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)
Date: 2001-02-20
Institutions: European Commission
Subjects: EU Member State, marketing, marketing standard, medicinal product

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)

(cid:151) Issuing of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93): Accepted

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

22.1.2001

Neurobloc

29.1.2001

Prandin

2.2.2001

Xeloda

2.2.2001

Prevenar

2.2.2001

Ovidrelle

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

Novo Nordisk A/S
Novo AllØ
DK-2880 Bagsv(cid:230)rd

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

Wyeth-Lederle Vaccines SA
Rue du Bosquet 15
B-1348 Louvain-la-Neuve

Ares Serono (Europe) Ltd
24 Gilbert Street
London W1Y 1RJ
United Kingdom

EU/1/00/166/001-003

25.1.2001

EU/1/00/162/001-018

31.1.2001

EU/1/00/163/001-002

6.2.2001

EU/1/00/167/001-004

6.2.2001

EU/1/00/165/001-006

6.2.2001

(cid:151) Modification of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

15.1.2001

Novorapid

22.1.2001

Fortovase

22.1.2001

Epivir

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

Novo Nordisk A/S
Novo AllØ
DK-2880 Bagsv(cid:230)rd

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

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

EU/1/99/119/001-008

23.1.2001

EU/1/98/075/001-002

24.1.2001

EU/1/96/015/001-002

23.1.2001

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Official Journal of the European Communities

C 53/3

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

22.1.2001

Zerit

Bristol-Myers Squibb Pharma EEIG
Swakeleys House
Milton Road
Ickenham UB10 8PU
United Kingdom

EU/1/96/009/001-009

23.1.2001

22.1.2001

Novonorm

22.1.2001

Novomix 30

Novo Nordisk A/S
Novo AllØ
DK-2880 Bagsv(cid:230)rd

Novo Nordisk A/S
Novo AllØ
DK-2880 Bagsv(cid:230)rd

EU/1/98/076/001-002,
004-009, 011-016,
018-021

23.1.2001

EU/1/00/142/003-008

23.1.2001

22.1.2001

Telmisartan
Boehringer Ingelheim
Pharma KG

Boehringer Ingelheim International
GmbH
Binger Stra(cid:223)e 173
D-55218 Ingelheim am Rhein

EU/1/98/091/001-012

24.1.2001

22.1.2001

Revasc

Aventis Pharma SA
20, avenue Raymond-Aron
F-92165 Antony Cedex

EU/1/97/043/001-002

24.1.2001

22.1.2001

Avonex

Biogen France SA
55, avenue des Champs-Pierreux
F-92012 Nanterre Cedex

EU/1/97/033/002

24.1.2001

22.1.2001

Micardis

Boehringer Ingelheim International
GmbH
Binger Stra(cid:223)e 173
D-55218 Ingelheim am Rhein

EU/1/98/090/001-012

24.1.2001

22.1.2001

Rebif

Ares Serono (Europe) Ltd
24 Gilbert Street
London W1Y 1RJ
United Kingdom

EU/1/98/063/001-006

24.1.2001

29.1.2001

Novomix 30

29.1.2001

Remicade

29.1.2001

Betaferon

29.1.2001

Gonal F

Novo Nordisk A/S
Novo AllØ
DK-2880 Bagsv(cid:230)rd

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Schering AG
D-13342 Berlin

Ares Serono (Europe) Ltd
24 Gilbert Street
London W1Y 1RJ
United Kingdom

EU/1/00/142/001-008

31.1.2001

EU/1/99/116/001-003

31.1.2001

EU/1/95/003/001-004

30.1.2001

EU/1/95/001/021

30.1.2001

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Official Journal of the European Communities

20.2.2001

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

29.1.2001

Cystagon

2.2.2001

Pritor

Orphan Europe SARL
Immeuble (cid:145)Le Guillaumet(cid:146)
60, avenue du PrØsident-Wilson
F-92046 Paris-La DØfense

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/97/039/001-004

30.1.2001

EU/1/98/089/001-014

6.2.2001

6.2.2001

Lantus

Aventis Pharma Deutschland GmbH
Br(cid:252)ningstra(cid:223)e 50
D-65926 Frankfurt am Main

EU/1/00/134/001-007

7.2.2001

(cid:151) Withdrawal of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93)

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

22.1.2001

Echogen

22.1.2001

Rotashield

Sonus Pharmaceuticals Ltd
Knyvett House
The Causeway
Staines
Middlesex TW18 3BA
United Kingdom

Wyeth-Lederle Vaccines SA
Rue du Bosquet 15
B-1348 Louvain-la-Neuve

EU/1/98/072/001

24.1.2001

EU/1/99/105/001

24.1.2001

29.1.2001

Novonorm

Novo Nordisk A/S
Novo AllØ
DK-2880 Bagsv(cid:230)rd

EU/1/98/076/003, 010, 017 31.1.2001

(cid:151) Suspension of a marketing authorisation (Article 12 of Regulation (EEC) No 2309/93)

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

29.1.2001

Tasmar

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

EU/1/97/044/001-006

31.1.2001

(cid:151) Issuing of a marketing authorisation (Article 34 of Regulation (EEC) No 2309/93): Accepted

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

2.2.2001

Bayovac CSF E2

Bayer AG
Gesch(cid:228)ftsbereich Tiergesundheit
D-51368 Leverkusen

EU/2/00/025/001-004

6.2.2001

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Official Journal of the European Communities

C 53/5

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

29.1.2001

Pirsue

Pharmacia & Upjohn
Rijkweg 12
B-2870 Puurs

EU/2/00/027/001-003

31.1.2001

(cid:151) Modification of a marketing authorisation (Article 34 of Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

2.2.2001

Stronghold

6.2.2001

Econor

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Novartis Animal
Health Austria GmbH
Biochemiestra(cid:223)e 10
A-6250 Kundl

EU/2/99/014/001-011

6.2.2001

EU/2/98/010/023-024

7.2.2001

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)

(cid:151) Modification of a national marketing authorisation

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing authorisation

Member State concerned

Date of
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).