Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 July 2001 to 15 August 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-08-31
Institutions: European Commission
Subjects: market approval, medicinal product

C 243/2

EN

Official Journal of the European Communities

31.8.2001

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

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

(2001/C 243/02)

(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

1.8.2001

Inomax

AGA AB
S-181 81 Liding(cid:246)

EU/1/01/194/001

6.8.2001

1.8.2001

Liprolog

3.8.2001

Fabrazyme

3.8.2001

Replagal

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

Genzyme BV
Gooimeer 10
1411 DD Naarden
The Netherlands

TKT Europe-5S AB
Rinkebyv(cid:228)gen 11B
S-182 36 Danderyd

EU/1/01/195/001-007

3.8.2001

EU/1/01/188/001-003

7.8.2001

EU/1/01/189/001

7.8.2001

(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

19.7.2001

Tractocile

Ferring AB
Soldattorpsv(cid:228)gen 5 (cid:150) Box 30 047
S-200 61 Limhamn

EU/1/99/124/001-002

20.7.2001

19.7.2001

Rebif

19.7.2001

Viracept

20.7.2001

Gonal-F

26.7.2001

Optruma

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

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

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

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

Eli Lilly Nederland BV
Krijtwal 17-23
3432 ZT Nieuwegen
The Netherlands

EU/1/98/063/001-006

20.7.2001

EU/1/97/054/001-005

20.7.2001

EU/1/95/001/021

23.7.2001

EU/1/98/074/001-004

27.7.2001

31.8.2001

EN

Official Journal of the European Communities

C 243/3

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

26.7.2001

Puregon

NV Organon
Kloosterstraat 6
Postbus 20
5340 BH Oss
The Netherlands

EU/1/96/008/001-039

27.7.2001

26.7.2001

Novorapid

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

EU/1/99/119/001-008

27.7.2001

31.7.2001

Remicade

31.7.2001

Remicade

Centocor BV
Einsteinweg 101
2333 CB Leiden
The Netherlands

Centocor BV
Einsteinweg 101
2333 CB Leiden
The Netherlands

EU/1/99/116/001-003

2.8.2001

EU/1/99/116/001-003

2.8.2001

31.7.2001

Arava

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-009

6.8.2001

31.7.2001

Combivir

1.8.2001

Optison

1.8.2001

Exelon

1.8.2001

Viracept

3.8.2001

Rapamune

6.8.2001

Aerius

6.8.2001

Allex

Glaxo Group Ltd
Greenford Road
Greenford
UB6 0NN
United Kingdom

Mallinckrodt Medical GmbH
Josef-Dietzgen-Stra(cid:223)e 1(cid:151)3
D-53773 Hennef

Novartis Europharm Limited
Wimblehurst Road
Horsham
RH12 5AB
United Kingdom

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

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

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

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

EU/1/98/058/001-002

2.8.2001

EU/1/98/065/001-002

3.8.2001

EU/1/98/066/001-013

3.8.2001

EU/1/97/054/001-004

3.8.2001

EU/1/01/171/001-005

7.8.2001

EU/1/00/160/001-013

8.8.2001

EU/1/00/159/001-013

8.8.2001

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EN

Official Journal of the European Communities

31.8.2001

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

6.8.2001

Azomyr

6.8.2001

Neoclarityn

6.8.2001

Opulis

6.8.2001

Xenical

6.8.2001

Prevenar

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

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

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

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

Wyeth Lederle Vaccines SA
Rue du bosquet 15
B-1348 Louvain-La-Neuve

EU/1/00/157/001-013

8.8.2001

EU/1/00/161/001-013

8.8.2001

EU/1/00/158/001-013

8.8.2001

EU/1/98/071/001-006

8.8.2001

EU/1/00/167/001-004

8.8.2001

6.8.2001

Apomorphine hydro-
chloride Abbott Ltd

Abbott SpA
I-0410 Campoverde di Aprilia

EU/1/01/182/001-010

8.8.2001

6.8.2001

Enbrel

6.8.2001

Prandin

9.8.2001

Renagel

13.8.2001

Prometax

13.8.2001

Viramune

13.8.2001

Procomvax

13.8.2001

Taxotere

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

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

Genzyme BV
Gooimeer 10
1411 DD Naarden
The Netherlands

Novartis Europharm Limited
Wimblehurst Road
Horsham
RH12 4AB
United Kingdom

Boehringer Ingelheim International
GmbH
Binger Stra(cid:223)e 173
D-55216 Ingelheim am Rhein

Aventis Pasteur MSD SNC
8, rue Jonas Salk
F-69007 Lyon

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

EU/1/99/126/001

8.8.2001

EU/1/00/162/001-018

8.8.2001

EU/1/99/123/001-010

10.8.2001

EU/1/98/092/001-013

14.8.2001

EU/1/97/055/001-002

14.8.2001

EU/1/99/104/001

14.8.2001

EU/1/95/002/001-002

14.8.2001

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Official Journal of the European Communities

C 243/5

(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

19.7.2001

Orlaam

Sipaco Internacional Lda
Avenida 5 de Outubro, 267-6o dto
P-1600 Lisbon

EU/1/97/041/001-002

23.7.2001

(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

19.7.2001

Zubrin

6.8.2001

Doxirobe gel

S-P Veterinary
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Pharmacia NV/SA
Rijksweg 12
B-2870 Puurs

EU/2/00/028/001-008

20.7.2001

EU/2/99/012/001-002

8.8.2001

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

Investigation of an alliance agreement in the field of air transport

(2001/C 243/03)

1.
On 6 August 2001 British Airways (BA) and American Airlines (AA) informed the Commission of
their intention to deepen their bilateral alliance on transatlantic routes. The proposed alliance would
include profit-sharing, code-sharing, joint marketing and schedule coordination.

2.
BA and AA are seeking clearance for this alliance under EU competition law from the European
Commission and the UK Office of Fair Trading (OFT). The OFT will consider the parties’ application for an
exemption under Article 81(3) (OFT Enforcement Regulations Public Register, www.oft.gov.uk/html/about/
enfregpr.htm). The Commission will also conduct an investigation and may open a formal procedure under
Article 85 of the Treaty.

3.
The Commission invites interested third parties to submit any observations they may have on this
alliance. Observations must reach the Commission not later than 20 working days following the date
this publication. They can be sent by fax No (32-2) 295 01 28) or by post, quoting reference
of
COMP/38.147, to:

European Commission,
Directorate-General for Competition,
Greffe Anti-Trust,
Rue Joseph II/Jozef II-straat 70,
B-1000 Brussels.