Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2007 to 31 October 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2007-11-30
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, veterinary drug

30.11.2007

EN

Official Journal of the European Union

C 288/7

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 October 2007 to 31 October 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 288/04)

— Modification of a marketing authorization (Article 13 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

2.10.2007

ADROVANCE

2.10.2007

Fuzeon

3.10.2007

Aclasta

4.10.2007

Thyrogen

4.10.2007

FOSAVANCE

9.10.2007

Arixtra

9.10.2007

AZILECT

9.10.2007

Quixidar

9.10.2007

Humira

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

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

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

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

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

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

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

Teva Pharma GmbH
Kandelstraße 10
D-79199 Kirchzarten

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/06/364/001-009

4.10.2007

EU/1/03/252/001-003

4.10.2007

EU/1/05/308/001-002

5.10.2007

EU/1/99/122/001-002

8.10.2007

EU/1/05/310/001-009

11.10.2007

EU/1/02/206/001-008

11.10.2007

EU/1/04/304/001-007

11.10.2007

EU/1/02/207/001-008

11.10.2007

EU/1/03/256/001-010

11.10.2007

C 288/8

EN

Official Journal of the European Union

30.11.2007

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

9.10.2007

Myozyme

15.10.2007

Aptivus

15.10.2007

Levemir

15.10.2007

Ionsys

15.10.2007

Foscan

15.10.2007

Enbrel

EU/1/06/333/001-003

11.10.2007

EU/1/05/315/001

19.10.2007

EU/1/04/278/004-006

18.10.2007

EU/1/05/326/001

18.10.2007

EU/1/01/197/003-005

18.10.2007

EU/1/99/126/013-015

18.10.2007

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

Biolitec Pharma Ltd
United Drug House
Magna Drive
Dublin 24
Ireland

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

15.10.2007

Elaprase

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

EU/1/06/365/001-003

18.10.2007

15.10.2007

Zevalin

Bayer Schering Pharma AG
D-13342 Berlin

EU/1/03/264/001

18.10.2007

15.10.2007

Karvezide

15.10.2007

CoAprovel

18.10.2007

Zenapax

18.10.2007

Cialis

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

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

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

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

Lilly ICOS Limited
St Bride's House
10 Salisbury Square
London EC4Y 8EH
United Kingdom

EU/1/98/085/001-034

18.10.2007

EU/1/98/086/001-034

23.10.2007

EU/1/99/098/001-002

23.10.2007

EU/1/02/237/001-008

22.10.2007

24.10.2007

30.11.2007

EN

Official Journal of the European Union

C 288/9

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

19.10.2007

Zometa

19.10.2007

Invirase

19.10.2007

Viracept

19.10.2007

Keppra

19.10.2007

Cellcept

19.10.2007

Fasturtec

22.10.2007

Aptivus

22.10.2007

Fabrazyme

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

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

UCB Pharma SA
Allée de la Recherche, 60/
Researchdreef, 60
B-1070 Bruxelles/Brussel

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

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

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

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

EU/1/01/176/001-006

23.10.2007

EU/1/96/026/001-002

23.10.2007

EU/1/97/054/001
EU/1/97/054/003-005

23.10.2007

EU/1/00/146/001-030

23.10.2007

EU/1/96/005/001-006

23.10.2007

EU/1/00/170/001-002

23.10.2007

EU/1/05/315/001

24.10.2007

EU/1/01/188/001-006

24.10.2007

22.10.2007

Zevalin

Bayer Schering Pharma AG
D-13342 Berlin

EU/1/03/264/001

24.10.2007

23.10.2007

ACOMPLIA

23.10.2007

Tritanrix HepB

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

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

EU/1/06/344/001-011

25.10.2007

EU/1/96/014/001-003

25.10.2007

23.10.2007

Vasovist

Bayer Schering Pharma AG
D-13342 Berlin

EU/1/05/313/001-009

25.10.2007

23.10.2007

Telzir

23.10.2007

Zimulti

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

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

EU/1/04/282/001-002

25.10.2007

EU/1/06/345/001-011

25.10.2007

C 288/10

EN

Official Journal of the European Union

30.11.2007

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

23.10.2007

Hepsera

24.10.2007

Hycamtin

24.10.2007

Competact

24.10.2007

Tamiflu

24.10.2007

Avastin

24.10.2007

Tygacil

24.10.2007

FOSAVANCE

24.10.2007

SUTENT

24.10.2007

Kaletra

29.10.2007

Abilify

EU/1/03/251/001-002

25.10.2007

EU/1/96/027/001
EU/1/96/027/003-005

26.10.2007

EU/1/06/354/001-009

26.10.2007

EU/1/02/222/001-004

26.10.2007

EU/1/04/300/001-002

26.10.2007

EU/1/06/336/001

26.10.2007

EU/1/05/310/001-009

26.10.2007

EU/1/06/347/001-006

26.10.2007

EU/1/01/172/001-005

26.10.2007

EU/1/04/276/033-035

31.10.2007

Gilead Sciences International
Limited
Cambridge CB21 6GT
United Kingdom

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

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

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

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

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

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

29.10.2007

Zonegran

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

EU/1/04/307/001-013

31.10.2007

30.11.2007

EN

Official Journal of the European Union

C 288/11

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

29.10.2007

Luminity

Bristol-Myers Squibb Pharma
Belgium Sprl
Chaussée de la Hulpe, 185/
Terhulpsesteenweg, 185
B-1170 Bruxelles/Brussel

EU/1/06/361/001-002

31.10.2007

29.10.2007

Nexavar

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/06/342/001

31.10.2007

30.10.2007

Noxafil

30.10.2007

Posaconazole SP

30.10.2007

Remicade

30.10.2007

Helixate NexGen

30.10.2007

KOGENATE Bayer

30.10.2007

PegIntron

30.10.2007

ViraferonPeg

30.10.2007

Epivir

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

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

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

Bayer HealthCare AG
D-51368 Leverkusen

Bayer HealthCare AG
D-51368 Leverkusen

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

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

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

EU/1/05/320/001

5.11.2007

EU/1/05/321/001

5.11.2007

EU/1/99/116/001-003

1.11.2007

EU/1/00/144/001-003

2.11.2007

EU/1/00/143/001-009

2.11.2007

EU/1/00/131/001-050

5.11.2007

EU/1/00/132/001-050

5.11.2007

EU/1/96/015/001-005

1.11.2007

30.10.2007

Rebetol

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

EU/1/99/107/001-005

5.11.2007

30.10.2007

Nonafact

31.10.2007

Xyrem

Sanquin
Plesmanlaan 125
1066 CX Amsterdam
Nederland

UCB Pharma Ltd
208 Bath Road
Slough
Berkshire SL1 3WE
United Kingdom

EU/1/01/186/001-002

1.11.2007

EU/1/05/312/001

7.11.2007

31.10.2007

Ammonaps

Swedish Orphan International AB
Drottninggatan 98
S-111 60 Stockholm

EU/1/99/120/001-004

7.11.2007

31.10.2007

Aldurazyme

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

EU/1/03/253/001-003

7.11.2007

C 288/12

EN

Official Journal of the European Union

30.11.2007

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

31.10.2007

Fuzeon

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

EU/1/03/252/001-003

7.11.2007

31.10.2007

ADROVANCE

31.10.2007

Tracleer

31.10.2007

Alimta

31.10.2007

BYETTA

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

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

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

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

EU/1/06/364/001-009

7.11.2007

EU/1/02/220/001-005

7.11.2007

EU/1/04/290/001-002

7.11.2007

EU/1/06/362/001-004

7.11.2007

— Lift of suspension of a marketing authorization (Article 20 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

15.10.2007

Viracept

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

EU/1/97/054/001
EU/1/97/054/003-005

18.10.2007

— 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

9.10.2007

Poulvac FluFend
H5N3 RG

15.10.2007

Purevax FelV

29.10.2007

ProteqFlu Te

Fort Dodge Animal Health Ltd
Flanders Road
Hedge End
Southampton SO30 4QH
United Kingdom

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Merial
29, Avenue Tony Garnier
F-69007 Lyon

EU/2/06/060/001-002

11.10.2007

EU/2/00/019/005-007

18.10.2007

EU/2/03/038/005

31.10.2007

30.11.2007

EN

Official Journal of the European Union

C 288/13

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