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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)
Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 1.1.2006. līdz 31.1.2006. (Publicēts atbilstīgi 13. pantam vai 38. pantam Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004
Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 1.1.2006. līdz 31.1.2006. (Publicēts atbilstīgi 13. pantam vai 38. pantam Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004
OV 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 |
LV |
Eiropas Savienības Oficiālais Vēstnesis |
C 46/21 |
Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 1.1.2006. līdz 31.1.2006.
(Publicēts atbilstīgi 13. pantam vai 38. pantam Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 (1)
(2006/C 46/03)
— Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) No726/2004): Pieņemts
|
Lēmuma datums |
Zāļu nosaukums |
SNN (Starptautiskais nepatentētais nosaukums) |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Farmaceitiskā forma |
ATĶ kods (Anatomiski terapeitiski ķīmiskais kods) |
Paziņojuma datums |
|
19.1.2006. |
Kiovig |
Immunoglobulinum humanum normale (cilvēka normālais imūnglobulīns) (IVIg) |
Baxter AG, Industriestraße 67, A-1220 Vienna |
EU/1/05/329/001-005 |
Šķīdums intravenozām infūzijām |
J06BA02 |
23.1.2006. |
|
19.1.2006. |
Yttriga |
Itrija (90Y) hlorīds |
AEA Technology QSA GmbH, Gieselweg 1, D-38110 Braunschweig |
EU/1/05/322/001 |
radiofarmaceitisks prekursors, šķīdums |
vēl nav piešķirts |
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 |
pulveris koncentrāta pagatavošanai infūziju šķīdumam |
vēl nav piešķirts |
23.1.2006. |
|
24.1.2006. |
Naglazyme |
Cilvēka N-acetilgalaktozamīna 4-sulfatāzes rekombinants (galsulfase) |
BioMarin Europe Limited, 29, Earlsfort Terrace, Dublin 2, Ireland |
EU/1/05/324/001 |
koncentrāts infūzijas šķīduma pagatavošanai |
A16AB |
26.1.2006. |
|
24.1.2006. |
Ionsys |
Fentanyl |
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse |
EU/1/05/326/001 |
Transdermāla jonoforēzes sistēma |
N02A B03 |
26.1.2006. |
|
24.1.2006. |
Exubera |
Cilvēka insulīns |
Aventis/Pfizer EEIG, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/05/327/001-017 |
inhalācijas pulveris, iepriekš dalīts |
vēl nav piešķirts |
26.1.2006. |
|
31.1.2006. |
Macugen |
Pegaptaniba nātrija sāls |
Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/05/325/001 |
Šķīdums injekcijai |
S01XA17 |
2.2.2006. |
— Tirdzniecības atļaujas izmaiņas (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemts
|
Lēmuma datums |
Zāļu nosaukums |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Paziņojuma datums |
|
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. |
— Tirdzniecības atļaujas izmaiņas (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemts
|
Lēmuma datums |
Zāļu nosaukums |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Paziņojuma datums |
|
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. |
Ja vēlaties apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, lūdzam sazināties ar
|
The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
|
London E14 4HB |
|
United Kingdom |
(1) OV L 136, 2004. gada 30. aprīlis, 1. lpp.