Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 January 2006  to  31 January 2006  (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2006-02-24
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

24.2.2006

EN

Official Journal of the European Union

C 46/21

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 January 2006 to 31 January 2006

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

(2006/C 46/03)

— 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

ATC code
(Anatomical
Therapeutic
Chemical
Code)

Date of
notification

19.1.2006 Kiovig

Human normal
immunoglo-
bulin (IVIg)

Baxter AG, Industriestraße 67,
A-1220 Vienna

EU/1/05/329/001-005 Solution for

J06BA02

23.1.2006

19.1.2006 Yttriga

Yttrium (90Y)
Chloride

AEA Technology QSA GmbH,
Gieselweg
D-38110
1,
Braunschweig

EU/1/05/322/001

infusion

Radiopharma-
ceutical
precursor, solu-
tion

pending

23.1.2006

19.1.2006 CUBICIN

Daptomycin

24.1.2006 Nagla-
zyme

Recombinant
human N-acet-
ylgalactosamine
4-sulfatase
(galsulfase)

24.1.2006

Ionsys

Fentanyl

Chiron Corporation Limited,
Symphony House, 7 Cowley
Business Park, High Street,
Cowley,
UB8
UXBRIDGE,
2AD, United Kingdom

EU/1/05/328/001-002 Powder for

Pending

23.1.2006

concentrate for
solution for
infusion

BioMarin Europe Limited, 29,
Earlsfort Terrace, Dublin 2,
Ireland

EU/1/05/324/001

Concentrate for
solution for
infusion

A16AB

26.1.2006

Janssen-Cilag International NV,
Turnhoutseweg 30, B-2340
Beerse

EU/1/05/326/001

Iontophoretic
transdermal
system

N02A B03

26.1.2006

24.1.2006

Exubera

Insulin human

Aventis/Pfizer EEIG, Ramsgate
Road, Sandwich, Kent CT13
9NJ, United Kingdom

EU/1/05/327/001-017 Inhalation

pending

26.1.2006

powder, pre-
dispensed

31.1.2006 Macugen

pegaptanib
sodium

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

EU/1/05/325/001

Solution for
injection

S01XA17

2.2.2006

— Modification 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

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of notification

9.1.2006

Arava

Aventis Pharma Deutschland GmbH, D-65926
Frankfurt am Main

EU/1/99/118/001-010

11.1.2006

9.1.2006

Karvea

Bristol-Myers Squibb Pharma EEIG, Uxbridge
Business Park, Sanderson Road, Uxbridge UD8
1DH, United Kingdom

EU/1/97/049/001-033

11.1.2006

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

C 46/22

EN

Official Journal of the European Union

24.2.2006

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

9.1.2006

Aprovel

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

EU/1/97/046/001-033

11.1.2006

9.1.2006

Rapamune

9.1.2006

Aerius

9.1.2006

Azomyr

9.1.2006

Neoclarityn

13.1.2006

Bondronat

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

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

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

EU/1/01/171/001-012

11.1.2006

EU/1/00/160/001-034

11.1.2006

EU/1/00/157/001-034

11.1.2006

EU/1/00/161/001-034

11.1.2006

EU/1/96/012/009-010

17.1.2006

13.1.2006

Humalog

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

EU/1/96/007/001-008
EU/1/96/007/010-030

17.1.2006

13.1.2006

PritorPlus

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

EU/1/02/215/001-010

17.1.2006

13.1.2006

Hycamtin

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

EU/1/96/027/001
EU/1/96/027/003-005

17.1.2006

13.1.2006

Zonegran

Eisai Limited, 3, Shortlands, London W6 8EE,
United Kingdom

EU/1/04/307/001-010

17.1.2006

19.1.2006

Aldurazyme

Genzyme Europe B.V., Gooimeer 10, Naarden
1411 DD, Nederland

EU/1/03/253/001-003

23.1.2006

19.1.2006

Rebif

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

EU/1/98/063/007

24.1.2006

19.1.2006

Velcade

Janssen-Cilag International NV, Turnhoutseweg
30, B-2340 Beerse

EU/1/04/274/001

23.1.2006

19.1.2006

Ceprotin

Baxter AG, Industriestraße 67, A-1220 Vienna

EU/1/01/190/001-002

23.1.2006

20.1.2006

Humira

Abbott Laboratories Ltd, Queenborough, Kent
ME11 5EL, United Kingdom

EU/1/03/256/001-006

24.1.2006

20.1.2006

Tamiflu

20.1.2006

Iscover

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

EU/1/02/222/001-002

24.1.2006

Bristol-Myers Squibb Pharma EEIG, Uxbridge
Business Park, Sanderson Road, Uxbridge UD8
1DH, United Kingdom

EU/1/98/070/001a-b,
002a-b, 003a-b, 004a-b

24.1.2006

20.1.2006

Plavix

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

EU/1/98/069/001a-b,
002a-b, 003a-b, 004a-b

24.1.2006

20.1.2006

Azomyr

20.1.2006

Aerius

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

EU/1/00/157/022-034

24.1.2006

EU/1/00/160/022-034

24.1.2006

24.2.2006

EN

Official Journal of the European Union

C 46/23

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

20.1.2006

Neoclarityn

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

EU/1/00/161/022-034

24.1.2006

24.1.2006

Luveris

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

EU/1/00/155/001-006

26.1.2006

24.1.2006

Taxotere

Aventis Pharma S.A., 20, avenue Raymond Aron,
F-92165 Antony Cedex

EU/1/95/002/001-002

26.1.2006

24.1.2006

Infanrix Penta

GlaxoSmithKline Biologicals S.A., rue de l'Institut
89, B-1330 Rixensart

EU/1/00/153/001-010

26.1.2006

24.1.2006

Infanrix Hexa

GlaxoSmithKline Biologicals S.A., rue de l'Institut
89, B-1330 Rixensart

EU/1/00/152/001-018

26.1.2006

25.1.2006

AZILECT

Teva Pharma GmbH, Kandelstraße 10, D-79199
Kirchzarten

EU/1/04/304/001-007

30.1.2006

25.1.2006

Tamiflu

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

EU/1/02/222/001-002

27.1.2006

25.1.2006

Dynastat

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

EU/1/02/209/001-008

30.1.2006

25.1.2006

Invanz

25.1.2006

REYATAZ

26.1.2006

PEGASYS

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

Bristol-Myers Squibb Pharma EEIG, 141-149
Staines Road, Hounslow TW3 3JA, United
Kingdom

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

EU/1/02/216/001-002

27.1.2006

EU/1/03/267/001-007

27.1.2006

EU/1/02/221/001-010

30.1.2006

30.1.2006

Avandamet

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

EU/1/03/258/001-022

1.2.2006

30.1.2006

Alimta

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

EU/1/04/290/001

1.2.2006

30.1.2006

Ferriprox

Apotex Europe Ltd, Rowan House, 41 London
Street, Reading, Berkshire, RG1 4PS, United
Kingdom

EU/1/99/108/001

6.2.2006

30.1.2006

Trudexa

Abbott Laboratories Ltd, Queenborough, Kent
ME11 5EL, United Kingdom

EU/1/03/257/001-006

1.2.2006

31.1.2006

NeoSpect

Amersham Health AS, Nycoveien 1-2, P.O. Box
4220 Nydalen, N-0401 Oslo

EU/1/00/154/001-002

2.2.2006

31.1.2006

Betaferon

Schering AG Pharma, D-13342 Berlin

EU/1/95/003/003-004

2.2.2006

31.1.2006

Simulect

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

EU/1/98/084/001-002

2.2.2006

31.1.2006

Ovitrelle

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

EU/1/00/165/001-007

7.2.2006

31.1.2006

Vfend

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

EU/1/02/212/001-026

2.2.2006

C 46/24

EN

Official Journal of the European Union

24.2.2006

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and

of the Council): 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

19.1.2006

Zubrin

Schering-Plough Limited, Schering-Plough House,
Shire Park, Welwyn Garden City, Hertfordshire,
AL7 1TW, United Kingdom

EU/2/00/028/002-008

23.1.2006

20.1.2006

Nobivac Bb

Intervet International B.V., Wim de Körverstraat
35, PO Box 31, 5830 AA Boxmeer, Nederland

EU/1/00/161/001

24.1.2006

20.1.2006

Purevax FeLV

Merial, 29, Avenue Tony Garnier, F-69007 Lyon

EU/2/00/019/001-003
EU/2/00/019/005-007

25.1.2006

METACAM

Boehringer
D-55216 Ingelheim am Rhein

Ingelheim Vetmedica

GmbH,

EU/2/97/004/007-008
EU/2/97/004/014-015

24.1.2006

27.1.2006

25.1.2006

Clomicalm

Novartis Tiergesundheit GmbH, Zielstattstrasse
40, D-81379 München

EU/2/98/007/001-003

27.1.2006

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