29.6.2007   

EN

Official Journal of the European Union

C 144/5

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 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 144/06)

—   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-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

2.5.2007

Focetria

A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1

I-53100 Siena

EU/1/07/385/001-004

Suspension for injection

J07BB02

4.5.2007

21.5.2007

ORENCIA

abatacept

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/07/389/001-003

Powder for concentrate for solution for infusion

L04AA24

23.5.2007

24.5.2007

Altargo

retapamulin

Glaxo Group Ltd.

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/07/390/001-004

Ointment

D06AX13

29.5.2007

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

22.5.2007

Mycograb

NeuTec Pharma plc

Central Manchester & Manchester Children's Hospital NHS Trust

Oxford Rd

Manchester M13 9WL

United Kingdom

—

29.5.2007

—   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

2.5.2007

Aranesp

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/01/185/001-073

4.5.2007

2.5.2007

Liprolog

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/01/195/001-015

4.5.2007

2.5.2007

BeneFIX

Wyeth Europa Ltd.

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/97/047/001-003

4.5.2007

2.5.2007

Vfend

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/02/212/001-026

4.5.2007

2.5.2007

Nespo

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/01/184/001-073

4.5.2007

2.5.2007

Invirase

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/96/026/001-002

4.5.2007

2.5.2007

Norvir

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

4.5.2007

2.5.2007

Viramune

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/055/001-003

4.5.2007

2.5.2007

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/01/200/001

4.5.2007

2.5.2007

Osigraft

Howmedica International S. de R.L.

Division of Stryker Corporation

Raheen Industrial Estate

Raheen

Limerick

Ireland

EU/1/01/179/001

4.5.2007

2.5.2007

Sustiva

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/99/110/001-009

4.5.2007

2.5.2007

Stocrin

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/99/111/001-011

4.5.2007

3.5.2007

Protopy

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/202/001-006

7.5.2007

3.5.2007

Crixivan

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/96/024/001-005

EU/1/96/024/007-008

EU/1/96/024/010

8.5.2007

3.5.2007

Protopic

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

EU/1/02/201/001-006

7.5.2007

3.5.2007

Infanrix Hexa

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/00/152/001-018

7.5.2007

3.5.2007

Infanrix Penta

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

B-1330 Rixensart

EU/1/00/153/001-010

7.5.2007

3.5.2007

Humalog

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/96/007/002

EU/1/96/007/004-006

EU/1/96/007/008

EU/1/96/007/010-011

EU/1/96/007/015-021

EU/1/96/007/023-030

7.5.2007

11.5.2007

Prialt

Eisai Limited

3, Shortlands

London W6 8EE

United Kingdom

EU/1/04/302/001-004

15.5.2007

14.5.2007

PritorPlus

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/02/215/001-014

16.5.2007

14.5.2007

Hepsera

Gilead Sciences International Limited

Granta Park Abington

Cambridge CB1 6GT

United Kingdom

EU/1/03/251/001-002

16.5.2007

14.5.2007

Humira

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/256/001-010

16.5.2007

14.5.2007

Trudexa

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/03/257/001-010

16.5.2007

15.5.2007

Omnitrope

Sandoz GmbH

Biochemiestraße 10

A-Kundl 6250

EU/1/06/332/001-006

18.5.2007

15.5.2007

Iscover

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/98/070/001a–006a

EU/1/98/070/001b-006b

17.5.2007

15.5.2007

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/98/069/001a-006a

EU/1/98/069/001b-006b

21.5.2007

15.5.2007

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

EU/1/04/295/001

17.5.2007

22.5.2007

Thelin

Encysive (UK) Limited

Alder Castle House

10 Noble Street

London EC2V 7QJ

United Kingdom

EU/1/06/353/001-005

25.5.2007

22.5.2007

Zavesca

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

EU/1/02/238/001

25.5.2007

22.5.2007

Teslascan

GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen

N-0401 Oslo

EU/1/97/040/001-002

25.5.2007

22.5.2007

Opatanol

Alcon Laboratories (UK) Ltd.

Pentagon Park

Boundary Way

Hemel Hempstead

Herts HP2 7UD

United Kingdom

EU/1/02/217/001-002

24.5.2007

30.5.2007

Xolair

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/05/319/001-004

1.6.2007

30.5.2007

Caelyx

Schering Plough Europe

rue de Stalle, 73

B-1180 Bruxelles

Stallestraat, 73

B-1180 Brussel

EU/1/96/011/001-004

1.6.2007

30.5.2007

Ventavis

Bayer Schering Pharma AG

Müllerstraße 170-178

D-13342 Berlin

EU/1/03/255/001-005

1.6.2007

30.5.2007

Remicade

Centocor B.V.

Einsteinweg 101

2333 CB Leiden

Nederland

EU/1/99/116/001-003

1.6.2007

30.5.2007

LeukoScan

Immunomedics GmbH

Otto-Röhm-Straße 69

D-64293 Darmstadt

EU/1/97/032/001

1.6.2007

30.5.2007

Ziagen

Glaxo Group Ltd.

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/99/112/001-002

1.6.2007

30.5.2007

Kivexa

Glaxo Group Ltd.

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/298/001-002

1.6.2007

30.5.2007

AVANDIA

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/00/137/002-018

1.6.2007

30.5.2007

Viramune

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/055/001-003

1.6.2007

30.5.2007

Avaglim

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

EU/1/06/349/001-010

1.6.2007

31.5.2007

Ketek

Aventis Pharma S.A.

20, avenue Raymond Aron

F-92160 Antony

EU/1/01/191/001-005

4.6.2007

31.5.2007

Levviax

Aventis Pharma S.A.

20, avenue Raymond Aron

F-92160 Antony

EU/1/01/192/001-005

5.6.2007

—   Issuing 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

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

14.5.2007

Nobilis Influenza H7N1

Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of ≥ 6,0 log2 as tested according to the potency test.

Intervet International B.V.

EU/2/07/073/001-004

Emulsion for injection

QI01AA23

16.5.2007

—   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

15.5.2007

METACAM

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein

EU/2/97/004/007-008

EU/2/97/004/014-015

EU/2/97/004/027-028

18.5.2007

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 of 30 April 2004, page 1