Indications
The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Composition
- Active substance
- omaveloxolone
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Medicine
- Skyclarys
- Active substance
- omaveloxolone
- ATC code
- N07XX25
- Group
- Nervous system
- Therapeutic area
- Friedreich Ataxia
- Marketing authorisation holder
- Biogen Netherlands B.V.
- Status
- Authorised
- EU authorisation
- 9 Feb 2024
- EMA product number
- EMEA/H/C/006084