Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/04/212   
Active ingredient: Defibrotide
Indication: Treatment of hepatic veno-occlusive disease
Sponsor: Gentium S.r.I.
Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Defitelio on 18/10/2013 with the number EU/1/13/878

   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
02/08/2004 Orphan designation EMEA/OD/026/04 (2004)3000 of 29/07/2004
04/09/2013 Other procedure
18/01/2016 Change of name and/or address of sponsor