Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/07/509   
Active ingredient: Azacitidine
Indication: Treatment of acute myeloid leukaemia
Sponsor: Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Vidaza on 17/12/2008 with the number EU/1/08/488

   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
03/12/2007 Orphan designation EMEA/OD/085/07 (2007)6019 of 29/11/2007
23/10/2008 Transfer of orphan designation EMEA/OD/085/07/T/01 (2008)6245 of 21/10/2008
30/05/2011 Change of name and/or address of sponsor EMEA/OD/085/07