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)
Date: 2007-06-29
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, veterinary drug

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 Ther-
apeutic Chemical
Code)

Date of
notification

2.5.2007

Focetria

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

21.5.2007

ORENCIA

abatacept

24.5.2007

Altargo

retapamulin

Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1
I-53100 Siena

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

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

EU/1/07/385/001-004

Suspension for
tion

injec-

J07BB02

4.5.2007

EU/1/07/389/001-003

Powder for concentrate
for
infu-
solution for
sion

L04AA24

23.5.2007

EU/1/07/390/001-004

Ointment

D06AX13

29.5.2007

(1) OJ L 136 of 30 April 2004, page 1

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C 144/6

EN

Official Journal of the European Union

29.6.2007

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the Euro-

pean Parliament and of the Council): Rejected

Date of the
decision

Name of the
medicinal
product

22.5.2007

Mycograb

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

2.5.2007

Aranesp

2.5.2007

Liprolog

2.5.2007

BeneFIX

2.5.2007

Vfend

2.5.2007

Nespo

2.5.2007

Invirase

2.5.2007

Norvir

2.5.2007

Viramune

2.5.2007

Viread

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

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

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

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

Gilead Sciences International
Limited
Cambridge CB21 6GT
United Kingdom

EU/1/01/185/001-073

4.5.2007

EU/1/01/195/001-015

4.5.2007

EU/1/97/047/001-003

4.5.2007

EU/1/02/212/001-026

4.5.2007

EU/1/01/184/001-073

4.5.2007

EU/1/96/026/001-002

4.5.2007

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

4.5.2007

EU/1/97/055/001-003

4.5.2007

EU/1/01/200/001

4.5.2007

29.6.2007

EN

Official Journal of the European Union

C 144/7

Date of the
decision

Name of the
medicinal
product

2.5.2007

Osigraft

2.5.2007

Sustiva

2.5.2007

Stocrin

3.5.2007

Protopy

3.5.2007

Crixivan

3.5.2007

Protopic

3.5.2007

Infanrix Hexa

3.5.2007

Infanrix Penta

3.5.2007

Humalog

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Howmedica International S. de R.L.
Division of Stryker Corporation
Raheen Industrial Estate
Raheen
Limerick
Ireland

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

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

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

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

Astellas Pharma GmbH
Neumarkter Str. 61
D-81673 München

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

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

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

EU/1/01/179/001

4.5.2007

EU/1/99/110/001-009

4.5.2007

EU/1/99/111/001-011

4.5.2007

EU/1/02/202/001-006

7.5.2007

EU/1/96/024/001-005
EU/1/96/024/007-008
EU/1/96/024/010

8.5.2007

EU/1/02/201/001-006

7.5.2007

EU/1/00/152/001-018

7.5.2007

EU/1/00/153/001-010

7.5.2007

7.5.2007

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

EU/1/04/302/001-004

15.5.2007

11.5.2007

Prialt

Eisai Limited
3, Shortlands
London W6 8EE
United Kingdom

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

C 144/8

EN

Official Journal of the European Union

29.6.2007

Date of the
decision

Name of the
medicinal
product

14.5.2007

Humira

14.5.2007

Trudexa

15.5.2007

Omnitrope

15.5.2007

Iscover

15.5.2007

Plavix

15.5.2007

Xagrid

22.5.2007

Thelin

22.5.2007

Zavesca

22.5.2007

Teslascan

22.5.2007

Opatanol

30.5.2007

Xolair

30.5.2007

Caelyx

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Sandoz GmbH
Biochemiestraße 10
A-Kundl 6250

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

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

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

Encysive (UK) Limited
Alder Castle House
10 Noble Street
London EC2V 7QJ
United Kingdom

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

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

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

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

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

EU/1/03/256/001-010

16.5.2007

EU/1/03/257/001-010

16.5.2007

EU/1/06/332/001-006

18.5.2007

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

17.5.2007

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

21.5.2007

EU/1/04/295/001

17.5.2007

EU/1/06/353/001-005

25.5.2007

EU/1/02/238/001

25.5.2007

EU/1/97/040/001-002

25.5.2007

EU/1/02/217/001-002

24.5.2007

EU/1/05/319/001-004

1.6.2007

EU/1/96/011/001-004

1.6.2007

29.6.2007

EN

Official Journal of the European Union

C 144/9

Date of the
decision

Name of the
medicinal
product

30.5.2007

Ventavis

30.5.2007

Remicade

30.5.2007

LeukoScan

30.5.2007

Ziagen

30.5.2007

Kivexa

30.5.2007

AVANDIA

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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

EU/1/03/255/001-005

1.6.2007

Centocor B.V.
Einsteinweg 101
2333 CB Leiden
Nederland

Immunomedics GmbH
Otto-Röhm-Straße 69
D-64293 Darmstadt

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

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

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

EU/1/99/116/001-003

1.6.2007

EU/1/97/032/001

1.6.2007

EU/1/99/112/001-002

1.6.2007

EU/1/04/298/001-002

1.6.2007

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

31.5.2007

Ketek

31.5.2007

Levviax

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

Aventis Pharma S.A.
20, avenue Raymond Aron
F-92160 Antony

Aventis Pharma S.A.
20, avenue Raymond Aron
F-92160 Antony

EU/1/06/349/001-010

1.6.2007

EU/1/01/191/001-005

4.6.2007

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 Ther-
apeutic Chemical
Code)

Date of
notification

14.5.2007

Nobilis Influ-
enza 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

15.5.2007

METACAM

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of
notification

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 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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