Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/09/653   
Active ingredient: Eculizumab
Indication: Treatment of atypical haemolytic uremic syndrome
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
28/07/2009 Orphan designation EMEA/OD/027/09 (2009)6029 of 24/07/2009
15/10/2009 Change of name and/or address of sponsor
20/02/2015 Change of name and/or address of sponsor