Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/13/1201   
Active ingredient: Defibrotide
Indication: Prevention of graft-versus-host disease
Sponsor: Gentium S.r.I.
Piazza XX Settembre, 2, 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
15/11/2013 Orphan designation EMA/OD/103/13 (2013)8047 of 13/11/2013
18/01/2016 Change of name and/or address of sponsor