Pharmaceuticals - Community Register

  

List of refusals for human medicinal products

Raxone

Product name: Raxone
INN: idebenone
Indication: Raxone is indicated in patients 14 years of age and older with Leber’s Hereditary Optic Neuropathy (LHON) presenting for treatment within one year of onset of symptoms
Marketing Authorisation Holder: Santhera Pharmaceuticals (Deutschland) GmbH

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
04/06/2013 Centralised - Refusal of marketing authorisation EMEA/H/C/2425 (2013)3422 of 31/05/2013