

11.7.2007

EU/1/99/127/001-044

11.7.2007

EU/1/98/084/001-002

11.7.2007

EU/1/02/212/001-026

11.7.2007

EU/1/02/228/001-003

18.7.2007

EU/1/02/227/001-003

18.7.2007

EU/1/02/225/001-002

27.7.2007

EU/1/98/065/001-002

26.7.2007

EU/1/04/302/001-004

25.7.2007

EU/1/03/267/001-007

25.7.2007

EU/1/02/204/001

25.7.2007

EU/1/06/348/001-002

26.7.2007

EU/1/06/341/001-013

26.7.2007

C 203/6

EN

Official Journal of the European Union

31.8.2007

Date of the
decision

Name of the
medicinal
product

24.7.2007

Crixivan

24.7.2007

Telzir

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

EU/1/96/024/001-005
EU/1/96/024/007-008
EU/1/96/024/010

26.7.2007

EU/1/04/282/001-002

26.7.2007

24.7.2007

Prezista

Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse

EU/1/06/380/001

26.7.2007

24.7.2007

Tarceva

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

EU/1/05/311/001-003

26.7.2007

24.7.2007

Twinrix Adult

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

EU/1/96/020/001-009

26.7.2007

24.7.2007

Onsenal

Pharmacia-Pfizer EEIG
Ramsgate Road
Sandwich CT13 9NJ
United Kingdom

EU/1/03/259/001-006

27.7.2007

24.7.2007

Helixate
NexGen

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/00/144/001-003

27.7.2007

24.7.2007

KOGENATE
Bayer

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/00/143/001-009

27.7.2007

24.7.2007

Preotact

Nycomed Danmark ApS
Langebjerg 1
DK-4000 Roskilde

EU/1/06/339/001-002

27.7.2007

24.7.2007

Remicade

24.7.2007

Gardasil

24.7.2007

Silgard

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

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

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

EU/1/99/116/001-003

27.7.2007

EU/1/06/357/001-017

27.7.2007

EU/1/06/358/001-017

27.7.2007

31.8.2007

EN

Official Journal of the European Union

C 203/7

Date of the
decision

Name of the
medicinal
product

24.7.2007

ReFacto

24.7.2007

Advate

25.7.2007

Rapamune

25.7.2007

Kaletra

25.7.2007

Temodal

25.7.2007

Aclasta

25.7.2007

Agenerase

30.7.2007

BeneFix

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

EU/1/99/103/001-004

27.7.2007

EU/1/03/271/001-004

27.7.2007

EU/1/01/171/001
EU/1/01/171/007-012

30.7.2007

EU/1/01/172/001-005

30.7.2007

EU/1/98/096/001-012

30.7.2007

EU/1/05/308/001-002

30.7.2007

EU/1/00/148/001-004

30.7.2007

EU/1/97/047/004-007

1.8.2007

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

Baxter AG
Industriesstrasse 67
A-1220 Vienna

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

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

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

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

30.7.2007

Velcade

Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse

EU/1/04/274/001

1.8.2007

30.7.2007

Suboxone

30.7.2007

Prevenar

30.7.2007

Axura

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

Wyeth-Lederle Vaccines S.A.
Rue du Bosquet, 15
B-1348 Louvain-La-Neuve

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

EU/1/06/359/001-004

1.8.2007

EU/1/00/167/001-007

1.8.2007

EU/1/02/218/001-011

2.8.2007

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

Date of the
decision

Name of the
medicinal
product

9.7.2007

Trudexa

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/03/257/001-010

11.7.2007

— Issuing of a marketing authorization (Article 38 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
Therapeutic
Chemical Code)

Date of
notification

10.7.2007

Suprelorin

Deslorelin acetate

Cyton Biosciences Ltd
Hyland Mews
21 High Street
Clifton
Bristol BS8 2YF
United Kingdom

EU/2/07/072/001-002

Implant

QH01CA93

12.7.2007

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31.8.2007

EN

Official Journal of the European Union

C 203/9

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

Accepted

Date of the
decision

Name of the
medicinal
product

16.7.2007

ProteqFlu

16.7.2007

Advocate

24.7.2007

ProMeris Duo

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Bayer HealthCare AG
D-51368 Leverkusen

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

EU/2/03/037/005

18.7.2007

EU/2/03/039/019-030

18.7.2007

EU/2/06/065/001-010

26.7.2007

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