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Dokument 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)
Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. januarja 2006 do 31. januarja 2006 (Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)
Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. januarja 2006 do 31. januarja 2006 (Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)
UL C 46, 24.2.2006, lk 21—24
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
24.2.2006 |
SL |
Uradni list Evropske unije |
C 46/21 |
Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. januarja 2006 do 31. januarja 2006
(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1))
(2006/C 46/03)
— Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta: Odobrena
|
Datum sprejetja odločbe |
Ime zdravila |
INN (mednarodno nelastniško ime) |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Farmacevtska oblika |
Oznaka ATC (anatomsko terapevtsko kemijska oznaka) |
Datum obvestila |
|
19.1.2006 |
Kiovig |
Humani normalni imunoglobulin (i.v. Ig) |
Baxter AG, Industriestraße 67, A-1220 Vienna |
EU/1/05/329/001-005 |
Raztopina za intravensko infundiranje |
J06BA02 |
23.1.2006 |
|
19.1.2006 |
Yttriga |
Itrijev (90Y) klorid |
AEA Technology QSA GmbH, Gieselweg 1, D-38110 Braunschweig |
EU/1/05/322/001 |
Radiofarmacevtska predhodna sestavina, raztopina |
v teku |
23.1.2006 |
|
19.1.2006 |
CUBICIN |
daptomicin |
Chiron Corporation Limited, Symphony House, 7 Cowley Business Park, High Street, Cowley, UXBRIDGE, UB8 2AD, United Kingdom |
EU/1/05/328/001-002 |
prašek za koncentrat za pripravo raztopine za infundiranje |
v teku |
23.1.2006 |
|
24.1.2006 |
Naglazyme |
Rekombinantna humana N-acetilgalaktozamin-4-sulfataza (galsulfaza) |
BioMarin Europe Limited, 29, Earlsfort Terrace, Dublin 2, Ireland |
EU/1/05/324/001 |
Koncentrat za pripravo raztopine za infundiranje |
A16AB |
26.1.2006 |
|
24.1.2006 |
Ionsys |
Fentanil |
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse |
EU/1/05/326/001 |
Iontoforetski transdermalni sistem |
N02A B03 |
26.1.2006 |
|
24.1.2006 |
Exubera |
Humani insulin |
Aventis/Pfizer EEIG, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/05/327/001-017 |
Prašek za inhaliranje, odmerjen |
v teku |
26.1.2006 |
|
31.1.2006 |
Macugen |
Natrijev pegaptanib |
Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/05/325/001 |
Raztopina za injiciranje |
S01XA17 |
2.2.2006 |
— Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja odločbe |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
|
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 |
— Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja odločbe |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
|
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 |
Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih odločb zdravil, se lahko obrne na naslov:
|
The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
|
LONDON E14 4HB |
|
United Kingdom |
(1) UL L 136, 30.4.2004, str. 1.