Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-10-31
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 September 2008 to 30 September 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 276/02)

— 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-Proprie-
tary 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

12.9.2008

Oprymea

Pramipexole

15.9.2008

Tevagrastim

Filgrastim

15.9.2008

Biograstim

Filgrastim

15.9.2008

Ratiograstim

Filgrastim

15.9.2008

Filgrastim ratiopharm

Filgrastim

26.9.2008

influenza
Prepandemic
vaccine
(split
(H5N1)
virion inactivated adju-
vanted) GlaxoSmithK-
line Biologicals

vaccine

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

30.9.2008

Xarelto

Rivaroxaban

KRKA, d.d.
Šmarješka cesta 6
SLO-8501 Novo mesto

Teva Generics GmbH
Kandelstr. 10
D-79199 Kirchzarten

CT Arzneimittel GmbH
Lengeder Straße 42a
D-13407 Berlin

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

EU/1/08/469/001-025

Tablet

NO4BC05

15.9.2008

EU/1/08/445/001-008

EU/1/08/450/001-008

EU/1/08/444/001-008

EU/1/08/449/001-008

Solution for
or infusion

Solution for
or infusion

Solution for
or infusion

Solution for
or infusion

injection

L03AA02

17.9.2008

injection

L03AA02

17.9.2008

injection

L03AA02

17.9.2008

injection

L03AA02

17.9.2008

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

EU/1/08/478/001

Suspension and emul-
sion for emulsion for
injection

J07BB02

30.9.2008

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/08/472/001-008

Film-coated tablet

B01AX06

2.10.2008

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

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31.10.2008

EN

Official Journal of the European Union

C 276/3

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

Accepted

Date of the
decision

Name of the
medicinal
product

1.9.2008

Aranesp

1.9.2008

Adenuric

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

Beaufour Ipsen Pharma
24, rue Erlanger
F-75781 Paris Cedex 16

Ipsen Manufacturing Ireland Ltd (IMIL)
Blanchardstown Industrial Park
Snugboro Road
Dublin 15
Ireland

EU/1/01/185/001-073

3.9.2008

EU/1/08/447/001-004

3.9.2008

3.9.2008

1.9.2008

Rotarix

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

EU/1/05/330/001-011

3.9.2008

1.9.2008

Zostavax

2.9.2008

Ziagen

2.9.2008

Lucentis

2.9.2008

Olanzapine
Neopharma

2.9.2008

SonoVue

2.9.2008

Gardasil

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

Neopharma Limited
57 High Street
Odiham
Hampshire RG29 1LF
United Kingdom

Bracco International B.V.
Strawinskylaan 3051
1077 ZX Amsterdam
Nederland

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

EU/1/06/341/001-013

3.9.2008

EU/1/99/112/001-002

4.9.2008

EU/1/06/374/001

4.9.2008

EU/1/07/426/001-011

4.9.2008

EU/1/01/177/002

4.9.2008

EU/1/06/357/001-021

5.9.2008

2.9.2008

Viramune

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

EU/1/97/055/001-003

4.9.2008

2.9.2008

Ventavis

2.9.2008

Silgard

Bayer Schering Pharma AG
Müllerstraße 170-178
D-13342 Berlin

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

EU/1/03/255/001-006

4.9.2008

EU/1/06/358/001-021

4.9.2008

C 276/4

EN

Official Journal of the European Union

31.10.2008

Date of the
decision

Name of the
medicinal
product

2.9.2008

Cetrotide

2.9.2008

Olanzapine
Teva -

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

Teva Pharma B.V.
Computerweg 10
DR Utrecht 3542
Nederland

EU/1/99/100/001-003

5.9.2008

EU/1/07/427/001-057

4.9.2008

2.9.2008

Elaprase

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

EU/1/06/365/001-003

4.9.2008

3.9.2008

Tysabri

3.9.2008

Comtess

3.9.2008

Aldara

3.9.2008

Tamiflu

Elan Pharma International Ltd
Monksland
Athlone
County Westmeath
Ireland

Orion Corporation
Orionintie 1
FI-02200 Espoo

Meda AB
Pipers väg 2A
S-170 73 Solna

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

EU/1/06/346/001

8.9.2008

EU/1/98/082/001-003
EU/1/98/082/005

8.9.2008

EU/1/98/080/001

5.9.2008

EU/1/02/222/001-004

5.9.2008

3.9.2008

Mirapexin

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

EU/1/97/051/001-006
EU/1/97/051/009-012

5.9.2008

3.9.2008

Aldara

Meda AB
Pipers väg 2A
S-170 73 Solna

3.9.2008

Comtan

3.9.2008

Cialis

5.9.2008

Mircera

5.9.2008

Herceptin

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

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

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

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

EU/1/98/080/001

5.9.2008

EU/1/98/081/001-004

8.9.2008

EU/1/02/237/001-008

5.9.2008

EU/1/07/400/017-021

9.9.2008

EU/1/00/145/001

9.9.2008

31.10.2008

EN

Official Journal of the European Union

C 276/5

Date of the
decision

Name of the
medicinal
product

5.9.2008

Puregon

5.9.2008

Epivir

8.9.2008

Evra

9.9.2008

Herceptin

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Organon N.V.
Kloosterstraat 6
Postbus 20
5340 BH Oss
Nederland

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

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

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

EU/1/96/008/038-041

9.9.2008

EU/1/96/015/001-005

9.9.2008

EU/1/02/223/001-003

10.9.2008

EU/1/00/145/001

11.9.2008

12.9.2008

Viread

Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom

EU/1/01/200/001-002

15.9.2008

15.9.2008

Sustiva

15.9.2008

Glubrava

15.9.2008

Stalevo

16.9.2008

Combivir

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

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

EU/1/99/110/001-009

17.9.2008

EU/1/07/421/001-009

17.9.2008

Orion Corporation
Orionintie 1
FI-02200 Espoo

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

EU/1/03/260/001-023

17.9.2008

EU/1/98/058/001-002

18.9.2008

17.9.2008

Optisulin

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/133/001-008

19.9.2008

17.9.2008

Lantus

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/001-037

19.9.2008

22.9.2008

Emtriva

Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom

EU/1/03/261/001-003

24.9.2009

22.9.2008

Emend

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

EU/1/03/262/001-008

24.9.2008

C 276/6

EN

Official Journal of the European Union

31.10.2008

Date of the
decision

Name of the
medicinal
product

26.9.2008

Aclasta

26.9.2008

Thelin

29.9.2008

Mycamine

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

Astellas Pharma Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
Nederland

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

EU/1/05/308/001-002

30.9.2008

EU/1/06/353/001-005

30.9.2008

EU/1/08/448/001-002

1.10.2008

1.10.2008

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

Date of the
decision

Name of the
medicinal
product

26.9.2008

Exubera

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

EU/1/05/327/001-018

30.9.2008

— 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-Proprie-
tary 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

9.9.2008

Trocoxil

Mavacoxib

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/2/08/084/001-005

Chewable tablets

QM01AH92

11.9.2008

— 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

2.9.2008

Advocate

Bayer Animal Health GmbH
D-51368 Leverkusen

EU/2/03/039/001-030

4.9.2008

Bayer HealthCare AG
D-51368 Leverkusen

4.9.2008

5.9.2008

Profender

Bayer Animal Health GmbH
D-51368 Leverkusen

EU/2/05/054/001-031

9.9.2008

15.9.2008

Oxyglobin

19.9.2008

DRAXXIN

Bayer HealthCare AG
D-51368 Leverkusen

Biopure Netherlands B.V.
Parnassustoren
Locatellikade 1
1076 AZ Amsterdam
Nederland

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

9.9.2008

EU/2/99/015/002

17.9.2008

EU/2/03/041/001-005

23.9.2008

26.9.2008

PRAC-TIC

Novartis Sanidad Animal S.L.
Calle de la Marina, 206
E-Barcelona 08013

EU/2/06/066/001-012

30.9.2008

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C 276/8

EN

Official Journal of the European Union

31.10.2008

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

Date of the
decision

Name of the
medicinal
product

26.9.2008

Porcilis Pesti

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

EU/2/99/016/001-006

30.9.2008

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