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Pharmaceuticals - Union Register
Union Register of medicinal products for human use |
AUTHORISED |
Product information |
Invented name: | Raxone
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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 procedures |
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 |