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Document 52006XC0224(01)

Ravimite müügilubasid käsitlevate ühenduse otsuste kokkuvõte alates 1.1.2006 kuni 31.1.2006 (Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38)

ELT 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)

Date of document:
24/02/2006; avaldamise kuupäev
Author:
Euroopa Komisjon
Form:
Teatis
Treaty:
Euroopa Ühenduse asutamisleping
Legal basis:
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Select all documents mentioning this document
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24.2.2006   

ET

Euroopa Liidu Teataja

C 46/21

Ravimite müügilubasid käsitlevate ühenduse otsuste kokkuvõte alates 1.1.2006 kuni 31.1.2006

(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 (1) artiklile 13 või 38)

(2006/C 46/03)

—   Müügiloa väljaandmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Heaks kiidetud

Otsuse tegemise kuupäev

Ravimi nimetus

Rahvusvahe-line mittekauban-duslik nimetus

(INN)

Müügiloa omanik

Kande number ühenduse registris

Ravimvorm

ATC-kood

(anatoomilis-terapeutiline keemiline kood)

Teatamise kuupäev

19.1.2006

Kiovig

Inimese normaalne immunoglobuliin (IVIg)

Baxter AG, Industriestraße 67, A-1220 Vienna

EU/1/05/329/001-005

Infusioonilahus

J06BA02

23.1.2006

19.1.2006

Yttriga

Ütrium (90Y) -kloriid

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

EU/1/05/322/001

Radiofarmatseutiline eelpreparaat, lahus

taotlusel

23.1.2006

19.1.2006

CUBICIN

daptomütsiin

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

EU/1/05/328/001-002

pulber infusioonilahuse kontsentraadi valmistamiseks

taotlusel

23.1.2006

24.1.2006

Naglazyme

Rekombinantne inimese N-atsetüülgalaktosamiini 4-sulfataas (galsulfaas)

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

EU/1/05/324/001

Kontsentraat infusioonilahuse valmistamiseks

A16AB

26.1.2006

24.1.2006

Ionsys

Fentanüül

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

EU/1/05/326/001

Iontoforeetiline transdermaalne süsteem

N02A B03

26.1.2006

24.1.2006

Exubera

Humaaninsuliin

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

EU/1/05/327/001-017

Inhalatsioonipulber, eelnevalt annustatud

taotlusel

26.1.2006

31.1.2006

Macugen

pegaptaniibnaatriumi

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

EU/1/05/325/001

Süstelahus

S01XA17

2.2.2006

—   Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Heaks kiidetud

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

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

—   Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 38): Heaks kiidetud

Otsuse tegemise kuupäev

Ravimi nimetus

Müügiloa omanik

Kande number ühenduse registris

Teatamise kuupäev

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

Kõnealuseid ravimeid käsitleva avaliku hindamisaruandega ja vastavate otsustega tutvuda soovijatel palutakse pöörduda:

The European Medicines Agency (Euroopa Ravimiamet)

7, Westferry Circus, Canary Wharf

London E14 4HB

United Kingdom

(1)  ELT L 136, 30.4.2004, lk 1.

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