Summary of Community decisions on marketing authorizations in respect of medicinal products from  1.5.2006  to  31.5.2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2006-06-30
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

C 152/8

EN

Official Journal of the European Union

30.6.2006

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1.5.2006 to 31.5.2006

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and
of the Council (1))

(2006/C 152/07)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European

Parliament and of the Council) — Accepted

Date of the
decision

Name of the
medicinal
product

INN (International
Non-Proprietary
Name)

Holder of the marketing
authorization

Number of the entry in
the Community Register

Pharmaceutical
form

5.5.2006

M-M-
RVAXPRO

Measles,
Mumps and
Rubella Vaccine
(Live)

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

EU/1/06/337/001-013

19.5.2006

Zostavax

Zoster vaccine
(Live)

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

EU/1/06/341/001-002

EU/1/06/341/003-013

Powder and
solvent for
suspension for
injection

Powder and
solvent for
suspension for
injection

Powder and
solvent for
suspension for
injection in a
pre-filled
syringe

ATC code
(Anatomical
Therapeutic
Chemical
Code)

Date of
notification

J07BD52

11.5.2006

(Non applic-
able)

23.5.2006

19.5.2006 Ganfort

bimatoprost/
timolol

29.5.2006

Evoltra

clofarabine

Allergan Pharmaceuticals
Ireland
Castlebar Road
Westport
Co. Mayo
Ireland

Bioenvision Limited
Bassett House
5 Southwell Park Road
Camberley
Surrey, GU15 3PU
United Kingdom

EU/1/06/340/001-002

Eye drops, solu-
tion

S01ED 51

23.5.2006

EU/1/06/334/001-004

Concentrate for
solution for
infusion

L01BB0680

31.5.2006

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European

Parliament and of the Council) — Rejected

Date of the
decision

Name of the
medicinal
product

19.5.2006

Zelnorm

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

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

—

24.5.2006

(1) OJ L 136 of 30.4.2004, p. 1.

30.6.2006

EN

Official Journal of the European Union

C 152/9

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the Euro-

pean Parliament and of the Council) — Accepted

Date of the
decision

Name of the
medicinal
product

2.5.2006

Agenerase

2.5.2006

Ventavis

5.5.2006

Vivanza

5.5.2006

AVANDIA

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Glaxo Group Ltd,
Greenford
Middlesex UB6 0NN
United Kingdom

Schering AG
Müllerstraße 170-178
D-13342 Berlin

Bayer AG
D-51368 Leverkusen

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex, TW8 9GS
United Kingdom

EU/1/00/148/001-004

4.5.2006

EU/1/03/255/001-005

4.5.2006

EU/1/03/249/001-012

11.5.2006

EU/1/00/137/001-018

11.5.2006

5.5.2006

Lantus

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/001-029

11.5.2006

5.5.2006

Dynastat

Pfizer Ltd,
Ramsgate Road
Sandwich, Kent CT 13 9NJ
United Kingdom

Pharmacia Europe EEIG
Sandwich
Kent, CT13 9NJ
United Kingdom

EU/1/02/209/001-008

11.5.2006

5.5.2006

Insuman

Aventis Pharma Deutschland GmbH
Brueningstraße 50
D-65926 Frankfurt am Main

EU/1/97/030/065-084

11.5.2006

5.5.2006

Apidra

Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/04/285/013-020

11.5.2006

5.5.2006

Levitra

10.5.2006

GONAL-f

10.5.2006

Forcaltonin

16.5.2006

Lyrica

Bayer AG
D-51368 Leverkusen

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

Unigene UK Limited
191 Sparrows Herne
Bushey Heath
Hertfordshire WD23 1AJ
United Kingdom

PFIZER Ltd
Ramsgate Road
Sandwich
Kent CT 13 9NJ
United Kingdom

EU/1/03/248/001-012

11.5.2006

12.5.2006

EU/1/95/001/001
EU/1/95/001/003-005
EU/1/95/001/009
EU/1/95/001/012
EU/1/95/001/021-022
EU/1/95/001/035

EU/1/98/093/002

16.5.2006

EU/1/04/279/033-035

17.5.2006

19.5.2006

Caelyx

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

EU/1/96/011/001-004

23.5.2006

C 152/10

EN

Official Journal of the European Union

30.6.2006

Date of the
decision

Name of the
medicinal
product

19.5.2006

Osigraft

19.5.2006

Xagrid

19.5.2006

Nespo

19.5.2006

Aranesp

19.5.2006

IntronA

19.5.2006

PegIntron

19.5.2006

Viraferon

19.5.2006

ViraferonPeg

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

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

Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park
Chineham, Basingstoke
Hampshire RG24 8EP
United Kingdom

Dompé Biotec S.p.A.
Via San Martino 12
I-20122 Milano

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Nederland

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

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

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

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

EU/1/01/179/001

24.5.2006

EU/1/04/295/001

23.5.2006

EU/1/01/184/001-056

23.5.2006

EU/1/01/185/001-056

23.5.2006

EU/1/99/127/001-039

23.5.2006

EU/1/00/131/001-050

23.5.2006

EU/1/99/128/001-037

23.5.2006

EU/1/00/132/001-046

23.5.2006

22.5.2006

Prandin

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/00/162/019-021

24.5.2006

22.5.2006

Herceptin

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom

29.5.2006

NovoNorm

29.5.2006

Puregon

29.5.2006

PEGASYS

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Organon N.V
P.O. Box 20
5340 BH Oss
Nederland

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom

EU/1/00/145/001

24.5.2006

EU/1/98/076/022-024

31.5.2006

EU/1/96/008/001-041

31.5.2006

EU/1/02/221/001-010

31.5.2006

30.6.2006

EN

Official Journal of the European Union

C 152/11

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Date of the
decision

Name of the
medicinal
product

29.5.2006

Emend

29.5.2006

Emend

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

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

31.5.2006

Xeristar

31.5.2006

Viramune

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

31.5.2006

Aldurazyme

31.5.2006

Kineret

31.5.2006

Prialt

31.5.2006

Trudexa

Genzyme Europe B.V
Gooimeer 10
1411 DD Naarden
Nederland

Amgen Europe B.V
Minervum 7061
4817 ZK Breda
Nederland

Elan Pharma International Ltd
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/03/262/001-008

31.5.2006

EU/1/03/262/007-008

31.5.2006

EU/1/04/297/001-008

2.6.2006

EU/1/97/055/001-003

2.6.2006

EU/1/03/253/001-003

2.6.2006

EU/1/02/203/001-004

2.6.2006

EU/1/04/302/001-004

2.6.2006

EU/1/03/257/001-006

2.6.2006

31.5.2006

Ariclaim

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

EU/1/04/283/001-007

2.6.2006

31.5.2006

Xenical

31.5.2006

AVANDIA

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
United Kingdom

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex, TW8 9GS
United Kingdom

EU/1/98/071/001-006

2.6.2006

EU/1/00/137/002-018

2.6.2006

C 152/12

EN

Official Journal of the European Union

30.6.2006

Date of the
decision

Name of the
medicinal
product

31.5.2006

Rebif

31.5.2006

YENTREVE

31.5.2006

Enbrel

31.5.2006

Abilify

31.5.2006

Vfend

31.5.2006

Rapamune

31.5.2006

Xeloda

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Serono Europe Ltd.
56, Marsh Wall
London E14 9TP
United Kingdom

Eli Lilly Nederland B.V
Grootslag 1-5
3991 RA Houten
Nederland

Abbott Laboratories Ltd.
Queenborough
Kent ME11 5EL
United Kingdom

Otsuka Pharmaceutical Europe Ltd
Commonwealth House
2 Chalkhill Road
Hammersmith
London W6 8DW
United Kingdom

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

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

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

EU/1/98/063/001-007

2.6.2006

EU/1/04/280/001-007

2.6.2006

EU/1/06/350/001-011

2.6.2006

EU/1/04/276/001-035

2.6.2006

EU/1/02/212/001-026

2.6.2006

EU/1/01/171/007-010

2.6.2006

EU/1/00/163/001-002

2.6.2006

31.5.2006

Aprovel -77

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

EU/1/97/046/001-033

2.6.2006

31.5.2006

Cymbalta

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

EU/1/04/296/001-008

2.6.2006

— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the Euro-

pean Parliament and of the Council)

Date of the
decision

Name of the
medicinal
product

5.5.2006

Infergen

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Astellas Pharma Europe B.V
Elisabethhof 19
2353 EW Leiderdorp
Nederland

EU/1/98/087/001-003

11.5.2006

30.6.2006

EN

Official Journal of the European Union

C 152/13

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the Euro-

pean Parliament and of the Council) — Accepted

Date of the
decision

22.5.2006

Name of the
medicinal
product

Aivlosin
W 04-W 05

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

ECO Animal Health Ltd
78 Coombe Road
New Malden
Surrey KT3 4QS
United Kingdom

EU/2/04/044/001-005

24.5.2006

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