Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 May 2005 to 15 June 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-06-24
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

24.6.2005

EN

Official Journal of the European Union

C 153/3

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 May 2005 to 15 June 2005

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

(2005/C 153/03)

— Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93)

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

18.5.2005

Bonviva

23.5.2005

IntronA

23.5.2005

Viraferon

23.5.2005

Kentera

23.5.2005

DepoCyte

25.5.2005

Invirase

25.5.2005

PegIntron

25.5.2005

ViraferonPeg

2.6.2005

Azopt

2.6.2005

Onsenal

2.6.2005

Glivec

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

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

Schering Plough Europe, Rue de
Stalle, 73, B-1180 Bruxelles —
Stallestraat, 73 — B-1180 Brussel

Schering Plough Europe, Rue de
Stalle, 73, B-1180 Bruxelles —
Stallestraat, 73 — B-1180 Brussel

Nicobrand Limited, 189 Casteroe
Road, Coleraine, Northern Ireland
BT51 3 RP

SkyePharma PLC, 105 Piccadilly,
London W1V
United
Kingdom

9FN,

Roche Registration Ltd., 40, Broad-
water Road, Welwyn Garden City,
Hertfordshire, AL7 3AY, United
Kingdom

Schering Plough Europe, Rue de
Stalle, 73, B-1180 Bruxelles —
Stallestraat, 73 — B-1180 Brussel

Schering Plough Europe, Rue de
Stalle, 73, B-1180 Bruxelles —
Stallestraat, 73 — B-1180 Brussel

(UK)

Laboratories

Alcon
Ltd.,
Pentagon Park, Boundary Way,
Hemel Hempstead, Herts HP2
7UK, United Kingdom

EU/1/03/265/001-002

24.5.2005

EU/1/99/127/001-044

25.5.2005

EU/1/99/128/001-037

25.5.2005

EU/1/03/270/001-003

25.5.2005

EU/1/01/187/001

25.5.2005

EU/1/96/026/002

27.5.2005

EU/1/00/131/001-050

27.5.2005

EU/1/00/132/001-050

27.5.2005

EU/1/00/129/001-003

6.6.2005

Pharmacia-Pfizer EEIG, Ramsgate
Road, Sanwich, CT13 9NJ, United
Kingdom

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

Road,

EU/1/03/259/001-006

6.6.2005

EU/1/01/198/001-013

6.6.2005

C 153/4

EN

Official Journal of the European Union

24.6.2005

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

3.6.2005

Zavesca

3.6.2005

Ariclaim

3.6.2005

Rebetol

Ltd, BSI
Actelion Registration
Building 13th Floor, 389 Chiswick
High Road, London W4 4AL,
United Kingdom

Boehringer Ingelheim International
GmbH,
173,
Binger
D-5216 Ingelheim am Rhein

Straße

Schering Plough Europe, Rue de
Stalle, 73, B-1180 Bruxelles —
Stallestraat, 73 — B-1180 Brussel

EU/1/02/238/001

7.6.2005

EU/1/04/283/001-006

7.6.2005

EU/1/99/107/001-004

7.6.2005

3.6.2005

Ketek

Aventis Pharma SA, 20 Avenue
Raymond Aron, F-92160 Antony

EU/1/01/191/001-005

7.6.2005

3.6.2005

Levviax

Aventis Pharma SA, 20 Avenue
Raymond Aron, F-92160 Antony

EU/1/01/192/001-005

7.6.2005

3.6.2005

Temodal

Schering Plough Europe, Rue de
Stalle, 73, B-1180 Bruxelles —
Stallestraat, 73 — B-1180 Brussel

EU/1/98/096/001-008

7.6.2005

3.6.2005

Valdyn

Pfizer Limited, Sandwich, Kent,
CT13 9NJ, United Kingdom

EU/1/02/244/001-024

7.6.2005

10.6.2005

Taxotere

10.6.2005

Viracept

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

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

EU/1/95/002/001-002

14.6.2005

EU/1/97/054/001
EU/1/97/054/003-006

14.6.2005

10.6.2005

Azilect

Teva Pharma GmbH, Kandelstraße
10, D-79199 Kirchzarten

EU/1/04/304/001-007

14.6.2005

10.6.2005

Angiox

The Medicines Company UK Ltd,
Suite B, Park House, 11 Milton
Oxfordshire
Abingdon,
Park,
OX14 4RS, United Kingdom

EU/1/04/289/001-002

14.6.2005

10.6.2005

Rayzon

Pharmacia Europe EEIG, Sandwich,
Kent, CT13 9NJ, United Kingdom

EU/1/02/210/001-008

14.6.2005

10.6.2005

Dynastat

Pharmacia Europe EEIG, Sandwich,
Kent, CT13 9NJ, United Kingdom

EU/1/02/209/001-008

14.6.2005

10.6.2005

TachoSil

Nycomed Austria GmbH, St.-Peter-
Straße 25, A-4020 Linz

EU/1/04/277/001-004

14.6.2005

10.6.2005

Bextra

Pharmacia-Pfizer EEIG, Sandwich,
Kent, CT13 9NJ, United Kingdom

EU/1/02/239/001-030

14.6.2005

10.6.2005

NovoMix 30

Novo Nordisk A/S, Novo Allé,
DK-880 Bagsværd

EU/1/00/142/004-005
EU/1/00/142/009-010

14.6.2005

10.6.2005

Protopy

Fujisawa GmbH, Neumarkter Str.
61, D-81673 München

EU/1/02/202/001-006

14.6.2005

24.6.2005

EN

Official Journal of the European Union

C 153/5

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

10.6.2005

Protopic

10.6.2005

Xenical

10.6.2005

Avandia

Fujisawa GmbH, Neumarkter Str.
61, D-81673 München

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

EU/1/02/201/001-006

14.6.2005

EU/1/98/071/001-006

14.6.2005

SmithKline Beecham plc, 980
Brentford,
Great West
9GS United
Middlesex,
Kingdom

Road,

TW8

EU/1/00/137/001-012

14.6.2005

— Issuing of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93)

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

19.5.2005

Naxcel

Pfizer Limited, Sandwich, Kent,
CT13 9NJ, United Kingdom

EU/2/05/053/001

24.5.2005

— Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93)

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

26.5.2005

Econor

Novartis Animal Health Austria
GmbH,
10,
A-250 Kundl

Biochemiestraße

EU/2/98/010/004-006
EU/2/98/010/017-018
EU/2/98/010/021-024

30.5.2005

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 Medicines Agency
7, Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom