Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/01/084   
Active ingredient: Azacitidine
Indication: Treatment of myelodysplastic syndromes
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
08/03/2002 Orphan designation EMEA/OD/059/01 (2002)490 of 06/02/2002
25/07/2005 Change of name and/or address of sponsor
31/10/2008 Transfer of orphan designation EMEA/OD/059/01/T/01 (2008)6535 of 29/10/2008
30/05/2011 Change of name and/or address of sponsor EMEA/OD/059/01