TASIGNA 200 MG
NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) : 200 MG · DIN 02315874 · NOVARTIS PHARMACEUTICALS CANADA INC
Health Canada status: MARKETED
What is TASIGNA?
TASIGNA 200 MG contains NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02315874, held by NOVARTIS PHARMACEUTICALS CANADA INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 30-Sep-2008. 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 TASIGNA used for?
Treatment of adult and pediatric patients (2+) with newly diagnosed Ph+ CML-CP; adult Ph+ CML-CP/AP and pediatric Ph+ CML-CP resistant/intolerant to prior therapy including imatinib.
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 | 02315874 |
|---|---|
| Brand name | TASIGNA |
| Generic / active ingredient | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) : 200 MG |
| Manufacturer | NOVARTIS PHARMACEUTICALS CANADA INC |
| Strength | 200 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L01EA03 NILOTINIB |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 30-Sep-2008 |
| Original market date | 2008-09-30 00:00:00 |
How is it administered?
Adults: 300mg or 400mg BID. Pediatrics: 230mg/m2 BID. Take on empty stomach (no food 2h before/1h after). Swallow whole or disperse in 1 tsp applesauce. Dose adjustments for toxicity.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refer to section 11).
How is it supplied?
Not explicitly detailed in provided text (mentions 150 mg and 200 mg strengths).
Contraindications
Known long QTc prolongation (> 480 msec); uncorrectable hypokalemia or hypomagnesemia; known hypersensitivity to nilotinib or any excipients.
Warnings and precautions
Sudden cardiac death, QT prolongation, ischemic heart disease, PAOD, hepatotoxicity, pancreatitis, myelosuppression, and tumor lysis syndrome.
What can be used instead?
Other Canadian products sharing ATC code L01EA03 NILOTINIB. 6 of 8 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 |
|---|---|---|---|---|---|
| APO-NILOTINIB | 150 MG | CAPSULE | APOTEX INC | MARKETED | DIN 02550881 |
| APO-NILOTINIB | 200 MG | CAPSULE | APOTEX INC | MARKETED | DIN 02550903 |
| REDDY-NILOTINIB | 150 MG | CAPSULE | DR REDDY'S LABORATORIES LTD | MARKETED | DIN 02556634 |
| REDDY-NILOTINIB | 200 MG | CAPSULE | DR REDDY'S LABORATORIES LTD | MARKETED | DIN 02556642 |
| TASIGNA | 150 MG | CAPSULE | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02368250 |
| REDDY-NILOTINIB | 50 MG | CAPSULE | DR REDDY'S LABORATORIES LTD | APPROVED | DIN 02556626 |
| TASIGNA | 50 MG | CAPSULE | NOVARTIS PHARMACEUTICALS CANADA INC | CANCELLED POST MARKET | DIN 02481715 |
Who else supplies NILOTINIB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. NILOTINIB appears in 113 registered pack listings across 13 markets, published on 11 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.