Skyclarys
- Prescription status not stated
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Omaveloxolone
- Made by
- Biogen Netherlands B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (SKYCLARYS). It describes the substance, not this exact product.
The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich's ataxia is unknown.
Omaveloxolone has been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans.
Omaveloxolone is primarily metabolized by CYP3A with minor metabolism by CYP2C8 and CYP2J2.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-04-06
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Biogen Netherlands B.V. |
|---|---|
| Active substance | Omaveloxolone |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Classification | N07XX25 · Pain, sleep, mood, epilepsy and the brain |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2024-02-09 |
| Last updated by the regulator | 2026-08-19 |
| EMA product number | EMEA/H/C/006084 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).