Pharmaceuticals - Community Register


List of refusals for human medicinal products

Raxone Refusal

Product name: Raxone Refusal
Active substance: 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

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Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
4/06/2013 Centralised - Refusal of marketing authorisation EMEA/H/C/2425 (2013)3422 of 31/05/2013