Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Defibrotide

EU orphan designation number: EU/3/04/212   
Active ingredient: Defibrotide
Indication: Treatment 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 Centralised Orphan - Designation EMEA/OD/026/04 (2004)3000 of 29/07/2004