Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2007 to 30 June 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2007-07-27
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 June 2007 to 30 June 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 174/04)

— 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

1.6.2007

Optaflu

Influenza
inactivated, prepared in cell culture)

(surface

vaccine

antigen,

14.6.2007

Revlimid

Lenalidomide

20.6.2007

Soliris

Eculizumab

25.6.2007

Invega

Paliperidone

25.6.2007

Pergoveris

Follitropin alfa/lutropin alfa

29.6.2007

Circadin

Melatonin

29.6.2007

Siklos

Hydroxycarbamide

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

Novartis Vaccines and Diagnostics
GmbH & Co. KG
Emil-von-Behring-Straße 76
D-35041 Marburg

Celgene Europe Limited
8 The Square
Stockley Park
Uxbridge UB11 1FW
Middlesex
United Kingdom

Alexion Europe SAS
54-56, Avenue Hoche
F-75008 Paris

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

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

Neurim Pharmaceuticals EEC Limited
6 Fortuna Court
Calleva Park
Aldermaston
Berkshire RG7 8UB
United Kingdom

Addmedica
84, rue d'Amsterdam
F-75009 Paris

EU/1/07/394/001-006

Suspension for injection
in pre-filled syringe

J07BB02

5.6.2007

EU/1/07/391/001-004

Hard capsule

L04AX04

19.6.2007

EU/1/07/393/001

for
Concentrate
tion for infusion

solu-

Non applicable

22.6.2007

EU/1/07/395/001-064

Prolonged release tablet 5N05AX13

27.6.2007

EU/1/07/396/001-003

Powder and solvent for
solution for injection

G03GA05/
G03GA07

27.6.2007

EU/1/07/392/001

Prolonged-release tablet N05CM17

5.7.2007

EU/1/07/397/001

Film-coated tablet

L01XX05

5.7.2007

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C 174/4

EN

Official Journal of the European Union

27.7.2007

— 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

1.6.2007

Renagel

1.6.2007

Rebetol

4.6.2007

Myocet

4.6.2007

Vasovist

4.6.2007

Aptivus

4.6.2007

Humira

4.6.2007

Trudexa

4.6.2007

Orgalutran

4.6.2007

TRIZIVIR

4.6.2007

Zometa

4.6.2007

Avandamet

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

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

Zeneus Pharma Limited
The Magdalen Centre
Oxford Science Park
Oxford OX4 4GA
United Kingdom

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

EU/1/99/123/001-012

5.6.2007

EU/1/99/107/001-005

5.6.2007

EU/1/00/141/001

7.6.2007

6.6.2007

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

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

EU/1/05/313/001-009

6.6.2007

EU/1/05/315/001

6.6.2007

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

N.V. Organon
P.O. Box 20
Kloosterstraat 6
5340 BH Oss
Nederland

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

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

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

EU/1/03/256/001-010

6.6.2007

EU/1/03/257/001-010

6.6.2007

EU/1/00/130/001-002

6.6.2007

EU/1/00/156/002-003

6.6.2007

EU/1/01/176/001-006

6.6.2007

EU/1/03/258/001-022

6.6.2007

27.7.2007

EN

Official Journal of the European Union

C 174/5

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

5.6.2007

Azomyr

5.6.2007

Aerius

5.6.2007

Neoclarityn

5.6.2007

Abilify

5.6.2007

Trisenox

5.6.2007

Visudyne

7.6.2007

Tracleer

8.6.2007

Levemir

8.6.2007

Vistide

13.6.2007

ViraferonPeg

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

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

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

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

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

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Pfizer Enterprises SARL
51, Avenue Kennedy-Rond Point
du Kirchberg
L-1855 Luxembourg

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

EU/1/00/157/001-067

7.6.2007

EU/1/00/160/001-069

8.6.2007

EU/1/00/161/001-067

7.6.2007

EU/1/04/276/001-020
EU/1/04/276/024-036

7.6.2007

EU/1/02/204/001

8.6.2007

7.6.2007

EU/1/00/140/001

7.6.2007

EU/1/02/220/001-005

11.6.2007

EU/1/04/278/001-009

12.6.2007

EU/1/97/037/001

12.6.2007

EU/1/00/132/001-050

15.6.2007

C 174/6

EN

Official Journal of the European Union

27.7.2007

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

13.6.2007

Azopt

13.6.2007

Tracleer

13.6.2007

Gardasil

13.6.2007

Ebixa

13.6.2007

PegIntron

13.6.2007

Silgard

14.6.2007

Rapilysin

19.6.2007

Zyprexa Velotab

20.6.2007

Axura

20.6.2007

Cialis

21.6.2007

Levemir

21.6.2007

PEGASYS

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

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

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

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby

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

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

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

EU/1/00/129/001-003

15.6.2007

EU/1/02/220/001-005

15.6.2007

EU/1/06/357/001-017

15.6.2007

EU/1/02/219/001-015

15.6.2007

EU/1/00/131/001-050

15.6.2007

EU/1/06/358/001-017

15.6.2007

EU/1/96/018/001

19.6.2007

EU/1/99/125/001-016

21.6.2007

EU/1/02/218/001-011

25.6.2007

EU/1/02/237/001-008

21.6.2007

EU/1/04/278/001-009

25.6.2007

EU/1/02/221/001-010

25.6.2007

27.7.2007

EN

Official Journal of the European Union

C 174/7

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

21.6.2007

Hycamtin

21.6.2007

Iscover

21.6.2007

Synagis

21.6.2007

Forsteo

21.6.2007

Revasc

21.6.2007

Cystagon

21.6.2007

PEGASYS

22.6.2007

Plavix

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

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

25.6.2007

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

EU/1/98/070/001a-001b
EU/1/98/070/002a-002b
EU/1/98/070/003a-003b
EU/1/98/070/004a-004b
EU/1/98/070/005a-005b
EU/1/98/070/006a-006b
EU/1/98/070/007a-007b

25.6.2007

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

Canyon Pharmaceuticals Ltd
20-22 Bedford Row
London WC1R 4JS
United Kingdom

Orphan Europe S.à r.l.
Immeuble «Le Guillaumet»
F-92046 Paris La Défense

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

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

EU/1/99/117/001-002

25.6.2007

EU/1/03/247/001-002

25.6.2007

EU/1/97/043/001-003

25.6.2007

EU/1/97/039/001-004

25.6.2007

EU/1/02/221/001-010

25.6.2007

26.6.2007

EU/1/98/069/001a-001b
EU/1/98/069/002a-002b
EU/1/98/069/003a-003b
EU/1/98/069/004a-004b
EU/1/98/069/005a-005b
EU/1/98/069/006a-006b
EU/1/98/069/007a-007b

EU/1/06/337/001-013

27.6.2007

EU/1/97/031/001-003
EU/1/97/031/019-046

27.6.2007

EU/1/01/173/001-003

29.6.2007

25.6.2007

M-M-RVAXPRO

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

25.6.2007

NeoRecormon

27.6.2007

Vaniqa

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

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

C 174/8

EN

Official Journal of the European Union

27.7.2007

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

29.6.2007

Tamiflu

29.6.2007

Ferriprox

29.6.2007

Humira

29.6.2007

Viramune

29.6.2007

Trudexa

29.6.2007

Prandin

29.6.2007

NovoNorm

29.6.2007

Tygacil

29.6.2007

Lyrica

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

Apotex Europe Ltd
Rowan House
41 London Street
Reading
Berkshire RG1 4PS
United Kingdom

Apotex Europe B.V.
Darwingweg 20
2333 CR Leiden
Nederland

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/02/222/001-002

3.7.2007

EU/1/99/108/001

3.7.2007

3.7.2007

EU/1/03/256/001-010

5.7.2007

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

EU/1/97/055/001-003

5.7.2007

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

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

EU/1/03/257/001-010

5.7.2007

EU/1/00/162/003-006
EU/1/00/162/009-012
EU/1/00/162/015-021

EU/1/98/076/004-007
EU/1/98/076/011-014
EU/1/98/076/018-024

5.7.2007

5.7.2007

EU/1/06/336/001

5.7.2007

EU/1/04/279/001-035

5.7.2007

— 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

20.6.2007

PRILACTONE

Spironolactone

21.6.2007

Circovac

Inactivated porcine circovirus type 2

CEVA SANTE ANIMALE
Z.I. la Ballastière
F-33500 Libourne

MERIAL
29, avenue Tony Garnier
F-69007 Lyon

EU/2/07/074/001-006

Tablet

QC03DA01

22.6.2007

EU/2/07/075/001-004

Emulsion and suspension for
emulsion for injection

QI09AA07

25.6.2007

— 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

14.6.2007

Vaxxitek HVT+ IBD

Merial
29, Avenue Tony Garnier
F-69007 Lyon

EU/2/02/032/001

19.6.2007

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

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