Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/00/012
Active ingredient: nitisinone
Indication: Treatment of tyrosinaemia type I
Sponsor: Swedish Orphan Biovitrum International AB
112 76 Stockholm, Sverige
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Orfadin on 21/02/2005 with the number EU/1/04/303

   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
30/01/2001 Orphan designation EMEA/OD/011/00 (2000)4047 of 29/12/2000
06/08/2013 Change of name and/or address of sponsor
24/02/2015 Removal of orphan designation from Community Register