Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/06/370   
Active ingredient: Decitabine
Indication: Treatment of acute myeloid leukaemia
Sponsor: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Dacogen on 20/09/2012 with the number EU/1/12/792

   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
19/07/2006 Orphan designation EMEA/OD/004/06 (2006)2306 of 08/06/2006
01/09/2006 Change of name and/or address of sponsor
05/03/2007 Transfer of orphan designation EMEA/OD/004/06/T/01 (2007)759 of 01/03/2007
02/08/2012 Other procedure