Summary of Community decisions on marketing authorisations in respect of medicinal products for the period 15 November 2004 to 15 December 2004(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-12-24
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

24.12.2004

EN

Official Journal of the European Union

C 320/23

Summary of Community decisions on marketing authorisations in respect of medicinal products
for the period 15 November 2004 to 15 December 2004

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

(2004/C 320/13)

— Issuing of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93): accepted

Date of the
decision

Name of the
medicinal
product

16.11.2004

Xagrid

Holder of the marketing authorisation

Shire Pharmaceutical Contracts Ltd,
Hampshire
Business
Park, Chineham, Basingstoke, Hamp-
shire RG24 8EP, United Kingdom

International

Number of the entry
in the Community
Register

Date of
notification

EU/1/04/295/001

18.11.2004

— Modification of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93):

accepted

Date of the
decision

Name of the
medicinal
product

16.11.2004

Tamiflu

17.11.2004

Trizivir

17.11.2004

Targretin

25.11.2004

Bextra

Holder of the marketing authorisation

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City,
Hertfordshire, AL7
3AY, United
Kingdom

Number of the entry
in the Community
Register

Date of
notification

EU/1/02/222/001

18.11.2004

Glaxo
Greenford,
Middlesex, UB6 0NN, United Kingdom

Group

Ltd,

Pharmaceuticals UK

Ligand
Ltd,
Innovis House, 108 High Street,
Crawley, West Sussex, RH10 1BB,
United Kingdom

Pharmacia-Pfizer
Kent, CT13 9NJ, United Kingdom

EEIG,

Sandwich,

EU/1/00/156/001-
003

19.11.2004

EU/1/01/178/001

19.11.2004

EU/1/02/239/001-
024

29.11.2004

25.11.2004

ReFacto

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

EU/1/99/103/001-
004

29.11.2004

30.11.2004

Xigris

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

EU/1/02/225/001-
002

2.12.2004

30.11.2004

Tracleer

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

EU/1/02/220/001-
005

2.12.2004

30.11.2004

Cialis

Lilly ICOS Limited, St Bride's House,
10 Salisbury Square, London, EC4Y
8EH, United Kingdom

EU/1/02/237/001
EU/1/02/237/005

2.12.2004

1.12.2004

Micardis

Boehringer
Ingelheim International
GmbH, Binger Strasse 173, D-55216
Ingelheim am Rhein

EU/1/98/090/001-
014

3.12.2004

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

C 320/24

EN

Official Journal of the European Union

24.12.2004

Date of the
decision

Name of the
medicinal
product

6.12.2004

Integrilin

Number of the entry
in the Community
Register

Date of
notification

EU/1/99/109/001-
002

8.12.2004

Holder of the marketing authorisation

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

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

6.12.2004

Epivir

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

EU/1/96/015/001-
005

8.12.2004

6.12.2004

Dynastat

Pharmacia Europe EEIG, Sandwich,
Kent, CT13 9NJ, United Kingdom

EU/1/02/209/001-
008

8.12.2004

6.12.2004

Sustiva

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

EU/1/99/110/001-
009

8.12.2004

6.12.2004

NutropinAq

IPSEN Limited,
190 Bath Road,
Slough, Berkshire, SLI 3XE, United
Kingdom

EU/1/00/164/001-
005

8.12.2004

6.12.2004

Strocrin

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

EU/1/99/111/001-
009

8.12.2004

6.12.2004

Dynastat

Pharmacia Europe EEIG, Sandwich,
Kent, CT13 9NJ, United Kingdom

EU/1/02/209/001-
008

8.12.2004

6.12.2004

Panretin

Pharmaceuticals UK

Ligand
Ltd,
Innovis House, 108 High Street,
Crawley, West Sussex, RH10 1BB,
United Kingdom

EU/1/00/149/001

8.12.2004

6.12.2004

Arava

Aventis Pharma Deutschland GmbH,
D-65926 Frankfurt am Main

EU/1/99/118/001-
010

8.12.2004

6.12.2004

Viread

Gilead Sciences International Limited,
Cambridge, CB1 6GT United Kingdom

EU/1/01/200/001

8.12.2004

6.12.2004

Rayzon

Pharmacia Europe EEIG, Sandwich,
Kent, CT13 9NJ, United Kingdom

EU/1/02/210/001-
008

8.12.2004

6.12.2004

Rayzon 6m

Pharmacia Europe EEIG, Sandwich,
Kent, CT13 9NJ, United Kingdom

EU/1/02/210/001-
008

8.12.2004

7.12.2004

Kinzalmono

Bayer AG, D-51368 Leverkusen

EU/1/98/091/001-
014

9.12.2004

7.12.2004

Micardis

Boehringer
Ingelheim International
GmbH, Binger Strasse 173, D-55216
Ingelheim am Rhein

EU/1/98/090/001-
014

10.12.2004

7.12.2004

Pritor

Greenford,
Glaxo
Middlesex, UB6 0NN, United Kingdom

Group

Ltd,

EU/1/98/089/001-
016

9.12.2004

24.12.2004

EN

Official Journal of the European Union

C 320/25

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

Date of the
decision

Name of the
medicinal
product

8.12.2004

Venvia

Holder of the marketing authorisation

Number of the entry
in the Community
Register

Date of
notification

SmithKline Beecham plc, New Hori-
zons Court, Brentford, Middlesex,
United Kingdom TW8 9EP

EU/1/00/138/001-
012

10.12.2004

7.12.2004

Nyracta

SmithKline Beecham plc, New Hori-
zons Court, Brentford, Middlesex,
United Kingdom TW8 9EP

EU/1/00/139/001-
012

9.12.2004

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

accepted

Date of the
decision

Name of the
medicinal
product

25.11.2004

Nobivac Bb

25.11.2004

Halocur

Holder of the marketing authorization

Intervet
International BV, Wim de
Körverstraat 35, 5831 AN Boxmeer,
Nederland

Intervet
International BV, Wim de
Körverstraat 35, 5831 AN Boxmeer,
Nederland

Number of the entry
in the Community
Register

Date of
notification

EU/2/02/034/001

29.11.2004

EU/2/99/013/001-
002

29.11.2004

7.12.2004

Stronghold

Pfizer Ltd, Ramsgate Road, Sandwich,
Kent, CT13 9NJ, United Kingdom

EU/2/99/014/001-
012

10.12.2004

7.12.2004

Oxyglobin

Biopure Netherlands
Prinses
Irenestraat 59, 1077 WV Amsterdam,
Nederland

BV,

EU/2/99/015/001

9.12.2004