Regulatory PathRegulatory requirements compared

Active substance

Idebenone

Open in the medicines table

EMA European Union — centrally authorised medicines

Raxone Chiesi Farmaceutici S.p.A · Authorised · authorised 8 Sep 2015 · ATC N06BX13

Therapeutic indication (EMA)

Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).

Sovrima Centocor B.V. · Refused · ATC N06BX13

Therapeutic indication (EMA)

Treatment of Friedreichâ??s Ataxia

Raxone Santhera Pharmaceuticals (Deutschland) GmbH · Application withdrawn · ATC N06BX13

Therapeutic indication (EMA)

Treatment of Lebers Hereditary Optic Neuropathy

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
RAXONE 150MG FILM COATED TABLETPLGB 08829/0204CHIESI LIMITEDPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffIdebenone 150mg tablets£6364.00180 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.