Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 August to 15 September 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-09-28
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

28.9.2001

EN

Official Journal of the European Communities

C 273/3

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 August to 15 September 2001

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

(2001/C 273/03)

(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

24.8.2001

Synagis

30.8.2001

Twinrix Adult

30.8.2001

Twinrix Paediatric

10.9.2001

Visudyne

10.9.2001

Ovitrelle

12.9.2001

Bondronat

12.9.2001

Bonviva

13.9.2001

Bondronat

13.9.2001

Luveris

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

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

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

Novartis Ophtalmics Europe Ltd
Delta House
Southwood Crescent
Southwood
Farnborough
Hants GU14 0NL
United Kingdom

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

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

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

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

EU/1/99/117/001-002

28.8.2001

EU/1/96/020/001-009

21.9.2001

EU/1/97/029/001-008

31.8.2001

EU/1/00/140/001

12.9.2001

EU/1/00/165/001-006

12.9.2001

EU/1/96/012/001-005

14.9.2001

EU/1/96/013/001-004

14.9.2001

EU/1/96/012/006-008

14.9.2001

EU/1/00/155/001-006

14.9.2001

C 273/4

EN

Official Journal of the European Communities

28.9.2001

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

13.9.2001

Hycamtin

17.9.2001

NeoRecormon

SmithKline Beecham plc
New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

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

EU/1/96/027/001-005

14.9.2001

EU/1/97/031/001-044

19.9.2001

17.9.2001

Novonorm

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

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

19.9.2001

18.9.2001

Pylobactell

Torbet Laboratories Limited
The Guard House
Church Lane
The Historic Dockyard
Chatham
Kent ME4 4TE
United Kingdom

EU/1/98/064/001

19.9.2001

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

Withdrawal of notification of a concentration

(Case COMP/M.2380 (cid:151) F(cid:246)reningsSparbanken/SEB)

(2001/C 273/04)

(Text with EEA relevance)

On 11 June 2001 the Commission received notification of a proposed concentration, pursuant to Article 4
of Council Regulation (EEC) No 4064/89, between F(cid:246)reningsSparbanken and SEB. On 19 September 2001,
the notifying parties informed the Commission that they withdrew their notification.