Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/04/189   
Active ingredient: Idebenone
Indication: Treatment of Friedreich’s ataxia
Sponsor: Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Strasse 24, D-79539 Lörrach, Deutschland

   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
10/03/2004 Orphan designation EMEA/OD/082/03 (2004)815 of 08/03/2004
03/01/2006 Transfer of orphan designation EMEA/OD/082/03/T/01 (2005)5978 of 23/12/2005
09/11/2010 Change name of sponsor EMEA/69414/2005
28/05/2015 Change of address of sponsor