Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/04/211   
Active ingredient: Defibrotide
Indication: Prevention of hepatic veno-occlusive disease
Sponsor: Gentium S.p.A.
Piazza XX Settembre, 2, I-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/025/04 (2004)3013 of 29/07/2004