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Skyclarys

Active substance: omaveloxolone

omaveloxolone

Centralised EU authorisationActive

Marketing holder: Biogen Netherlands B.V.

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 1
  • SKYCLARYS
    CAPSULE · OMAVELOXOLONE 50 mg/1
    64406-250
    Biogen
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12092-4874-70cf-ba74-78d7f68f9868;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/006084
Registration status
Active
ATC code
N07XX25
Sources
  • product · EMA · EMEA/H/C/006084 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/006084 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/006084 · Verified 2026-10-09