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Document 52008XC0926(02)

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 )

OJ C 245, 26.9.2008, p. 15–20 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

26.9.2008   

EN

Official Journal of the European Union

C 245/15

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)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

28.8.2008

INTELENCE

Etravirine

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/08/468/001

Tablet

(Non applicable)

1.9.2008

29.8.2008

Vimpat

Lacosamide

UCB S.A.

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/B-1070 Brussel

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

—   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

Schwarz Pharma Ltd

Shannon

Industrial Estate

Co.Clare

Ireland

EU/1/05/331/001-037

6.8.2008

8.8.2008

Champix

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/360/001-012

12.8.2008

8.8.2008

Vectibix

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/073/001-004

12.8.2008

8.8.2008

Avandamet

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/03/258/001-022

12.8.2008

11.8.2008

Optruma

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/98/074/001-004

13.8.2008

13.8.2008

Silapo

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

EU/1/07/432/001-022

15.8.2008

13.8.2008

Retacrit

HOSPIRA Enterprises B.V.

Taurusavenue 19-21b

2132 LS Hoofddorp

Nederland

EU/1/07/431/001-019

15.8.2008

13.8.2008

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

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

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/00/153/001-010

18.8.2008

13.8.2008

Cervarix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/07/419/001-009

18.8.2008

22.8.2008

Evista

DAIICHI SANKYO EUROPE GmbH

Zielstattstrasse 48

D-81379 München

EU/1/98/073/001-004

26.8.2008

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

22.8.2008

Kaletra

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/01/172/001-006

26.8.2008

22.8.2008

Baraclude

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/06/343/001-007

26.8.2008

22.8.2008

SUTENT

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-006

26.8.2008

22.8.2008

Fosavance

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/05/310/001-009

26.8.2008

22.8.2008

Zalasta

KRKA d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

EU/1/07/415/001-056

26.8.2008

22.8.2008

Arixtra

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/206/001-035

26.8.2008

22.8.2008

Revlimid

Celgene Europe Limited

Morgan House

Madeira Walk

Windsor

Berkshire SL4 1EP

United Kingdom

EU/1/07/391/001-004

26.8.2008

25.8.2008

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex UB8 1HU

United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

27.8.2008

25.8.2008

TARGRETIN

Eisai Limited

3 Shortlands

London W6 8EE

United Kingdom

EU/1/01/178/001

27.8.2008

25.8.2008

Emselex

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/04/294/001-028

27.8.2008

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

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

27.8.2008

25.8.2008

Revatio

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/05/318/001

27.8.2008

25.8.2008

Prialt

Eisai Limited

3 Shortlands

London W6 8EE

United Kingdom

EU/1/04/302/001-004

27.8.2008

25.8.2008

NovoSeven

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-006

27.8.2008

26.8.2008

Viagra

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/98/077/002-004

EU/1/98/077/006-008

EU/1/98/077/010-019

28.8.2008

28.8.2008

Rasilez

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/405/001-020

1.9.2008

28.8.2008

Tekturna

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/408/001-020

1.9.2008

28.8.2008

Raptiva

Serono Europe Limited

56 Marsh Wall

London E14 9TP

United Kingdom

EU/1/04/291/001-003

1.9.2008

28.8.2008

ISENTRESS

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/07/436/001-002

1.9.2008

28.8.2008

Enviage

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/406/001-020

1.9.2008

28.8.2008

Sprimeo

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/407/001-020

1.9.2008

28.8.2008

Riprazo

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/409/001-020

1.9.2008

29.8.2008

Avastin

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/04/300/001-002

2.9.2008

29.8.2008

Nespo

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/01/184/001-073

2.9.2008

29.8.2008

Enbrel

Wyeth Europa Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/001-018

1.9.2008

29.8.2008

Velcade

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/04/274/001-002

2.9.2009

29.8.2008

Humira

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

2.9.2009

29.8.2008

Prezista

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

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

Schwarz Pharma Ltd

Shannon Industrial Estate

Co.Clare

Ireland

EU/1/05/331/038-055

2.9.2009

29.8.2008

Neupro

Schwarz Pharma Ltd

Shannon Industrial Estate

Co.Clare

Ireland

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

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/202/001-006

26.8.2008

28.8.2008

Quintanrix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/04/301/001-005

1.9.2008

—   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

Orion Corporation

Orionintie 1

FI-02200 Espoo

EU/2/02/033/001-002

15.8.2008

22.8.2008

Suvaxyn Aujeszky

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

Nederland

EU/2/98/009/001-006

26.8.2008

25.8.2008

Zubrin

Schering-Plough Limited

Schering-Plough House

Shire Park

Welwyn Garden City

Hertfordshire AL7 1TW

United Kingdom

EU/2/00/028/002-008

27.8.2008

25.8.2008

Circovac

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/07/075/001-004

27.8.2008

25.8.2008

Profender

Bayer HealthCare AG

D-51368 Leverkusen

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 decisions relating thereto is invited to contact:

The European Medicines Agency

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

(1)  OJ L 136, 30.4.2004, p. 1.

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