Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/03/166   
Active ingredient: Eculizumab
Indication: Treatment of paroxysmal nocturnal haemoglobinuria
Sponsor: Alexion Europe SAS
25 boulevard de l'Amiral Bruix, F-75016 Paris, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Soliris on 20/06/2007 with the number EU/1/07/393

   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
22/10/2003 Centralised Orphan - Designation EMEA/OD/042/03 (2003)3940 of 17/10/2003
28/03/2006 Centralised Orphan - Transfer of orphan designation EMEA/OD/042/03/T/01 (2006)1109 of 23/03/2006
15/10/2009 Other procedure