Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2007 to 28 February 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2007-03-30
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 February 2007 to 28 February 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 73/08)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 Therapeutic
Chemical Code)

Date of notification

12.2.2007

Prezista

darunavir

15.2.2007

Cystadane

Betaine anhydrous

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

Orphan Europe SARL
Immeuble ‘Le Guillaumet’
F-92046 Paris-La-Défense

EU/1/06/380/001

Film-coated tablet

J05AE10

14.2.2007

EU/1/06/379/001

Oral powder

A16A A06

19.2.2007

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

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C 73/10

EN

Official Journal of the European Union

30.3.2007

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

European Parliament and of the Council): 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

1.2.2007

Xyrem

5.2.2007

Aldurazyme

9.2.2007

ReFacto

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

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

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

EU/1/05/312/001

5.2.2007

EU/1/03/253/001-003

7.2.2007

EU/1/99/103/001-004

13.2.2007

12.2.2007

Replagal

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

EU/1/01/189/001-006

14.2.2007

15.2.2007

BeneFIX

15.2.2007

Trisenox

15.2.2007

Fabrazyme

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

Cephalon UK Ltd
20 Alan Turing Road
Surrey Research Park
Guildford
Surrey GU2 7YF
United Kingdom

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

EU/1/97/047/001-003

19.2.2007

EU/1/02/204/001

19.2.2007

EU/1/01/188/001-006

19.2.2007

20.2.2007

Ammonaps

Swedish Orphan International AB
Drottninggatan 98
S-111 60 Stockholm

EU/1/99/120/001-004

22.2.2007

20.2.2007

Zavesca

20.2.2007

Azopt

20.2.2007

Erbitux

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

Alcon Laboratories (UK) Ltd
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom

Merck KGaA
Frankfurter Straße 250
D-64293 Darmstadt

EU/1/02/238/001

22.2.2007

EU/1/00/129/001-003

22.2.2007

EU/1/04/281/002-005

22.2.2007

30.3.2007

EN

Official Journal of the European Union

C 73/11

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

20.2.2007

Lumigan

Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland

EU/1/02/205/001-002

26.2.2007

21.2.2007

Avonex

23.2.2007

Raptiva

27.2.2007

Comtess

27.2.2007

Comtan

27.2.2007

Norvir

27.2.2007

Erbitux

27.2.2007

Tarceva

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

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

Orion Corporation
Orionintie 1
FIN-02200 Espoo

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United-Kingdom

Merck KGaA
Frankfurter Straße 250
D-64293 Darmstadt

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

EU/1/97/033/001-003

23.2.2007

EU/1/04/291/001-002

27.2.2007

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

1.3.2007

EU/1/98/081/001-004

1.3.2007

EU/1/96/016/001
EU/1/96/016/003-004

1.3.2007

EU/1/04/281/001-005

1.3.2007

EU/1/05/311/001-003

1.3.2007

27.2.2007

Pritor

Bayer HealthCare AG
D-51368 Leverkusen

EU/1/98/089/001-022

1.3.2007

27.2.2007

Aptivus

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

EU/1/05/315/001

1.3.2007

27.2.2007

Levemir

27.2.2007

Zeffix

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/04/278/001-009

1.3.2007

EU/1/99/114/001-003

1.3.2007

C 73/12

EN

Official Journal of the European Union

30.3.2007

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

28.2.2007

EMEND

28.2.2007

Telzir

28.2.2007

Kepivance

28.2.2007

PritorPlus

28.2.2007

Osseor

28.2.2007

Hycamtin

28.2.2007

Protelos

28.2.2007

Agenerase

28.2.2007

Zavesca

28.2.2007

Viread

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

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

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

Bayer HealthCare AG
D-51368 Leverkusen

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

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

Les Laboratoires Servier
22, rue Garnier
F-92200 Neuilly-sur-Seine

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

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

Gilead Sciences International
Limited
Cambridge CB1 6GT
United Kingdom

EU/1/03/262/001-008

2.3.2007

EU/1/04/282/001-002

2.3.2007

EU/1/05/314/001

2.3.2007

EU/1/02/215/001-014

2.3.2007

EU/1/04/287/001-006

2.3.2007

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

2.3.2007

EU/1/04/288/001-006

2.3.2007

EU/1/00/148/001-004

2.3.2007

EU/1/02/238/001

2.3.2007

EU/1/01/200/001

2.3.2007

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

European Parliament and of the Council): 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

9.2.2007

Stronghold

20.2.2007

Nobivac Piro

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

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

EU/2/99/014/001-012

13.2.2007

EU/2/04/046/001-003

22.2.2007

30.3.2007

EN

Official Journal of the European Union

C 73/13

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

20.2.2007

DRAXXIN

20.2.2007

Metacam

23.2.2007

Aivlosin

27.2.2007

Fevaxyn
Pentofel

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

EU/2/03/041/001-005

22.2.2007

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/003-005
EU/2/97/004/012-013
EU/2/97/004/021-025

22.2.2007

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

Fort Dodge Laboratories Ireland
Finisklin Industrial Estate — Sligo
Ireland

EU/2/04/044/001-006

27.2.2007

EU/2/96/002/001-003

2.3.2007