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C 53/2 EN Official Journal of the European Communities 20.2.

2001

Summary of Community decisions on marketing authorisations in respect of medicinal products

from 15 January to 15 February 2001

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

(2001/C 53/02)

— Issuing of a marketing authorisation (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 authorisation
decision product Community Register notification

22.1.2001 Neurobloc Elan Pharma International Ltd EU/1/00/166/001-003 25.1.2001


WIL House
Shannon Business Park
Shannon
County Clare
Ireland

29.1.2001 Prandin Novo Nordisk A/S EU/1/00/162/001-018 31.1.2001


Novo AllØ
DK-2880 Bagsværd

2.2.2001 Xeloda Roche Registration Limited EU/1/00/163/001-002 6.2.2001


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

2.2.2001 Prevenar Wyeth-Lederle Vaccines SA EU/1/00/167/001-004 6.2.2001


Rue du Bosquet 15
B-1348 Louvain-la-Neuve

2.2.2001 Ovidrelle Ares Serono (Europe) Ltd EU/1/00/165/001-006 6.2.2001


24 Gilbert Street
London W1Y 1RJ
United Kingdom

— Modification of a marketing authorisation (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 authorisation
decision product Community Register notification

15.1.2001 Novorapid Novo Nordisk A/S EU/1/99/119/001-008 23.1.2001


Novo AllØ
DK-2880 Bagsværd

22.1.2001 Fortovase Roche Registration Limited EU/1/98/075/001-002 24.1.2001


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

22.1.2001 Epivir Glaxo Group Ltd EU/1/96/015/001-002 23.1.2001


Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

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


20.2.2001 EN Official Journal of the European Communities C 53/3

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

22.1.2001 Zerit Bristol-Myers Squibb Pharma EEIG EU/1/96/009/001-009 23.1.2001


Swakeleys House
Milton Road
Ickenham UB10 8PU
United Kingdom

22.1.2001 Novonorm Novo Nordisk A/S EU/1/98/076/001-002, 23.1.2001


Novo AllØ 004-009, 011-016,
DK-2880 Bagsværd 018-021

22.1.2001 Novomix 30 Novo Nordisk A/S EU/1/00/142/003-008 23.1.2001


Novo AllØ
DK-2880 Bagsværd

22.1.2001 Telmisartan Boehringer Ingelheim International EU/1/98/091/001-012 24.1.2001


Boehringer Ingelheim GmbH
Pharma KG Binger Straße 173
D-55218 Ingelheim am Rhein

22.1.2001 Revasc Aventis Pharma SA EU/1/97/043/001-002 24.1.2001


20, avenue Raymond-Aron
F-92165 Antony Cedex

22.1.2001 Avonex Biogen France SA EU/1/97/033/002 24.1.2001


55, avenue des Champs-Pierreux
F-92012 Nanterre Cedex

22.1.2001 Micardis Boehringer Ingelheim International EU/1/98/090/001-012 24.1.2001


GmbH
Binger Straße 173
D-55218 Ingelheim am Rhein

22.1.2001 Rebif Ares Serono (Europe) Ltd EU/1/98/063/001-006 24.1.2001


24 Gilbert Street
London W1Y 1RJ
United Kingdom

29.1.2001 Novomix 30 Novo Nordisk A/S EU/1/00/142/001-008 31.1.2001


Novo AllØ
DK-2880 Bagsværd

29.1.2001 Remicade Centocor BV EU/1/99/116/001-003 31.1.2001


Einsteinweg 101
2333 CB Leiden
Nederland

29.1.2001 Betaferon Schering AG EU/1/95/003/001-004 30.1.2001


D-13342 Berlin

29.1.2001 Gonal F Ares Serono (Europe) Ltd EU/1/95/001/021 30.1.2001


24 Gilbert Street
London W1Y 1RJ
United Kingdom
C 53/4 EN Official Journal of the European Communities 20.2.2001

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

29.1.2001 Cystagon Orphan Europe SARL EU/1/97/039/001-004 30.1.2001


Immeuble ‘Le Guillaumet’
60, avenue du PrØsident-Wilson
F-92046 Paris-La DØfense

2.2.2001 Pritor Glaxo Group Ltd EU/1/98/089/001-014 6.2.2001


Greenford
Middlesex UB6 0NN
United Kingdom

6.2.2001 Lantus Aventis Pharma Deutschland GmbH EU/1/00/134/001-007 7.2.2001


Brüningstraße 50
D-65926 Frankfurt am Main

— Withdrawal of a marketing authorisation (Article 12 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 authorisation
decision product Community Register notification

22.1.2001 Echogen Sonus Pharmaceuticals Ltd EU/1/98/072/001 24.1.2001


Knyvett House
The Causeway
Staines
Middlesex TW18 3BA
United Kingdom

22.1.2001 Rotashield Wyeth-Lederle Vaccines SA EU/1/99/105/001 24.1.2001


Rue du Bosquet 15
B-1348 Louvain-la-Neuve

29.1.2001 Novonorm Novo Nordisk A/S EU/1/98/076/003, 010, 017 31.1.2001


Novo AllØ
DK-2880 Bagsværd

— Suspension of a marketing authorisation (Article 12 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 authorisation
decision product Community Register notification

29.1.2001 Tasmar Roche Registration Ltd EU/1/97/044/001-006 31.1.2001


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

— Issuing of a marketing authorisation (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 authorisation
decision product Community Register notification

2.2.2001 Bayovac CSF E2 Bayer AG EU/2/00/025/001-004 6.2.2001


Geschäftsbereich Tiergesundheit
D-51368 Leverkusen
20.2.2001 EN Official Journal of the European Communities C 53/5

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

29.1.2001 Pirsue Pharmacia & Upjohn EU/2/00/027/001-003 31.1.2001


Rijkweg 12
B-2870 Puurs

— Modification of a marketing authorisation (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 authorisation
decision product Community Register notification

2.2.2001 Stronghold Pfizer Ltd EU/2/99/014/001-011 6.2.2001


Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

6.2.2001 Econor Novartis Animal EU/2/98/010/023-024 7.2.2001


Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl

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

Summary of Community decisions on marketing authorisations in respect of medicinal products


from 15 January to 15 February 2001

(Decisions taken pursuant to Article 14 of Directive 75/319/EEC (1) or Article 22 of Directive 81/851/EEC (2))

(2001/C 53/03)

— Modification of a national marketing authorisation

Date of the Name(s) of the medicinal Date of


Holder(s) of the marketing authorisation Member State concerned
decision product notification

6.2.2001 Glucophage See Annex See Annex 6.6.2001

(1) OJ L 147, 9.6.1975, p. 13; as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
(2) OJ L 317, 6.11.1981, p. 1; as last amended by Directive 93/40/EEC (OJ L 214, 24.8.1993, p. 31).