TAFINLAR 50 MG
DABRAFENIB (DABRAFENIB MESYLATE) : 50 MG · DIN 02409607 · NOVARTIS PHARMACEUTICALS CANADA INC
Health Canada status: MARKETED
What is TAFINLAR?
TAFINLAR 50 MG contains DABRAFENIB (DABRAFENIB MESYLATE) : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02409607, held by NOVARTIS PHARMACEUTICALS CANADA INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 27-Sep-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 TAFINLAR used for?
Treatment of BRAF V600 mutation-positive: unresectable/metastatic melanoma, adjuvant melanoma, metastatic NSCLC, and pediatric LGG/HGG (1 year+). Not for BRAF wild-type tumors.
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 | 02409607 |
|---|---|
| Brand name | TAFINLAR |
| Generic / active ingredient | DABRAFENIB (DABRAFENIB MESYLATE) : 50 MG |
| Manufacturer | NOVARTIS PHARMACEUTICALS CANADA INC |
| Strength | 50 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L01EC02 DABRAFENIB |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 27-Sep-2016 |
| Original market date | 2013-08-28 00:00:00 |
How is it administered?
Adults: 150 mg twice daily. Pediatrics: Weight-based dosing. Take without food at least 1 hour before or 2 hours after a meal. Capsules must be swallowed whole; tablets for suspension only.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text snippet (refers to section 11), but mentions silica gel desiccant for stability.
How is it supplied?
50 mg and 75 mg capsules: Bottles of 120. 10 mg tablets for suspension: Bottles of 210. Contains silica gel desiccant.
Contraindications
Hypersensitivity to dabrafenib or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Serious: Secondary malignancies, non-infectious febrile events, venous thromboembolism, major hemorrhage. Teratogenic. Not for BRAF wild-type tumors.
What can be used instead?
Other Canadian products sharing ATC code L01EC02 DABRAFENIB. 3 of 3 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| TAFINLAR | 10 MG | TABLET FOR SUSPENSION | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02540053 |
| TAFINLAR | 75 MG | CAPSULE | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02409615 |
Who else supplies DABRAFENIB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. DABRAFENIB appears in 52 registered pack listings across 12 markets, published on 9 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.