Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2005 to 31 August 2005 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) N° 2309/93)
Date: 2005-09-30
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

30.9.2005

EN

Official Journal of the European Union

C 241/1

I

(Information)

COMMISSION

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 August 2005 to 31 August 2005

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))

(2005/C 241/01)

— Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1))

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

24.08.2005

FOSAVANCE

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

EU/1/05/310/001-005

26.08.2005

— Modification of a marketing authorization (Article 12 of Council Regulation (EEC)

No 2309/93 (1)) 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

01.08.2005

Crixivan

01.08.2005

Humira

01.08.2005

Fabrazyme

01.08.2005

Enbrel

01.08.2005

Trudexa

01.08.2005

Remicade

(1) OJ L 214 of 24.8.1993, p. 1.

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

03.08.2005

Laboratories

Ltd.,
Abbott
Kent
Queenborough,
ME11 5EL, United Kingdom

Genzyme Europe B.V., Goo-
imeer 10, Naarden 1411 DD,
Nederland

Wyeth
Limited,
Europa
Huntercombe Lane South,
Taplow, Maidenhead, Berk-
shire, SL6 0PH, United King-
dom

Laboratories

Ltd.,
Abbott
Queenborough,
Kent
ME11 5EL, United Kingdom

Centocor B.V., Einsteinweg
101, 2333 CB Leiden, Neder-
land

EU/1/03/256/001-006

03.08.2005

EU/1/01/188/001-006

03.08.2005

EU/1/99/126/001-011

03.08.2005

EU/1/03/257/001-006

03.08.2005

EU/1/99/116/001-003

03.08.2005

C 241/2

EN

Official Journal of the European Union

30.9.2005

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

01.08.2005

Fasturtec

01.08.2005

Comtan

01.08.2005

Neulasta

01.08.2005

Neupopeg

09.08.2005

Stocrin

09.08.2005

Sustiva

16.08.2005

Parareg

16.08.2005

NeuroBloc

16.08.2005

MabCampath

16.08.2005

Vivanza

16.08.2005

Dukoral

16.08.2005

Levitra

22.08.2005

Ferriprox

23.08.2005

BeneFIX

24.08.2005

BeneFIX

Sanofi-Aventis, 174, avenue
de France, F-75013 Paris,
France

Novartis Europharm Limited,
Wimblehurst Road, Hor-
sham,
Sussex
West
RH12 5AB, United Kingdom

Amgen Europe B.V., Miner-
vum 7061, NL-4817 ZK
Breda, Nederland

Dompé Biotec S.p.A., Via San
Martino, 12, I – 20122 Mil-
ano, Italia

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

Bristol-Myers Squibb Pharma
EEIG, 141-149 Staines Road,
Hounslow TW3 3JA - United
Kingdom

Dompé Biotec S.p.A., Via San
Martino, 12, I - 20122 Mil-
ano,
Italia Amgen Europe
B.V., Minervum 7061,
NL-4817 ZK Breda, The
Netherlands

Elan Pharma International
Ltd., WIL House, Shannon
Business
Shannon,
Park,
County Clare, Ireland

Genzyme Europe B.V., Goo-
imeer 10, Naarden 1411 DD,
Nederland ILEX Services Lim-
ited, 1 & 3 Frederick Sanger
Road, The Surrey Research
Park,
Surrey,
Guildford
GU2 7YD, United Kingdom

Bayer
AG,
Leverkusen, Deutschland

D-51368

SBL Vaccin AB, S-105 21
Stockholm, Sweden

AG,
Bayer
Leverkusen, Deutschland

D-51368

Apotex Europe Ltd., Rowan
House, 41 London Street,
Reading, Berkshire, RG1 4PS,
United Kingdom

Wyeth Europa Ltd., Hunter-
combe Lane South, Taplow,
Maidenhead,
Berkshire,
SL6 0PH, United Kingdom

Wyeth Europa Ltd., Hunter-
combe Lane South, Taplow,
Maidenhead,
Berkshire,
SL6 0PH, United Kingdom

EU/1/00/170/001-002

03.08.2005

EU/1/98/081/001-004

03.08.2005

EU/1/02/227/001-002

03.08.2005

EU/1/02/228/001-002

03.08.2005

EU/1/99/111/001-009

11.08.2005

EU/1/99/110/001-009

11.08.2005

EU/1/04/293/001-012

18.08.2005

EU/1/00/166/001-003

18.08.2005

EU/1/01/193/001-002

18.08.2005

EU/1/03/249/001-012

18.08.2005

EU/1/03/263/001-003

18.08.2005

EU/1/03/248/001-013

18.08.2005

EU/1/99/108/001

24.08.2005

EU/1/97/047/001-003

25.08.2005

EU/1/97/047/001-003

26.08.2005

30.9.2005

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Official Journal of the European Union

C 241/3

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

24.08.2005

REYATAZ

24.08.2005

Telzir

24.08.2005

Agenerase

24.08.2005

Kaletra

24.08.2005

Fortovase

26.08.2005

Pedea

26.08.2005

Neurobloc

30.08.2005

Stalevo

30.08.2005

Rebetol

31.08.2005

Neulasta

31.08.2005

Renagel

31.08.2005

Avonex

31.08.2005

Avonex

Squibb
- Myers
Bristol
Pharma
141-149
EEIG,
Staines Road, Hounslow
TW3 3JA, United Kingdom

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

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

laboratories

Ltd,
Abbott
Queenborough,
Kent
ME11 5EL, United Kingdom

Roche Registration Limited,
40 Broadwater Road, Wel-
wyn Garden City, Hertford-
shire AL7 3AY, United
Kingdom

Orphan Europe,
‘Le Guillaumet’,
Paris La Défense, France

Immeuble
F-92046

Solstice Neurosciences Ltd,
Fitzwilton House, Wilton
Place, Dublin 2, Ireland Elan
Pharma International Ltd.,
WIL House, Shannon Busi-
ness Park, Shannon, County
Clare, Ireland

Orion Corporation, Orionin-
tie 1, FIN-02200 Espoo,
Suomi

Schering Plough Europe, Rue
de Stalle, 73, 1180 Bruxelles,
Belgique – Stallestraat, 73 –
1180 Brussel, België

Amgen Europe B.V., Miner-
vum 7061, NL-4817 ZK
Breda, Nederland

Genzyme Europe B.V., Goo-
imeer 10, Naarden 1411 DD,
Nederland

Biogen Idec Ltd, 5 Roxbor-
ough Way, Foundation Park,
Berkshire,
Maidenhead,
SL6 3UD, United Kindgom

Biogen Idec Ltd, 5 Roxbor-
ough Way, Foundation Park,
Berkshire,
Maidenhead,
SL6 3UD, United Kindgom

EU/1/03/267/001-007

26.08.2005

EU/1/04/282/001-002

26.08.2005

EU/1/00/148/001-004

26.08.2005

EU/1/01/172/001-003

26.08.2005

EU/1/98/075/001-002

26.08.2005

EU/1/04/284/001

31.08.2005

EU/1/00/166/001-003

01.09.2005

EU/1/03/260/001-012

01.09.2005

EU/1/99/107/001-003

01.09.2005

EU/1/02/227/001-002

02.09.2005

EU/1/99/123/001-011

05.09.2005

EU/1/97/033/001-003

02.09.2005

EU/1/97/033/001-003

02.09.2005

31.08.2005

Norvir

laboratories

Ltd,
Abbott
Queenborough,
Kent
ME11 5EL, United-Kingdom

EU/1/96/016/001
EU/1/96/016/003

02.09.2005

C 241/4

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Official Journal of the European Union

30.9.2005

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

31.08.2005

Neupopeg

31.08.2005

Invirase

31.08.2005

Zerit

31.08.2005

Zyprexa

Dompé Biotec S.p.A., Via San
Martino, 12, I – 20122 Mil-
ano, Italia

Roche Registration Ltd., 40,
Broadwater Road, Welwyn
Garden City, Hertfordshire,
AL7 3AY, United Kingdom

Bristol-Myers Squibb Pharma
EEIG, 141-149 Staines Road,
Hounslow TW3 3JA - United
Kingdom

BV,
Lilly Nederland
Eli
Grootslag 1-5, 3991 RA
Houten, Nederland

EU/1/02/228/001-002

02.09.2005

EU/1/96/026/001-002

02.09.2005

EU/1/96/009/001-017

02.09.2005

02.09.2005

EU/1/96/022/002,
EU/1/96/022/004,
EU/1/96/022/006,
EU/1/96/022/008-012,
EU/1/96/022/014
EU/1/96/022/016-022

31.08.2005

Zyprexa Velotab

Eli
BV,
Lilly Nederland
Grootslag 1-5, 3991 RA
Houten, Nederland

EU/1/99/125/001-008

02.09.2005

— Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1))

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

09.08.2005

Tenecteplase Boe-
hringer Ingelheim
Pharma GmbH co.
KG

Boehringer Ingelheim Inter-
national
Binger
GmbH,
Strasse 173, D-55216 Ingel-
heim am Rhein, Deutschland

EU/1/00/168/001-006

11.08.2005

— Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93 (1))

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

01.08.2005

Metacam

18.08.2005

Quadrisol

18.08.2005

Pirsue

25.08.2005

Novem

26.08.2005

Virbagen omega

(1) OJ L 214 of 24.8.1993, p. 1.

Boehringer Ingelheim Vet-
medica GmbH, 55216
Ingelheim am Rhein, Deut-
schland

Intervet International B.V.,
Wim de Körverstraat 35,
5831 AN Boxmeer, Neder-
land

PFIZER Ltd, Ramsgate
Road, Sandwich, Kent CT
13 9NJ, United Kingdom

Boehringer Ingelheim Vet-
medica GmbH, 55216
Ingelheim am Rhein, Deut-
schland

VIRBAC S.A., 1ere Avenue
2065 m L.I.D.
- 06516
Carros - France

EU/2/97/004/012-013

03.08.2005

EU/2/97/005/001-003
EU/2/97/005/005-009

22.08.2005

EU/2/00/027/001-003

22.08.2005

EU/2/04/042/001-002

29.08.2005

EU/2/01/030/001-004

31.08.2005

30.9.2005

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Official Journal of the European Union

C 241/5

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
UK - LONDON E14 4HB