In other countries
The same active substances on other registers, the same brand first.
- SkyclarysBrazil · Biogen Brasil Produtos Farmaceuticos LtdaSame brand
- Skyclarys 50 MG Capsulas DurasSpain · 50 mg · cápsula dura · Biogen Netherlands B.V.Same brand
- SkyclarysEuropean Union · Biogen Netherlands B.V.Same brand
- SkyclarysCroatiaSame brand
- SkyclarysItaly · Capsula rigida · Biogen Netherlands BVSame brand
- Skyclarys 50 mg harde capsulesNetherlands · Capsule, hard · Biogen Netherlands B.V.Same brand
- SkyclarysUnited States · 50MG · capsule · Biogen USSame brand
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Health Canada, Canada
Health Canada, Drug Product Database, drugproduct API, entire response observed 2026-10-10T15:12:07.336870+00:00; native facts projected by Prognia.
Licence: Open Government Licence Canada · Added 13 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
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
- Active substance
- Omaveloxolone
- Strength
- 50 MG
- Dosage form
- Capsule
- Route
- Oral
- Register
- Canada (Health Canada)
- Status
- Marketed
- Authorised
- 29 May 2025
- Registration
- DIN 02556219
- Marketing authorisation holder
- Biogen Canada INC
- ATC code
- N07XX
- Group
- Nervous system
- Supply
- PRESCRIPTION