APO-NILOTINIB 150 MG
NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) : 150 MG · DIN 02550881 · APOTEX INC
Health Canada status: MARKETED
What is APO-NILOTINIB?
APO-NILOTINIB 150 MG contains NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) : 150 MG. It is listed in the Health Canada Drug Product Database under DIN 02550881, held by APOTEX INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 13-Feb-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 APO-NILOTINIB used for?
APO-NILOTINIB (nilotinib) 150 mg and 200 mg capsules are indicated for: • The treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). • The treatment of pediatric patients 2 years of age and older with newly diagnosed Ph+ CML-CP. • The treatment of chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib. • The treatment of pediatric patients 2 years of age and older with Ph+ CML-CP with resistance or intolerance 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 | 02550881 |
|---|---|
| Brand name | APO-NILOTINIB |
| Generic / active ingredient | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) : 150 MG |
| Manufacturer | APOTEX INC |
| Strength | 150 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L01EA03 NILOTINIB |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 13-Feb-2025 |
How is it stored and handled?
null
How is it supplied?
null
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 | 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 |
| TASIGNA | 200 MG | CAPSULE | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | DIN 02315874 |
| 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.