Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-03-28
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 February 2008 to 29 February 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 77/02)

— 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-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

21.2.2008

Myfenax

Mycophénolate mofétil

21.2.2008

Mycophenolate mofetil Teva

Mycophénolate mofétil

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

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

EU/1/07/438/001-002

Capsule, hard

L04AA06

25.2.2008

EU/1/07/438/003-004

Film-coated tablet

EU/1/07/439/001-002

Capsule, hard

L04AA06

25.2.2008

EU/1/07/439/003-004

Film-coated tablet

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

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28.3.2008

EN

Official Journal of the European Union

C 77/3

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

Accepted

Date of the
decision

Name of the
medicinal
product

6.2.2008

Sebivo

6.2.2008

Prevenar

6.2.2008

Fabrazyme

7.2.2008

Ytracis

7.2.2008

Levitra

7.2.2008

Vivanza

13.2.2008

Eucreas

13.2.2008

Combivir

14.2.2008

BeneFIX

18.2.2008

ATryn

26.2.2008

Januvia

26.2.2008

Aranesp

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

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

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

CIS bio international
Boite Postale 32
F-91192 Gif-sur-Yvette Cedex

Bayer AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

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

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup

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

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

EU/1/07/388/001-002

8.2.2008

EU/1/00/167/001-007

8.2.2008

EU/1/01/188/001-006

8.2.2008

EU/1/03/250/001

11.2.2008

EU/1/03/248/001-012

11.2.2008

EU/1/03/249/001-012

11.2.2008

EU/1/07/425/001-018

15.2.2008

EU/1/98/058/001-002

15.2.2008

EU/1/97/047/001-007

18.2.2008

EU/1/06/355/001-003

20.2.2008

EU/1/07/383/001-018

28.2.2008

EU/1/01/185/001-073

28.2.2008

26.2.2008

Abseamed

Medice Arzneimittel Pütter GmbH
& Co KG
Kuhloweg 37
D-58638 Iserlohn

EU/1/07/412/001-016

28.2.2008

C 77/4

EN

Official Journal of the European Union

28.3.2008

Date of the
decision

Name of the
medicinal
product

26.2.2008

NeoRecormon

26.2.2008

Nespo

26.2.2008

Xelevia

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

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

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

EU/1/97/031/019-046

28.2.2008

EU/1/01/184/001-073

28.2.2008

EU/1/07/382/001-018

28.2.2008

26.2.2008

Arava

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-010

28.2.2008

26.2.2008

NeuroBloc

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

26.2.2008

Avastin

26.2.2008

Kepivance

28.2.2008

Erbitux

28.2.2008

Hepsera

28.2.2008

Fasturtec

28.2.2008

TRIZIVIR

28.2.2008

Truvada

28.2.2008

Champix

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

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

Merck KgaA
Frankfurter Straße 250
D-64293 Darmstadt

Gilead Sciences International
Limited
Cambridge CB21 6GT
United Kingdom

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

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

Gilead Sciences International
Limited
Cambridge CB21 6GT
United Kingdom

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

EU/1/00/166/001-003

28.2.2008

EU/1/04/300/001-002

28.2.2008

EU/1/05/314/001

28.2.2008

EU/1/04/281/002-005

3.3.2008

EU/1/03/251/001-002

3.3.2008

EU/1/00/170/001-002

3.3.2008

EU/1/00/156/002-003

3.3.2008

EU/1/04/305/001

3.3.2008

EU/1/06/360/001-011

3.3.2008

28.3.2008

EN

Official Journal of the European Union

C 77/5

Date of the
decision

Name of the
medicinal
product

28.2.2008

Sebivo

28.2.2008

Telzir

28.2.2008

CellCept

28.2.2008

Sifrol

29.2.2008

Osigraft

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

EU/1/07/388/001-002

3.3.2008

EU/1/04/282/001-002

3.3.2008

EU/1/96/005/001-006

3.3.2008

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

3.3.2008

EU/1/01/179/001

4.3.2008

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

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

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

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

Howmedica International S. de R.L.
Division of Stryker Corporation
Raheen Industrial Estate
Raheen
Limerick
Ireland

29.2.2008

Ziagen

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/99/112/001-002

4.3.2008

29.2.2008

Epoetin alfa
Hexal

HEXAL Biotech Forschungs GmbH
Industriestraße 25
D-83607 Holzkirchen

EU/1/07/411/001-016

4.3.2008

29.2.2008

Lyrica

29.2.2008

Dynepo

EU/1/04/279/001-043

4.3.2008

EU/1/02/211/001-005
EU/1/02/211/010-012

4.3.2008

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

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

29.2.2008

Cialis

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

EU/1/02/237/001-008

4.3.2008

29.2.2008

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

4.3.2008

C 77/6

EN

Official Journal of the European Union

28.3.2008

Date of the
decision

Name of the
medicinal
product

29.2.2008

Binocrit

29.2.2008

Abilify

29.2.2008

Kivexa

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/07/410/001-016

4.3.2008

EU/1/04/276/001-032

4.3.2008

EU/1/04/298/001-003

4.3.2008

— 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-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

13.2.2008

Ingelvac CircoFLEX

Porcine circovirus type 2 ORF2
protein minimum RP
1,0,
maximum RP 3,75

Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein

EU/2/07/079/001-004

Suspension for injection

QI09AA07

15.2.2008

— 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

5.2.2008

Aivlosin

7.2.2008

Nobilis Influenza
H5N2

ECO Animal Health Ltd
78 Coombe Road
New Malden
Surrey KT3 4QS
United Kingdom

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

EU/2/04/044/001-002

7.2.2008

EU/2/06/061/001-004

11.2.2008

7.2.2008

Advocate

Bayer HealthCare AG
D-51368 Leverkusen

EU/2/03/039/001-030

11.2.2008

— Withdrawal of a marketing authorization (Article 38 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

6.2.2008

Advasure

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

EU/2/00/025/001-004

8.2.2008

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C 77/8

EN

Official Journal of the European Union

28.3.2008

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