SKYCLARYS 50 MG — DIN 02556219
OMAVELOXOLONE : 50 MG · BIOGEN CANADA INC · CAPSULE · wholesale supply in Canada
Health Canada status: MARKETED
What is SKYCLARYS?
SKYCLARYS 50 MG contains OMAVELOXOLONE : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02556219, held by BIOGEN CANADA INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 29-May-2025. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is SKYCLARYS used for?
Treatment of Friedreich’s ataxia in patients 16 years of age and older.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 50 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | High-density polyethylene bottles with child-resistant, foil induction seal closure. Pack size of 90 capsules. |
| Storage | Not explicitly specified in provided text (Section 11 listed in TOC but content not in snippet). Standard practice is 15-30°C. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Other Nervous System Drugs |
|---|---|
| ATC code | N07XX |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02556219 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2556219 |
| Brand name | SKYCLARYS |
| Generic / active ingredient | OMAVELOXOLONE : 50 MG |
| Market authorization holder | BIOGEN CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | N07XX |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N07XX |
| Current status | MARKETED |
| Status date | 29-May-2025 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Recommended dose is 150 mg (3 capsules) once daily on an empty stomach (1h before or 2h after eating). Swallow whole; can be sprinkled on applesauce if unable to swallow.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Elevation of B-Type Natriuretic Peptide (BNP) and fluid overload; Elevation of LDL-C; Elevation of serum aminotransferases (ALT/AST); Weight loss.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
2 · Same class — other molecules in ATC N07XX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Fampridine | APO-FAMPRIDINE · FAMPYRA · PMS-FAMPRIDINE · TARO-FAMPRIDINE | 4 | 3 | Yes |
| Tetrabenazine | APO-TETRABENAZINE · NITOMAN · PMS-TETRABENAZINE · TETRABENAZINE TABLETS | 4 | 3 | Yes |
| Riluzole | APO-RILUZOLE · MYLAN-RILUZOLE · RILUTEK | 3 | 3 | Yes |
| Amifampridine | FIRDAPSE · RUZURGI | 2 | 2 | Yes |
| Hydroxybutyric Acid | XYREM · XYWAV | 2 | 2 | Yes |
| Pitolisant | WAKIX | 2 | 2 | Yes |
| Tafamidis | VYNDAMAX · VYNDAQEL | 2 | 2 | Yes |
| Edaravone | RADICAVA | 2 | 1 | Yes |
| Trofinetide | DAYBUE | 1 | 1 | Yes |
| Eplontersen | WAINUA | 1 | 1 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.