Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/09/650   
Active ingredient: Blinatumomab
Indication: Treatment of acute lymphoblastic leukaemia
Sponsor: Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Blincyto on 23/11/2015 with the number EU/1/15/1047

   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
30/07/2009 Orphan designation EMEA/OD/029/09 (2009)6042 of 24/07/2009
31/01/2012 Change of name and/or address of sponsor EMEA/OD/029/09
19/06/2012 Change of name and/or address of sponsor EMEA/OD/029/09
17/02/2014 Transfer of orphan designation EMEA/OD/029/09/T/01 (2014)1082 of 13/02/2014