Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 May 2003 to 15 June 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-07-01
Institutions: European Commission
Subjects: market approval, medicinal product

C 153/2

EN

Official Journal of the European Union

1.7.2003

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 May 2003 to 15 June 2003

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

(2003/C 153/02)

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

27.5.2003

Fuzeon

10.6.2003

Aldurazyme

10.6.2003

Forsteo

Roche Registration Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AY
United Kingdom

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

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

EU/1/03/252/001-003

29.5.2003

EU/1/03/253/001-003

12.6.2003

EU/1/03/247/001-002

12.6.2003

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

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

16.5.2003

Karvezide

16.5.2003

Zerit

16.5.2003

Micardis

19.5.2003

Karvea

19.5.2003

Emadine

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

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

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

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

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

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

EU/1/98/085/001-010

20.5.2003

EU/1/96/009/001-017

20.5.2003

EU/1/98/090/001-014

20.5.2003

EU/1/97/049/001-015

22.5.2003

EU/1/98/095/001-004

22.5.2003

1.7.2003

EN

Official Journal of the European Union

C 153/3

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

19.5.2003

Viramune

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

EU/1/97/055/001-002

22.5.2003

19.5.2003

Viread

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

22.5.2003

19.5.2003

Cancidas

19.5.2003

Fabrazyme

19.5.2003

Sustiva

23.5.2003

Simulect

23.5.2003

Stocrin

4.6.2003

Rebif

4.6.2003

NovoRapid

4.6.2003

NovoRapid

4.6.2003

NovoRapid

4.6.2003

Zometa

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

Genzyme Europe BV
Gooimeer 10
Naarden 1411 DD
Nederland

EU/1/01/196/001-003

22.5.2003

EU/1/01/188/001-006

22.5.2003

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

EU/1/99/110/001-009

22.5.2003

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

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

Serono Europe Ltd
56 Marsh Wall
London E14 9TP
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

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

EU/1/98/084/001-002

28.5.2003

EU/1/99/111/001-009

27.5.2003

EU/1/98/063/001-006

6.6.2003

EU/1/99/119/012-014

6.6.2003

EU/1/99/119/001,
EU/1/99/119/008

6.6.2003

EU/1/99/119/003,
EU/1/99/119/005-007,
EU/1/99/119/009-014

6.6.2003

EU/1/01/176/001-006

6.6.2003

C 153/4

EN

Official Journal of the European Union

1.7.2003

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

4.6.2003

Fasturtec

4.6.2003

Simulect

4.6.2003

Targretin

Sanofi Synthelabo
174, avenue de France
F-75013 Paris

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

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

EU/1/00/170/002

6.6.2003

EU/1/98/084/001-002

6.6.2003

EU/1/01/178/001

6.6.2003

6.6.2003

NovoRapid

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/99/119/001,
EU/1/99/119/003,
EU/1/99/119/005-014

12.6.2003

10.6.2003

InductOs

11.6.2003

Forcaltonin

11.6.2003

Prandin

11.6.2003

Pylobactell

11.6.2003

Combivir

11.6.2003

Panretin

13.6.2003

Aldara

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

Unigene UK Limited
63 High Road
Bushey Heath
Herts WD2 1EE
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Torbet Laboratories Limited
Unit 14D
Wendover Road
Rackheath Industrial Estate
Norwich
Norfolk NR13 6LH
United Kingdom

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

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

3M Santé
Boulevard de l'Oise
F-95029 Cergy Pontoise Cedex

EU/1/02/226/001

12.6.2003

EU/1/98/093/001-002

16.6.2003

EU/1/00/162/001-018

12.6.2003

EU/1/98/064/001

13.6.2003

EU/1/98/058/001-002

13.6.2003

EU/1/00/149/001

13.6.2003

EU/1/98/080/001

18.6.2003

1.7.2003

EN

Official Journal of the European Union

C 153/5

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

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

19.5.2003

Neocolipor

19.5.2003

Clomicalm

Rhône Mérieux (Merial)
17, rue Bourgelat
F-69002 Lyon

Novartis Tiergesundheit GmbH
Industriestraße 30–34
D-65760 Eschborn

19.5.2003

Eurican herpes 205

4.6.2003

Pirsue

4.6.2003

Advocate

4.6.2003

Metacam

Merial
17, rue Bourgelat
F-69002 Lyon

Pharmacia & Upjohn
Rijkweg 12
B-2870 Puurs

Bayer AG
D-51368 Leverkusen

EU/2/98/008/001-004

22.5.2003

EU/2/98/007/001-003

26.5.2003

EU/2/01/029/001-003

22.5.2003

EU/2/00/027/001-003

6.6.2003

EU/2/03/039/001-012

6.6.2003

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/003-005

6.6.2003

— Withdrawal of a marketing authorization (Article 34 of Regulation (EEC) No 2309/93)

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

19.5.2003

Eurifel FelV

Merial
17, rue Bourgelat
F-69002 Lyon

EU/2/00/019/004

22.5.2003

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 Agency for the Evaluation of Medicinal products
7, Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom.