Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zevalin   
Auth. number : EU/1/03/264
Active substance : Ibritumomab tiuxetan
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V10 - Therapeutic radiopharmaceuticals
Pharmacological subgroup: V10X - Other therapeutic radiopharmaceuticals
Chemical subgroup: V10XX - Various therapeutic radiopharmaceuticals
Chemical substance: V10XX02 - Ibritumomab tiuxetan
(See WHO ATC Index)
Indication: Zevalin is indicated in adults. [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

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 is available in the Community Register.

European Commission proceduresGoto top of the page

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 (no change in Commission Decision) EMEA/H/C/547/II/2
22/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/547/II/1
07/10/2004 Centralised - Notification 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 (no change in Commission Decision) EMEA/H/C/547/II/4
27/03/2006 Centralised - Annual reassessment EMEA/H/C/547/S/9
03/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/547/II/10
23/10/2006 Centralised - Variation EMEA/H/C/547/II/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 (no change in Commission Decision) EMEA/H/C/547/II/16
18/10/2007 Centralised - Variation EMEA/H/C/547 (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 (no change in Commission Decision) 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 (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/547/IA/25/G
29/10/2010 Centralised - Notification EMEA/H/C/547/N/27
Updated with Decision(2011)6167 of 24/08/2011
11/01/2011 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/547/IB/29/G
14/04/2011 Centralised - Variation (no change in Commission Decision) 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
Updated with Decision(2014)1862 of 14/03/2014
30/04/2013 Centralised - Variation EMEA/H/C/IA/38
Updated with Decision(2014)1862 of 14/03/2014
08/05/2013 Centralised - Variation EMEA/H/C/547/IB/37
Updated with Decision(2014)1862 of 14/03/2014
18/03/2014 Centralised - Yearly update (2014)1862 of 14/03/2014
25/04/2014 Centralised - Variation EMEA/H/C/547/II/39
Updated with Decision(2015)2618 of 15/04/2015