Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/07/434   
Active ingredient: Idebenone
Indication: Treatment of Leber's hereditary optic neuropathy
Sponsor: Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Straße 8, 79539 Lörrach, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Raxone on 8/09/2015 with the number EU/1/15/1020

   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
20/02/2007 Orphan designation EMEA/OD/076/06 (2007)539 of 15/02/2007
28/05/2015 Change of name and/or address of sponsor
16/07/2015 Other procedure
13/04/2016 Change of name and/or address of sponsor