Raxone (idebenone)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- idebenone
- Company
- Chiesi Farmaceutici S.p.A
- Status
- Authorised
- Therapeutic area
- Optic Atrophy, Hereditary, Leber
- CHMP opinion
- Thu 25 Jun 2015
- EU approval
- Tue 08 Sep 2015
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/003834
- ATC
- N06BX13
- Official record
- www.ema.europa.eu
Indication
Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Puldysa Application withdrawn · Santhera Pharmaceuticals (Deutschland) GmbH
- 🇪🇺 Raxone Application withdrawn · Santhera Pharmaceuticals (Deutschland) GmbH
- 🇪🇺 Sovrima Refused · Centocor B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.