Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Defibrotide

EU orphan designation number: EU/3/04/211   
Active ingredient: Defibrotide
Indication: Prevention of hepatic veno-occlusive disease
Sponsor: Gentium S.r.I.
Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia

   Public summary of scientific opinion    

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
18/01/2016 Change of name and/or address of sponsor