Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Evoltra   
Auth. number : EU/1/06/334
Active substance : clofarabine
Orphan market exclusivity for "Treatment of acute lymphoblastic leukaemia" (based on designation EU/3/01/082) started on 31/05/2006
   10 years of market exclusivity
   This orphan market exclusivity will expire on 31/05/2016
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01B - Antimetabolites
Chemical subgroup: L01BB - Purine analogues
Chemical substance: L01BB06 - Clofarabine
(See WHO ATC Index)
Indication: Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis
Marketing Authorisation Holder: Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, 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
31/05/2006 Centralised - Authorisation EMEA/H/C/613 (2006)2183 of 29/05/2006
24/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/II/2
31/08/2007 Centralised - Variation EMEA/H/C/613/II/3 (2007)4105 of 29/08/2007
21/01/2008 Centralised - Annual reassessment EMEA/H/C/613/S/4 (2008)292 of 17/01/2008
06/06/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/613/T/5 (2008)2596 of 04/06/2008
27/08/2008 Centralised - Notification EMEA/H/C/613/N/6
Updated with Decision(2009)1289 of 20/02/2009
24/02/2009 Centralised - Annual reassessment EMEA/H/C/613/S/7 (2009)1289 of 20/02/2009
05/05/2009 Centralised - Variation EMEA/H/C/613/II/8, 9 (2009)3451 of 29/04/2009
19/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/IA/12
19/05/2009 Centralised - Variation EMEA/H/C/613/IB/11
Updated with Decision(2009)10239 of 10/12/2009
26/06/2009 Centralised - Variation EMEA/H/C/613/IA/13
Updated with Decision(2009)10239 of 10/12/2009
17/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/IB/14
14/12/2009 Centralised - Variation (2009)10239 of 10/12/2009
17/03/2010 Centralised - Annual reassessment EMEA/H/C/613/S/15 (2010)1785 of 15/03/2010
23/03/2010 Centralised - Variation EMEA/H/C/613/II/16 (2010)1948 of 19/03/2010
22/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/IA/20
28/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/II/19
28/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/II/18
06/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/IA/24
18/10/2010 Centralised - Variation (refusal) EMEA/H/C/613/IA/21
18/10/2010 Centralised - Variation (refusal) EMEA/H/C/613/IA/22
18/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/IA/26
18/10/2010 Centralised - Variation (refusal) EMEA/H/C/613/IA/23
18/10/2010 Centralised - Variation (refusal) EMEA/H/C/613/IA/25
10/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/IA/28
23/02/2011 Centralised - Variation (refusal) EMEA/H/C/613/IA/29
24/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/613/IA/30/G
30/03/2011 Centralised - Renewal EMEA/H/C/613/R/27 (2011)2091 of 24/03/2011
23/11/2011 Centralised - Variation EMEA/H/C/613/II/31 (2011)8644 of 21/11/2011
26/03/2012 Corrigendum (2011)2091 of 21/03/2012
17/04/2012 Centralised - Annual reassessment EMEA/H/C/613/S/33 (2012)2547 of 13/04/2012
07/05/2012 Centralised - Notification EMEA/H/C/613/N/35
Updated with Decision(2014)7545 of 10/10/2014
05/07/2012 Centralised - Notification EMEA/H/C/613/N/36
Updated with Decision(2014)7545 of 10/10/2014
24/10/2013 Centralised - Variation EMEA/H/C/613/II/39
Updated with Decision(2014)7545 of 10/10/2014
15/01/2014 Centralised - Notification EMEA/H/C/613/N/40
Updated with Decision(2014)7545 of 10/10/2014
20/03/2014 Centralised - Annual reassessment EMEA/H/C/613/S/41
25/04/2014 Centralised - Variation EMEA/H/C/613/II/42
Updated with Decision(2014)7545 of 10/10/2014
14/10/2014 Centralised - Yearly update (2014)7545 of 10/10/2014
21/11/2014 PSUSA - Modification EMEA/H/C/613/PSUV/44 (2014)8888 of 19/11/2014
18/03/2015 Centralised - Annual reassessment EMEA/H/C/613/S/45 (2015)1912 of 16/03/2015