Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 January to 15 February 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-02-22
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 49/2

EN

Official Journal of the European Communities

22.2.2002

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 January to 15 February 2002

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

(2002/C 49/02)

(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

5.2.2002

Viread

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

7.2.2002

(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

23.1.2002

Benefix

28.1.2002

Lantus

28.1.2002

Plavix

28.1.2002

NovoNorm

28.1.2002

Prandin

28.1.2002

Sonata

28.1.2002

Prevenar

28.1.2002

Luveris

28.1.2002

Gonal F

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

Genetics Institute of Europe BV
Fraunhoferstra(cid:223)e 15
D-82152 Planegg/Martinsried

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

EU/1/97/047/001-003

23.1.2002

EU/1/00/134/001-011

5.2.2002

Sanofi Pharma Bristol-Myers
Squibb SNC
174, avenue de France
F-75013 Paris

EU/1/98/069/001a,
001b, 002a, 002b, 003a,
003b

30.1.2002

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

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

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

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

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

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

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

31.1.2002

EU/1/00/162/001-018

31.1.2002

EU/1/99/102/001-008

30.1.2002

EU/1/00/167/001-005

31.1.2002

EU/1/00/155/001-006

30.1.2002

EU/1/95/001/021

30.1.2002

22.2.2002

EN

Official Journal of the European Communities

C 49/3

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

28.1.2002

Infergen

28.1.2002

Beromun

28.1.2002

Cystagon

28.1.2002

Zerene

29.1.2002

Tritanrix HepB

Yamanouchi Europe BV
Elisabethhof 19
2353 EW Leiderdorp
Nederland

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

EU/1/98/087/001-003

31.1.2002

EU/1/99/097/001

31.1.2002

Orphan Europe
Immeuble (cid:145)Le Guillaumet(cid:146)
F-92046 Paris-La DØfense

Wyeth Research Limited
Huntercombe Lane South
Taplow
Maidenhead
Berkshire SL6 0PH
United Kingdom

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

EU/1/97/039/001-004

31.1.2002

EU/1/99/099/001-006

28.1.2002

EU/1/96/014/001-003

31.1.2002

29.1.2002

Iscover

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

EU/1/98/070/001a, 001b,
002a, 002b, 003a, 003b

7.2.2002

29.1.2002

Prevenar

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

EU/1/00/167/001-005

4.2.2002

30.1.2002

Zerit

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

EU/1/96/009/001-009

7.2.2002

4.2.2002

Hycamtin

4.2.2002

Viracept

5.2.2002

Ferriprox

SmithKline Beecham plc
Great West Road
Brentford
Middlesex TW8 9BD
United Kingdom

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

Apotex Europe Ltd
22 Clarendon Road
Leeds LS2 9NZ
United Kingdom

EU/1/96/027/001, 003,
004, 005

6.2.2002

EU/1/97/054/004-005

6.2.2002

EU/1/99/108/001

7.2.2002

C 49/4

EN

Official Journal of the European Communities

22.2.2002

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

5.2.2002

Benefix

5.2.2002

CellCept

5.2.2002

Puregon

5.2.2002

Viracept

6.2.2002

CellCept

6.2.2002

ViraferonPeg

6.2.2002

PegIntron

6.2.2002

Renagel

6.2.2002

Twinrix Paediatric

6.2.2002

Infanrix HepB

6.2.2002

Infanrix Hexa

6.2.2002

Infanrix Penta

Genetic Institute of Europe BV
Lochhamer Stra(cid:223)e 11
D-82152 Martinsried

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

Organon NV
PO Box 20
5340 BH Oss
Nederland

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

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

Schering Plough Europe
Rue de Stalle/Stallestraat 73
B-1180 Brussels

Schering Plough Europe
Rue de Stalle/Stallestraat 73
B-1180 Brussels

Genzyme BV
Gooimeer 10
1411 DD Naarden
Nederland

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

GlaxoSmithKline
Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart

EU/1/97/047/001-003

7.2.2002

EU/1/96/005/002, 004

8.2.2002

EU/1/96/008/001-039

7.2.2002

EU/1/97/054/001-005

8.2.2002

EU/1/96/005/001-004

8.2.2002

EU/1/00/132/031-050

8.2.2002

EU/1/00/131/031-050

8.2.2002

EU/1/99/123/001-010

8.2.2002

EU/1/97/029/009-010

8.2.2002

EU/1/97/048/013-014

8.2.2002

EU/1/00/152/017-018

8.2.2002

EU/1/00/153/009-010

8.2.2002

22.2.2002

EN

Official Journal of the European Communities

C 49/5

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

6.2.2002

Refludan

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

EU/1/97/035/001-004

11.2.2002

6.2.2002

Enbrel

7.2.2002

Rebetol

7.2.2002

Comtan

7.2.2002

Comtess

8.2.2002

Remicade

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

Schering Plough Europe
Rue de Stalle/Stallestraat 73
B-1180 Brussels

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

Orion Corporation
Orionintie 1
FIN-02200 Espoo

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

EU/1/99/126/001

8.2.2002

EU/1/99/107/001-003

14.2.2002

EU/1/98/081/001-004

14.2.2002

EU/1/98/082/001-004

14.2.2002

EU/1/99/116/001-003

14.2.2002

(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

28.1.2002

Triacelluvax

Chiron SpA
Via Fiorentina 1
I-53100 Siena

EU/1/98/088/001-009

31.1.2002

(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

28.1.2002

Stronghold

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/2/99/014/001-011

31.1.2002

6.2.2002

Dicural

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

EU/2/97/003/004-015

8.2.2002

C 49/6

EN

Official Journal of the European Communities

22.2.2002

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

6.2.2002

Ibaflin

Intervet International BV
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Nederland

EU/2/00/022/001a,
001b, 002a, 002b, 003a,
003b, 004a, 004b, 005,
006, 007, 008

8.2.2002

6.2.2002

Metacam

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/007-008

8.2.2002

(cid:151) Suspension of a marketing authorisation (Article 40 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

29.1.2002

Econor

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

EU/2/98/010/001-024

31.1.2002

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 2002

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2002/C 49/03)

(cid:151) Issuing, maintenance or modification of a national marketing authorisation

Date of the
becision

Name(s) of the
medicinal product

Holder(s)
of the marketing
authorisation

Member State
concerned

Date of
notification

4.2.2002

Avinew

See Annex

See Annex

5.2.2002

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.