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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Zevalin
|
| Auth. number : | EU/1/03/264 |
| INN : | Ibritumomab tiuxetan |
| ATC: | V - Various V10 - Therapeutic radiopharmaceuticals V10X - Other therapeutic radiopharmaceuticals V10XX - Various therapeutic radiopharmaceuticals V10XX02 - Ibritumomab tiuxetan (See WHO ATC Index) |
| Indication: | [90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL). |
| Marketing Authorisation Holder: | Spectrum Pharmaceuticals B.V.
Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information". Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 22/01/2004 | Centralised - Authorisation | EMEA/H/C/547 | (2004)119 of 16/01/2004 | |||
| 22/09/2004 | Centralised - Variation | EMEA/H/C/547/II/2 | ||||
| 22/09/2004 | Centralised - Variation | EMEA/H/C/547/II/1 | ||||
| 07/10/2004 | Centralised - Variation | EMEA/H/C/547/N/3 | ||||
| Updated with Decision(2005)2744 of 08/07/2005 | ||||||
| 07/02/2005 | Centralised - Variation | EMEA/H/C/547/IB/5 | ||||
| Updated with Decision(2005)2744 of 08/07/2005 | ||||||
| 11/07/2005 | Centralised - Annual reassessment | EMEA/H/C/547/S/7 | (2005)2744 of 08/07/2005 | |||
| 29/07/2005 | Centralised - Variation | EMEA/H/C/547/II/6 | (2005)2966 of 27/07/2005 | |||
| 18/11/2005 | Centralised - Variation | EMEA/H/C/547/II/8 | (2005)4499 of 15/11/2005 | |||
| 20/12/2005 | Centralised - Variation | EMEA/H/C/547/II/4 | ||||
| 27/03/2006 | Centralised - Annual reassessment | EMEA/H/C/547/S/9 | ||||
| 03/07/2006 | Centralised - Variation | EMEA/H/C/547/II/10 | ||||
| 23/10/2006 | Centralised - Variation | EMEA/H/C/547/I/12 | (2006)5079 of 19/10/2006 | |||
| 16/11/2006 | Centralised - Variation | EMEA/H/C/547/II/11 | (2006)5548 of 14/11/2006 | |||
| 16/03/2007 | Centralised - Variation | EMEA/H/C/547/IA/15 | ||||
| Updated with Decision(2007)5153 of 15/10/2007 | ||||||
| 26/03/2007 | Centralised - Annual reassessment | EMEA/H/C/547/S/14 | ||||
| 31/05/2007 | Centralised - Variation | EMEA/H/C/547/II/16 | ||||
| 18/10/2007 | Centralised - Variation | - | (2007)5153 of 15/10/2007 | |||
| 24/10/2007 | Centralised - Variation | EMEA/H/C/547/II/17 | (2007)5249 of 22/10/2007 | |||
| 14/01/2008 | Centralised - Variation | EMEA/H/C/547/IB/19 | ||||
| Updated with Decision(2008)1630 of 18/04/2008 | ||||||
| 22/04/2008 | Centralised - Variation | EMEA/H/C/547/II/18 | (2008)1630 of 18/04/2008 | |||
| 05/05/2008 | Centralised - Variation | EMEA/H/C/547/II/20 | ||||
| 27/05/2008 | Centralised - Annual reassessment | EMEA/H/C/547/S/21 | (2008)2241 of 22/05/2008 | |||
| 12/01/2009 | Centralised - Renewal | EMEA/H/C/547/R/22 | (2009)53 of 07/01/2009 | |||
| 27/02/2009 | Centralised - Variation | EMEA/H/C/547/II/23 | ||||
| 07/09/2009 | Centralised - Variation | EMEA/H/C/547/II/24 | (2009)6881 of 04/09/2009 | |||
| 03/08/2010 | Centralised - Variation | EMEA/H/C/547/IA/25/G | ||||
| 29/10/2010 | Centralised - Variation | EMEA/H/C/547/N/27 | ||||
| Updated with Decision(2011)6167 of 24/08/2011 | ||||||
| 11/01/2011 | Centralised - Variation | EMEA/H/C/547/IA/30/G | ||||
| 19/01/2011 | Centralised - Variation | EMEA/H/C/547/IB/28 | ||||
| Updated with Decision(2011)6167 of 24/08/2011 | ||||||
| 20/01/2011 | Centralised - Variation | EMEA/H/C/547/IB/29/G | ||||
| 14/04/2011 | Centralised - Variation | EMEA/H/C/547/II/26 | ||||
| 03/08/2011 | Centralised - Variation | EMEA/H/C/547/IA/31/G | ||||
| Updated with Decision(2011)8255 of 10/11/2011 | ||||||
| 30/08/2011 | Centralised - Variation | - | (2011)6167 of 24/08/2011 | |||
| 15/11/2011 | Centralised - Variation | - | (2011)8255 of 10/11/2011 | |||
| 04/12/2012 | Centralised - Transfer Marketing Authorisation Holder | EMEA/H/C/547/T/33 | (2012)9092 of 30/11/2012 | |||
| 03/04/2013 | Centralised - Variation | EMEA/H/C/547/IAIN/35/G | ||||