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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/01/082
Active ingredient: 2-chloro-9-[2-deoxy-2-fluoro-ß-D-arabinofuranosyl]adenine
Indication: Treatment of acute lymphoblastic leukaemia
Sponsor: Genzyme Europe B.V.
Gooimeer 10, 1411 DD Naarden, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Evoltra on 29/05/2006 with the number EU/1/06/334

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
07/02/2002 Orphan designation EMEA/OD/046/01 (2002)478 of 05/02/2002
03/12/2002 Transfer of orphan designation EMEA/OD/046/01/T/01 (2002)4762 of 02/12/2002
22/12/2006 Change of name and/or address of sponsor EMEA/OD/046/01
27/05/2008 Transfer of orphan designation EMEA/OD/046/01/T/02 (2008)2289 of 23/05/2008
31/05/2016 Removal of orphan designation from Community Register