Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 May 2001 to 15 June 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-06-29
Institutions: European Commission
Subjects: directory, market approval, marketing, medicinal product, pharmaceutical legislation

29.6.2001

EN

Official Journal of the European Communities

C 183/7

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 May 2001 to 15 June 2001

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

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

accepted

(2001/C 183/04)

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

17.5.2001

Osteogenic protein 1
Howmedica Inter-
national S. de R.L.

28.5.2001

Uprima

Howmedica International S. de R.L.
Division of Stryker Corporation
Raheen Industrial Estate
Raheen
Limerick
Ireland

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/01/179/001

18.5.2001

EU/1/01/180/001-010

30.5.2001

28.5.2001

Apomorphine
Hydrochloride
Abbott
Laboratories Ltd

Abbott SpA
I-04010 Campoverde di Aprilia
(Latina)

EU/1/01/182/001-010

30.5.2001

28.5.2001

Ixense

8.6.2001

Aranesp

8.6.2001

Nespo

Takeda Europe R & D Centre Ltd
Savanah House
11/12 Charles II Street
London SW1Y 4QU
United Kingdom

EU/1/01/181/001-007

30.5.2001

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

EU/1/01/185/001-030

11.6.2001

EU/1/01/184/001-030

11.6.2001

(cid:151) Modification of a marketing authorisation (Article 12 of Council 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

17.5.2001

Tritanrix HepB

17.5.2001

Twinrix Adult

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

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

EU/1/96/014/001-002

18.5.2001

EU/1/96/020/001-009

18.5.2001

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

C 183/8

EN

Official Journal of the European Communities

29.6.2001

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

17.5.2001

Luveris

17.5.2001

Enbrel

18.5.2001

Zeffix

18.5.2001

NeoSpect

18.5.2001

Fareston

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

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

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

Nycomed Imaging AS
Nycoveien 1-2
PO Box 4220 Torshov
N-0401 Oslo

Orion Corporation
Orionintie 1
FIN-02200 Espoo

EU/1/00/155/001-006

21.5.2001

EU/1/99/126/001

21.5.2001

EU/1/99/114/001-003

22.5.2001

EU/1/00/154/001-002

22.5.2001

EU/1/96/004/001-002

22.5.2001

18.5.2001

Infanrix HepB

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

EU/1/97/048/001-012

22.5.2001

18.5.2001

Humalog

1.6.2001

Synagis

Eli Lilly Nederland BV
Krijtwal 17-23
3432 ZT Nieuwegein
Nederland

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/96/007/001-018

22.5.2001

EU/1/99/117/001-002

5.6.2001

6.6.2001

Ammonaps

Orphan Europe
Immeuble «Le Guillaumet»
F-92046 Paris-La-DØfense

EU/1/99/120/001-004

8.9.2001

8.6.2001

Avonex

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

EU/1/97/033/001-002

13.6.2001

8.6.2001

Viracept

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

EU/1/97/054/001-003

13.6.2001

29.6.2001

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Official Journal of the European Communities

C 183/9

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

8.6.2001

Zerit

8.6.2001

Olansek

8.6.2001

Crixivan

14.6.2001

Sustiva

14.6.2001

Stocrin

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

EU/1/96/009/001-009

13.6.2001

Eli Lilly UK Ltd
Kingsclere Road
Basingstoke
Hampshire
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

DuPont Pharmaceuticals Ltd
Wedgwood Way
Stevenage
Herts SG1 4QN
United Kingdom

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

EU/1/96/021/001-010

13.6.2001

EU/1/96/024/001-010

13.6.2001

EU/1/99/110/001-004

19.6.2001

EU/1/99/111/001-004

19.6.2001

14.6.2001

Zyprexa
Olanzapine

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

EU/1/96/022/001-015

15.6.2001

14.6.2001

Insuman

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/97/030/028-084

18.6.2001

14.6.2001

Norvir

14.6.2001

Zyprexa
Velotab

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

EU/1/96/016/001-003

15.6.2001

EU/1/99/125/001-004

15.6.2001

C 183/10

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Official Journal of the European Communities

29.6.2001

(cid:151) Modification of a marketing authorisation (Article 34 of Council 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

17.5.2001

Oxyglobin

14.6.2001

Pirsue

Biopure Netherlands BV
Prinses Irenestraat 59
1077 WV Amsterdam
Nederland

Pharmacia & Upjohn
Rijkweg 12
B-2870 Puurs

EU/2/99/015/001

21.5.2001

EU/2/00/027/001-003

15.6.2001

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

Prior notification of a concentration

(Case COMP/M.2512 (cid:151) EQT Northern Europe/Electrolux)

Candidate case for simplified procedure

(2001/C 183/05)

(Text with EEA relevance)

1.
On 21 June 2001 the Commission received notification of a proposed concentration pursuant to
Article 4 of Council Regulation (EEC) No 4064/89 (1), as last amended by Regulation (EC) No 1310/97 (2),
by which the undertaking Erusiel AB, controlled by EQT Northern Europe Ltd (EQT), acquires, within the
meaning of Article 3(1)(b) of the Regulation, control of the whole of AB Electrolux’s (Electrolux) leisure
appliances operations (the Business) by way of purchase of assets.

2.

The business activities of the undertakings concerned are:

(cid:151) Erusiel AB: vehicle to acquire Electrolux’s leisure appliances operations,

(cid:151) EQT: private equity fund management,

(cid:151) Electrolux: consumer durables and professional products for indoor and outdoor use,

(cid:151) the Business: leisure appliances.

On preliminary examination, the Commission finds that the notified concentration could fall within
3.
the scope of Regulation (EEC) No 4064/89. However, the final decision on this point is reserved. Pursuant
to the Commission Notice on a simplified procedure for treatment of certain concentrations under
Regulation (EEC) No 4064/89 (3), it should be noted that this case is a candidate for treatment under
the procedure set out in the notice.

(1) OJ L 395, 30.12.1989, p. 1; corrigendum: OJ L 257, 21.9.1990, p. 13.
(2) OJ L 180, 9.7.1997, p. 1; corrigendum: OJ L 40, 13.2.1998, p. 17.
(3) OJ C 217, 29.7.2000, p. 32.