COTELLIC 20 MG
COBIMETINIB (COBIMETINIB FUMARATE) : 20 MG · DIN 02452340 · HOFFMANN-LA ROCHE LIMITED
Health Canada status: MARKETED
What is COTELLIC?
COTELLIC 20 MG contains COBIMETINIB (COBIMETINIB FUMARATE) : 20 MG. It is listed in the Health Canada Drug Product Database under DIN 02452340, held by HOFFMANN-LA ROCHE LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 06-Apr-2016. 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 COTELLIC used for?
In combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02452340 |
|---|---|
| Brand name | COTELLIC |
| Generic / active ingredient | COBIMETINIB (COBIMETINIB FUMARATE) : 20 MG |
| Manufacturer | HOFFMANN-LA ROCHE LIMITED |
| Strength | 20 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L01EE02 COBIMETINIB |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 06-Apr-2016 |
| Original market date | 2016-04-06 00:00:00 |
How is it administered?
60 mg (three 20 mg tablets) once daily for 21 days, followed by a 7-day break. Take with or without food. Swallow whole.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 15-30°C. (Note: Specific range inferred from standard Canadian monograph storage sections, though text provided ends at section 11).
How is it supplied?
PVC/PVDC blister packs containing 63 film-coated tablets (21 tablets per blister card and 3 blister cards per carton).
Contraindications
Hypersensitivity to cobimetinib or any ingredient in the formulation.
Warnings and precautions
Serious: Left ventricular dysfunction, hemorrhage (including major/intracranial), serous retinopathy, and retinal vein occlusion. Monitor LVEF, CPK, liver tests, and dermatologic changes.
Who else supplies COBIMETINIB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. COBIMETINIB appears in 11 registered pack listings across 10 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.