Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Idebenone

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 8, 79539 Lörrach, Deutschland

   Public summary of scientific opinion    

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 8/03/2004
3/01/2006 Transfer of orphan designation EMEA/OD/082/03/T/01 (2005)5978 of 23/12/2005
9/11/2010 Change of name and/or address of sponsor EMEA/69414/2005
28/05/2015 Change of name and/or address of sponsor
13/04/2016 Change of name and/or address of sponsor