Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2008-09-26
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 August 2008 to 31 August 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 245/03)

— 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)

28.8.2008

INTELENCE

Etravirine

29.8.2008

Vimpat

Lacosamide

Holder of the marketing authorization

Number of the entry in the
Community Register

Pharmaceutical form

ATC code
(Anatomical
Therapeutic
Chemical Code)

Date of notification

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

UCB S.A.
Allée de la Recherche, 60/Researchdreef, 60
B-1070 Bruxelles/B-1070 Brussel

EU/1/08/468/001

Tablet

(Non applicable)

1.9.2008

EU/1/08/470/001-013

Film-coated tablet

N03AX18

2.9.2008

EU/1/08/470/014-015

Syrup

EU/1/08/470/016

Solution for infusion

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

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C 245/16

EN

Official Journal of the European Union

26.9.2008

— 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

4.8.2008

Neupro

8.8.2008

Champix

8.8.2008

Vectibix

Schwarz Pharma Ltd
Shannon
Industrial Estate
Co.Clare
Ireland

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

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

EU/1/05/331/001-037

6.8.2008

EU/1/06/360/001-012

12.8.2008

EU/1/07/423/001-003

12.8.2008

8.8.2008

Infanrix hexa

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

EU/1/00/152/001-018

12.8.2008

8.8.2008

Evista

8.8.2008

Avandamet

11.8.2008

Optruma

13.8.2008

Silapo

13.8.2008

Retacrit

13.8.2008

Humira

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

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

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

STADA Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel

HOSPIRA Enterprises B.V.
Taurusavenue 19-21b
2132 LS Hoofddorp
Nederland

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/98/073/001-004

12.8.2008

EU/1/03/258/001-022

12.8.2008

EU/1/98/074/001-004

13.8.2008

EU/1/07/432/001-022

15.8.2008

EU/1/07/431/001-019

15.8.2008

EU/1/03/256/001-010

15.8.2008

13.8.2008

Hepsera

Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom

EU/1/03/251/001-002

15.8.2008

13.8.2008

Infanrix penta

13.8.2008

Cervarix

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/1/00/153/001-010

18.8.2008

EU/1/07/419/001-009

18.8.2008

26.9.2008

EN

Official Journal of the European Union

C 245/17

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

22.8.2008

Evista

DAIICHI SANKYO EUROPE GmbH
Zielstattstrasse 48
D-81379 München

EU/1/98/073/001-004

26.8.2008

22.8.2008

Kaletra

22.8.2008

Baraclude

22.8.2008

SUTENT

22.8.2008

Fosavance

22.8.2008

Zalasta

22.8.2008

Arixtra

22.8.2008

Revlimid

25.8.2008

Abilify

25.8.2008

TARGRETIN

25.8.2008

Emselex

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

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

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

KRKA d.d.
Šmarješka cesta 6
SLO-8501 Novo mesto

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

Celgene Europe Limited
Morgan House
Madeira Walk
Windsor
Berkshire SL4 1EP
United Kingdom

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

Eisai Limited
3 Shortlands
London W6 8EE
United Kingdom

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

EU/1/01/172/001-006

26.8.2008

EU/1/06/343/001-007

26.8.2008

EU/1/06/347/001-006

26.8.2008

EU/1/05/310/001-009

26.8.2008

EU/1/07/415/001-056

26.8.2008

EU/1/02/206/001-035

26.8.2008

EU/1/07/391/001-004

26.8.2008

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

27.8.2008

EU/1/01/178/001

27.8.2008

EU/1/04/294/001-028

27.8.2008

C 245/18

EN

Official Journal of the European Union

26.9.2008

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

25.8.2008

Sifrol

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

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

27.8.2008

25.8.2008

Humira

25.8.2008

Revatio

25.8.2008

Prialt

25.8.2008

NovoSeven

26.8.2008

Viagra

28.8.2008

Rasilez

28.8.2008

Tekturna

28.8.2008

Raptiva

28.8.2008

ISENTRESS

28.8.2008

Enviage

28.8.2008

Sprimeo

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Eisai Limited
3 Shortlands
London W6 8EE
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Pfizer Limited
Sandwich
Kent CT13 9NJ
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

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

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
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/1/03/256/001-010

27.8.2008

EU/1/05/318/001

27.8.2008

EU/1/04/302/001-004

27.8.2008

EU/1/96/006/001-006

27.8.2008

EU/1/98/077/002-004
EU/1/98/077/006-008
EU/1/98/077/010-019

28.8.2008

EU/1/07/405/001-020

1.9.2008

EU/1/07/408/001-020

1.9.2008

EU/1/04/291/001-003

1.9.2008

EU/1/07/436/001-002

1.9.2008

EU/1/07/406/001-020

1.9.2008

EU/1/07/407/001-020

1.9.2008

26.9.2008

EN

Official Journal of the European Union

C 245/19

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

28.8.2008

Riprazo

29.8.2008

Avastin

29.8.2008

Nespo

29.8.2008

Enbrel

29.8.2008

Velcade

29.8.2008

Humira

29.8.2008

Prezista

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

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

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

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

EU/1/07/409/001-020

1.9.2008

EU/1/04/300/001-002

2.9.2008

EU/1/01/184/001-073

2.9.2008

EU/1/99/126/001-018

1.9.2008

EU/1/04/274/001-002

2.9.2009

EU/1/03/256/001-010

2.9.2009

EU/1/06/380/001

2.9.2009

29.8.2008

Truvada

Gilead Sciences International Limited
Cambridge CB21 6GT
United Kingdom

EU/1/04/305/001-002

2.9.2009

29.8.2008

Neupro

29.8.2008

Neupro

Schwarz Pharma Ltd
Shannon Industrial Estate
Co.Clare
Ireland

Schwarz Pharma Ltd
Shannon Industrial Estate
Co.Clare
Ireland

EU/1/05/331/038-055

2.9.2009

EU/1/05/331/001-055

2.9.2009

— Withdrawal of a marketing authorization (Article 13 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

22.8.2008

Protopy

28.8.2008

Quintanrix

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

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

EU/1/02/202/001-006

26.8.2008

EU/1/04/301/001-005

1.9.2008

C 245/20

EN

Official Journal of the European Union

26.9.2008

— 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

13.8.2008

Dexdomitor

22.8.2008

Suvaxyn Aujeszky

Orion Corporation
Orionintie 1
FI-02200 Espoo

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

25.8.2008

Zubrin

25.8.2008

Circovac

25.8.2008

Profender

Schering-Plough Limited
Schering-Plough House
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
United Kingdom

Merial
29, Avenue Tony Garnier
F-69007 Lyon

Bayer HealthCare AG
D-51368 Leverkusen

EU/2/02/033/001-002

15.8.2008

EU/2/98/009/001-006

26.8.2008

EU/2/00/028/002-008

27.8.2008

EU/2/07/075/001-004

27.8.2008

EU/2/05/054/018-031

27.8.2008

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