Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/14/1304   
Active ingredient: Eculizumab
Indication: Treatment of myasthenia gravis
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
31/07/2014 Orphan designation EMA/OD/062/14 (2014)5529 of 29/07/2014
20/02/2015 Change of name and/or address of sponsor