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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 Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorization
decision product Community Register notification

27.5.2003 Fuzeon Roche Registration Limited EU/1/03/252/001-003 29.5.2003


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

10.6.2003 Aldurazyme Genzyme Europe BV EU/1/03/253/001-003 12.6.2003


Gooimeer 10
1411 DD Naarden
Nederland

10.6.2003 Forsteo Eli Lilly Nederland BV EU/1/03/247/001-002 12.6.2003


Grootslag 1-5
3991 RA Houten
Nederland

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


Accepted

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorization
decision product Community Register notification

16.5.2003 Karvezide Bristol-Myers Squibb Pharma EEIG EU/1/98/085/001-010 20.5.2003


141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

16.5.2003 Zerit Bristol-Myers Squibb Pharma EEIG EU/1/96/009/001-017 20.5.2003


141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

16.5.2003 Micardis Boehringer Ingelheim International EU/1/98/090/001-014 20.5.2003


GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

19.5.2003 Karvea Bristol-Myers Squibb Pharma EEIG EU/1/97/049/001-015 22.5.2003


141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

19.5.2003 Emadine Alcon Laboratories (UK) Ltd EU/1/98/095/001-004 22.5.2003


Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom

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


1.7.2003 EN Official Journal of the European Union C 153/3

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorization
decision product Community Register notification

19.5.2003 Viramune Boehringer Ingelheim International EU/1/97/055/001-002 22.5.2003


GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

19.5.2003 Viread Gilead Sciences International Limited EU/1/01/200/001 22.5.2003


Cambridge CB1 6GT
United Kingdom

19.5.2003 Cancidas Merck Sharp & Dohme Ltd EU/1/01/196/001-003 22.5.2003


Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

19.5.2003 Fabrazyme Genzyme Europe BV EU/1/01/188/001-006 22.5.2003


Gooimeer 10
Naarden 1411 DD
Nederland

19.5.2003 Sustiva Bristol-Myers Squibb Pharma EEIG EU/1/99/110/001-009 22.5.2003


141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

23.5.2003 Simulect Novartis Europharm Limited EU/1/98/084/001-002 28.5.2003


Wimblehurst Road
Horsham
West Sussex RH12 5AB
United Kingdom

23.5.2003 Stocrin Merck Sharp & Dohme Ltd EU/1/99/111/001-009 27.5.2003


Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

4.6.2003 Rebif Serono Europe Ltd EU/1/98/063/001-006 6.6.2003


56 Marsh Wall
London E14 9TP
United Kingdom

4.6.2003 NovoRapid Novo Nordisk A/S EU/1/99/119/012-014 6.6.2003


Novo Allé
DK-2880 Bagsværd

4.6.2003 NovoRapid Novo Nordisk A/S EU/1/99/119/001, 6.6.2003


Novo Allé EU/1/99/119/008
DK-2880 Bagsværd

4.6.2003 NovoRapid Novo Nordisk A/S EU/1/99/119/003, 6.6.2003


Novo Allé EU/1/99/119/005-007,
DK-2880 Bagsværd EU/1/99/119/009-014

4.6.2003 Zometa Novartis Europharm Limited EU/1/01/176/001-006 6.6.2003


Wimblehurst Road
Horsham
West Sussex RH12 5AB
United Kingdom
C 153/4 EN Official Journal of the European Union 1.7.2003

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorization
decision product Community Register notification

4.6.2003 Fasturtec Sanofi Synthelabo EU/1/00/170/002 6.6.2003


174, avenue de France
F-75013 Paris

4.6.2003 Simulect Novartis Europharm Limited EU/1/98/084/001-002 6.6.2003


Wimblehurst Road
Horsham
West Sussex RH12 5AB
United Kingdom

4.6.2003 Targretin Ligand Pharmaceuticals UK Ltd EU/1/01/178/001 6.6.2003


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

6.6.2003 NovoRapid Novo Nordisk A/S EU/1/99/119/001, 12.6.2003


Novo Allé EU/1/99/119/003,
DK-2880 Bagsværd EU/1/99/119/005-014

10.6.2003 InductOs Wyeth Europa Ltd EU/1/02/226/001 12.6.2003


Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

11.6.2003 Forcaltonin Unigene UK Limited EU/1/98/093/001-002 16.6.2003


63 High Road
Bushey Heath
Herts WD2 1EE
United Kingdom

11.6.2003 Prandin Novo Nordisk A/S EU/1/00/162/001-018 12.6.2003


Novo Allé
DK-2880 Bagsværd

11.6.2003 Pylobactell Torbet Laboratories Limited EU/1/98/064/001 13.6.2003


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

11.6.2003 Combivir Glaxo Group Ltd EU/1/98/058/001-002 13.6.2003


Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

11.6.2003 Panretin Ligand Pharmaceuticals UK Ltd EU/1/00/149/001 13.6.2003


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

13.6.2003 Aldara 3M Santé EU/1/98/080/001 18.6.2003


Boulevard de l'Oise
F-95029 Cergy Pontoise Cedex
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 Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorization
decision product Community Register notification

19.5.2003 Neocolipor Rhône Mérieux (Merial) EU/2/98/008/001-004 22.5.2003


17, rue Bourgelat
F-69002 Lyon

19.5.2003 Clomicalm Novartis Tiergesundheit GmbH EU/2/98/007/001-003 26.5.2003


Industriestraße 30–34
D-65760 Eschborn

19.5.2003 Eurican herpes 205 Merial EU/2/01/029/001-003 22.5.2003


17, rue Bourgelat
F-69002 Lyon

4.6.2003 Pirsue Pharmacia & Upjohn EU/2/00/027/001-003 6.6.2003


Rijkweg 12
B-2870 Puurs

4.6.2003 Advocate Bayer AG EU/2/03/039/001-012 6.6.2003


D-51368 Leverkusen

4.6.2003 Metacam Boehringer Ingelheim Vetmedica EU/2/97/004/003-005 6.6.2003


GmbH
D-55216 Ingelheim am Rhein

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

Date of the Name of the medicinal Number of the entry in the Date of
Holder of the marketing authorization
decision product Community Register notification

19.5.2003 Eurifel FelV Merial EU/2/00/019/004 22.5.2003


17, rue Bourgelat
F-69002 Lyon

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.