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Document 52006XC0224(01)

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)

OJ C 46, 24.2.2006, p. 21–24 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

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 Parliament 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 immunoglobulin (IVIg)

Baxter AG, Industriestraße 67, A-1220 Vienna

EU/1/05/329/001-005

Solution for infusion

J06BA02

23.1.2006

19.1.2006

Yttriga

Yttrium (90Y) Chloride

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

EU/1/05/322/001

Radiopharmaceutical precursor, solution

pending

23.1.2006

19.1.2006

CUBICIN

Daptomycin

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

EU/1/05/328/001-002

Powder for concentrate for solution for infusion

Pending

23.1.2006

24.1.2006

Naglazyme

Recombinant human N-acetylgalactosamine 4-sulfatase (galsulfase)

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

EU/1/05/324/001

Concentrate for solution for infusion

A16AB

26.1.2006

24.1.2006

Ionsys

Fentanyl

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 powder, pre-dispensed

pending

26.1.2006

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

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

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

EU/1/01/171/001-012

11.1.2006

9.1.2006

Aerius

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

EU/1/00/160/001-034

11.1.2006

9.1.2006

Azomyr

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

EU/1/00/157/001-034

11.1.2006

9.1.2006

Neoclarityn

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

EU/1/00/161/001-034

11.1.2006

13.1.2006

Bondronat

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

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

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

EU/1/02/222/001-002

24.1.2006

20.1.2006

Iscover

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

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

EU/1/00/157/022-034

24.1.2006

20.1.2006

Aerius

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

EU/1/00/160/022-034

24.1.2006

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

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

EU/1/02/216/001-002

27.1.2006

25.1.2006

REYATAZ

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

EU/1/03/267/001-007

27.1.2006

26.1.2006

PEGASYS

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

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

—   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

24.1.2006

25.1.2006

METACAM

Boehringer Ingelheim Vetmedica GmbH, D-55216 Ingelheim am Rhein

EU/2/97/004/007-008

EU/2/97/004/014-015

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


(1)  OJ L 136, 30.4.2004, p. 1.


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