Sovrima (idebenone)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- idebenone
- Company
- Centocor B.V.
- Status
- Refused
- Therapeutic area
- Friedreich Ataxia
- CHMP opinion
- Thu 20 Nov 2008
- Designations
- Orphan
- Application
- EMEA/H/C/000908
- ATC
- N06BX13
- Official record
- www.ema.europa.eu
Indication
Treatment of Friedreichâ??s Ataxia
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Raxone Authorised · Chiesi Farmaceutici S.p.A
- 🇪🇺 Puldysa Application withdrawn · Santhera Pharmaceuticals (Deutschland) GmbH
- 🇪🇺 Raxone Application withdrawn · Santhera Pharmaceuticals (Deutschland) GmbH
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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.