Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Raxone   
Auth. number : EU/1/15/1020
Active substance : idebenone
Orphan market exclusivity for "Treatment of Leber's hereditary optic neuropathy" (based on designation EU/3/07/434) started on 10/09/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 10/09/2025
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06B - Psychostimulants
Chemical subgroup: N06BX - Other psychostimulants
Chemical substance: N06BX13 - idebenone
(See WHO ATC Index)
Indication: Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).
Marketing Authorisation Holder: Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Straße 8, 79539 Lörrach, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/09/2015 Centralised - Authorisation EMEA/H/C/3834 (2015)6261 of 8/09/2015
12/08/2016 Centralised - Variation EMEA/H/C/3834/IA/4
Updated with Decision(2017)5241 of 19/07/2017
21/04/2017 Centralised - Annual reassessment EMEA/H/C/3834/S/5
24/07/2017 Centralised - Yearly update (2017)5241 of 19/07/2017
22/02/2018 Centralised - Annual reassessment EMEA/H/C/3834/S/9
8/03/2018 Centralised - Variation EMEA/H/C/3834/II/8
Updated with Decision(2019)1074 of 07/02/2019
11/12/2018 Centralised - Notification EMEA/H/C/3834/N/14
Updated with Decision(2019)1074 of 07/02/2019
11/02/2019 Centralised - Yearly update (2019)1074 of 7/02/2019