Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Reata Ireland Limited, Block A, Georges Quay Plaza, Georges Quay, Dublin 2, D02 E440 Ireland
Skyclarys 50 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Opaque hard capsule with “RTA 408” printed on the light green body in white ink and “50” printed on the blue cap in white ink. Capsules (size 0) are 21.7 ± 0.3 mm in length, and the outer diameter of the cap is 7.64 ± 0.06 mm. |
Each hard capsule contains 50 mg omaveloxolone.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Omaveloxolone |
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. The Nrf2 pathway is involved in the cellular response to oxidative stress. There is substantial evidence that Nrf2 levels and activity are suppressed in cells from patients with Friedreich’s ataxia. |
| List of Excipients |
|---|
|
Capsule contents: Pregelatinized maize starch Capsule shell: Hypromellose |
High density polyethylene bottles with child-resistant, foil induction-sealed polypropylene closure.
Pack size of 90 capsules.
Pack size of 270 (3 packs of 90) capsules.
Not all pack sizes may be marketed.
Reata Ireland Limited, Block A, George’s Quay Plaza, George’s Quay, Dublin 2, D02 E440 Ireland
EU/1/23/1786/001
EU/1/23/1786/002
| Drug | Countries | |
|---|---|---|
| SKYCLARYS | Austria, Estonia, France, Croatia, Lithuania, United States |
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