Pharmaceuticals - Union Register


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
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, 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 Orphan designation EMEA/OD/042/03 (2003)3940 of 17/10/2003
28/03/2006 Transfer of orphan designation EMEA/OD/042/03/T/01 (2006)1109 of 23/03/2006
15/10/2009 Change of name and/or address of sponsor
20/02/2015 Change of name and/or address of sponsor