Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-07-25
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 June 2008 to 30 June 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 188/04)

— 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-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

10.6.2008

Tyverb

Lapatinib

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

EU/1/07/440/001-002

Film-coated tablet

L01XE07

12.6.2008

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

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25.7.2008

EN

Official Journal of the European Union

C 188/7

— 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

2.6.2008

Xyrem

2.6.2008

Dafiro

2.6.2008

Copalia

3.6.2008

Exforge

3.6.2008

Imprida

4.6.2008

Evoltra

6.6.2008

Vaniqa

10.6.2008

Olanzapine
Neopharma

10.6.2008

Imprida

EU/1/05/312/001

4.6.2008

EU/1/06/371/001-033

4.6.2008

EU/1/06/372/001-033

4.6.2008

EU/1/06/370/001-033

5.6.2008

EU/1/06/373/001-003

5.6.2008

EU/1/06/334/001-004

6.6.2008

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

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

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

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

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

Bioenvision Limited
Bassett House
5 Southwell Park Road
Camberley
Surrey GU15 3PU
United Kingdom

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

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

Laboratorios Almirall S.A.
Ronda General Mitre, no 151
E-08022 Barcelona

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

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

EU/1/01/173/001-003

10.6.2008

11.6.2008

EU/1/07/426/001-011

12.6.2008

EU/1/06/373/001-033

12.6.2008

C 188/8

EN

Official Journal of the European Union

25.7.2008

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

10.6.2008

Irbesartan BMS

10.6.2008

Exforge

10.6.2008

Copalia

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

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

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

EU/1/06/375/001-033

12.6.2008

EU/1/06/370/001-033

12.6.2008

EU/1/06/372/001-033

12.6.2008

10.6.2008

Aprovel

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

EU/1/97/046/001-039

12.6.2008

10.6.2008

Olanzapine
Teva

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

10.6.2008

Karvea

10.6.2008

Karvezide

10.6.2008

CoAprovel

10.6.2008

Irbesartan HCT
BMS

10.6.2008

Irbesartan HCT
Winthrop

10.6.2008

Dafiro

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

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

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

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

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

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

EU/1/07/427/001-057

12.6.2008

EU/1/97/049/001-039

12.6.2008

EU/1/98/085/001-034

12.6.2008

EU/1/98/086/001-034

12.6.2008

EU/1/06/369/001-028

12.6.2008

EU/1/06/377/001-028

12.6.2008

EU/1/06/371/001-033

12.6.2008

11.6.2008

Irbesartan
Winthrop

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

EU/1/06/376/001-033

13.6.2008

25.7.2008

EN

Official Journal of the European Union

C 188/9

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

12.6.2008

Optison

17.6.2008

Xenical

GE Healthcare AS
Nycoveien 1-2
P.O.Box 4220 Nydalen
N-0401 Oslo

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

EU/1/98/065/001-002

16.6.2008

EU/1/98/071/001-006

19.6.2008

18.6.2008

Insuman -

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/97/030/028-139

20.6.2008

18.6.2008

Novomix

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/00/142/004-005
EU/1/00/142/009-022

20.6.2008

18.6.2008

Insulin Human
Winthrop

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/06/368/001-057

20.6.2008

18.6.2008

Norvir

18.6.2008

Remicade

18.6.2008

Atripla

18.6.2008

Tamiflu

18.6.2008

Parareg

18.6.2008

Agenerase

18.6.2008

Renagel

19.6.2008

Twinrix
Paediatric

19.6.2008

Rotarix

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

Bristol-Myers Squibb and Gilead
Sciences Limited
Unit 13
Stillorgan Industrial Park
Blackrock Co.
Dublin
Ireland

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

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

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

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

20.6.2008

EU/1/99/116/001-003

20.6.2008

EU/1/07/430/001

23.6.2008

EU/1/02/222/001-004

20.6.2008

EU/1/04/293/001-012

20.6.2008

EU/1/00/148/001-004

20.6.2008

EU/1/99/123/005-012

20.6.2008

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

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

EU/1/97/029/001-010

23.6.2008

EU/1/05/330/001-004

23.6.2008

C 188/10

EN

Official Journal of the European Union

25.7.2008

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

19.6.2008

Cholestagel

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

EU/1/03/268/001-004

23.6.2008

19.6.2008

Plavix

19.6.2008

Iscover

19.6.2008

InductOs

19.6.2008

Paxene

19.6.2008

Mimpara

19.6.2008

Twinrix Adult

20.6.2008

PEGASYS

20.6.2008

Viracept

20.6.2008

Azopt

20.6.2008

Tysabri

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

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

EU/1/98/069/001a-
007b, 008-010

23.6.2008

EU/1/98/070/001a-
007b, 008-010

23.6.2008

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

Norton Healthcare Limited
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

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

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

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

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

Elan Pharma International Ltd
Monksland
Athlone
County Westmeath
Ireland

EU/1/02/226/001

23.6.2008

EU/1/99/113/001-004

24.6.2008

EU/1/04/292/001-012

23.6.2008

EU/1/96/020/001-009

23.6.2008

EU/1/02/221/001-010

24.6.2008

EU/1/97/054/001
EU/1/97/054/004-005

24.6.2008

EU/1/00/129/001-003

24.6.2008

EU/1/06/346/001

26.6.2008

25.7.2008

EN

Official Journal of the European Union

C 188/11

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

20.6.2008

REYATAZ

20.6.2008

Evra

20.6.2008

Crixivan

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

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

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

EU/1/03/267/001-009

24.6.2008

EU/1/02/223/001-003

24.6.2008

EU/1/96/024/001-005
EU/1/96/024/007-08
EU/1/96/024/010

24.6.2008

20.6.2008

Apidra

Sanofi-Aventis Deutschland GmbH
Brueningstrasse, 50
D-65926 Frankfurt am Main

EU/1/04/285/001-036

24.6.2008

20.6.2008

Prezista

20.6.2008

ProQuad

20.6.2008

Abilify

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

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

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

EU/1/06/380/001

24.6.2008

EU/1/05/323/001-013

24.6.2008

EU/1/04/276/036

24.6.2008

20.6.2008

M-M-RVAXPRO Sanofi Pasteur MSD, SNC

EU/1/06/337/001-013

24.6.2008

20.6.2008

Puregon

20.6.2008

Kaletra

20.6.2008

Vistide

20.6.2008

Raptiva

20.6.2008

Prevenar

8, rue Jonas Salk
F-69007 Lyon

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/96/008/001-041

24.6.2008

EU/1/01/172/001-006

24.6.2008

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

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

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

EU/1/97/037/001-

24.6.2008

EU/1/04/291/001-002

24.6.2008

EU/1/00/167/001-008

24.6.2008

C 188/12

EN

Official Journal of the European Union

25.7.2008

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

20.6.2008

Rapilysin

20.6.2008

Avonex

20.6.2008

Vfend

20.6.2008

Telzir

23.6.2008

Humira

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

Actavis Group PTC ehf.
Reykjavikurvegi 76-78
IS-220 Hafnarfjordur

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

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

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/97/033/002

24.6.2008

24.6.2008

EU/1/97/033/002-004

24.6.2008

EU/1/02/212/001-026

24.6.2008

EU/1/04/282/001-002

24.6.2008

EU/1/03/256/001-010

25.6.2008

25.6.2008

Optisulin

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/133/001-007

27.6.2008

25.6.2008

Baraclude

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

EU/1/06/343/001-007

27.6.2008

25.6.2008

Lantus

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/001-037

27.6.2008

25.6.2008

Temodal

25.6.2008

Elaprase

27.6.2008

Abseamed

30.6.2008

Sprycel

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

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

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

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

EU/1/98/096/001-012

27.6.2008

EU/1/06/365/001-003

27.6.2008

EU/1/07/412/001-020

1.7.2008

EU/1/06/363/001-009

2.7.2008

25.7.2008

EN

Official Journal of the European Union

C 188/13

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

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

25.6.2008

Tygacil

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

EU/1/06/336/001

27.6.2008

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

with effect from 1 January 2009)

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

10.6.2008

Zenapax

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

EU/1/99/098/001-002

12.6.2008

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

Date of the
decision

Name of the medicinal
product

23.6.2008

Posatex

INN
(International Non-Proprie-
tary Name)

Orbifloxacin, Mometa-
sone furoate, Posacona-
zole

25.6.2008

EQUIOXX

Firocoxib

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical Therapeutic
Chemical Code)

Date of
notification

S-P Veterinary
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
United Kingdom

MERIAL
29, avenue Tony Garnier
F-69007 Lyon

EU/2/08/081/001-003

Ear drops, suspension

QS02CA91

25.6.2008

EU/2/08/083/001

Oral paste

QM01AH90

27.6.2008

— 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

3.6.2008

Convenia

4.6.2008

Aivlosin

13.6.2008

Gonazon

20.6.2008

DRAXXIN

23.6.2008

Nobilis Influ-
enza H7N1

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

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

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

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

EU/2/06/059/001

5.6.2008

EU/2/04/044/007

6.6.2008

EU/2/03/040/001-002

17.6.2008

EU/2/03/041/001-005

24.6.2008

EU/2/07/073/001-004

25.6.2008

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25.7.2008

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Official Journal of the European Union

C 188/15

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