MYLOTARG 4.5 MG — DIN 02494388
GEMTUZUMAB OZOGAMICIN : 4.5 MG · PFIZER CANADA ULC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is MYLOTARG?
MYLOTARG 4.5 MG contains GEMTUZUMAB OZOGAMICIN : 4.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02494388, held by PFIZER CANADA ULC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 11-Mar-2020. 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 MYLOTARG used for?
Mylotarg (gemtuzumab ozogamicin for injection) is indicated for: • Combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients with previously untreated, de novo CD33 - positive acute myeloid leukemia (AML), except acute promyelocytic leukemia
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 | 4.5 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Each carton contains 1 vial. |
| Storage | Reconstituted solution: up to 16 hours in a refrigerator (2°C - 8°C) or up to 3 hours at room temperature (below 30°C). Protect from light and do not freeze. Diluted solution: up to 18 hours in a refrigerator (2 - 8°C) and up to 6 hours at room temperature (below 30°C). Protect from light and do not freeze. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Gemtuzumab Ozogamicin |
|---|---|
| ATC code | L01FX02 |
| AHFS class | 10:00.00 |
| 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) | 02494388 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2494388 |
| Brand name | MYLOTARG |
| Generic / active ingredient | GEMTUZUMAB OZOGAMICIN : 4.5 MG |
| Market authorization holder | PFIZER CANADA ULC |
| Health Canada schedule | Prescription |
| ATC code | L01FX02 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01FX |
| Current status | MARKETED |
| Status date | 11-Mar-2020 |
| Original market date | 2020-03-11 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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 L01FX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Polatuzumab Vedotin | POLIVY | 2 | 2 | Yes |
| Teclistamab | TECVAYLI | 2 | 2 | Yes |
| Belantamab Mafodotin | BLENREP | 2 | 2 | Yes |
| Glofitamab | COLUMVI | 2 | 2 | Yes |
| Talquetamab | TALVEY | 2 | 2 | Yes |
| Tarlatamab | IMDELLTRA | 2 | 2 | Yes |
| Elranatamab | ELREXFIO | 2 | 2 | Yes |
| Enfortumab Vedotin | PADCEV | 2 | 2 | Yes |
| Epcoritamab | EPKINLY | 2 | 2 | Yes |
| Blinatumomab | BLINCYTO | 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.
3 · Adjacent classes in ATC L01F
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01FD | Pertuzumab · Trastuzumab · Trastuzumab Deruxtecan · Trastuzumab Emtansine | 18 | 16 |
| L01FG | Bevacizumab · Ramucirumab | 14 | 14 |
| L01FF | Atezolizumab · Avelumab · Cemiplimab · Dostarlimab · Durvalumab · +3 more | 14 | 12 |
| L01FA | Obinutuzumab · Ofatumumab · Rituximab | 11 | 8 |
| L01FC | Daratumumab · Isatuximab | 5 | 5 |
| L01FY | Nivolumab And Relatlimab · Pertuzumab And Trastuzumab | 4 | 4 |
| L01FE | Cetuximab · Necitumumab · Panitumumab | 5 | 3 |
| L01FB | Inotuzumab Ozogamicin | 1 | 1 |
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.