TEVA-TOPOTECAN 4 MG — DIN 02441071
TOPOTECAN (TOPOTECAN HYDROCHLORIDE) : 4 MG · TEVA CANADA LIMITED · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is TEVA-TOPOTECAN?
TEVA-TOPOTECAN 4 MG contains TOPOTECAN (TOPOTECAN HYDROCHLORIDE) : 4 MG. It is listed in the Health Canada Drug Product Database under DIN 02441071, held by TEVA CANADA LIMITED, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 09-Oct-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 TEVA-TOPOTECAN used for?
Metastatic carcinoma of the ovary after failure of initial or subsequent therapy; sensitive small cell lung cancer after failure of first line chemotherapy.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Topotecan cost around the world?
Topotecan is listed on 7 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Greece publishes a producer price (ex-factory); Iceland publishes a max wholesale. Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Greece | producer price (ex-factory) | 5 | 5 | EUR███.██ |
| Australia | ex-manufacturer | 2 | 4 | AUD███.██ |
| Romania | max producer price | 2 | 4 | RON███.██ |
| Italy | ex-factory (classe H) | 3 | 3 | EUR███.██ |
| Saudi Arabia | public | 2 | 3 | SAR███.██ |
| United Kingdom | hospital | 2 | 2 | GBP███.██ |
| Iceland | max wholesale | 1 | 2 | ISK███.██ |
| Italy | prezzo al pubblico (classe A) | 1 | 1 | EUR███.██ |
24 pack listings across 18 brand entries and 8 price bases, refreshed 08 Sep 2026. Ranges span every Topotecan pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Topotecan in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
8 holders have a Canadian DIN containing Topotecan, across 14 DINs, of which 4 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| TEVA CANADA LIMITED | 3 | 1 | TEVA-TOPOTECAN, TOPOTECAN INJECTION | Sourceable in Canada |
| ACCORD HEALTHCARE INC | 2 | 1 | TOPOTECAN HYDROCHLORIDE FOR INJECTION | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 2 | 1 | TOPOTECAN FOR INJECTION, TOPOTECAN INJECTION | Sourceable in Canada |
| PFIZER CANADA ULC | 1 | 1 | TOPOTECAN HYDROCHLORIDE FOR INJECTION | Sourceable in Canada |
| MYLAN PHARMACEUTICALS ULC | 2 | 0 | MYLAN-TOPOTECAN HYDROCHLORIDE FOR INJECTION, TOPOTECAN HYDROCHLORIDE FOR INJECTION | No marketed DIN |
| PHARMASCIENCE INC | 2 | 0 | PMS-TOPOTECAN | No marketed DIN |
| FRESENIUS KABI CANADA LTD | 1 | 0 | TOPOTECAN FOR INJECTION | No marketed DIN |
| NOVARTIS PHARMACEUTICALS CANADA INC | 1 | 0 | HYCAMTIN | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
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 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Available in 1 mg/vial and 4 mg/vial strengths. Single-use vials. |
| Storage | Store vials between 15°C and 30°C. Protect from light. Reconstituted solution stable for up to 24 hours under refrigeration. |
| 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, because this listing covers more than one of them.
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 | Topotecan |
|---|---|
| ATC code | L01CE01 |
| 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) | 02441071 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2441071 |
| Brand name | TEVA-TOPOTECAN |
| Generic / active ingredient | TOPOTECAN (TOPOTECAN HYDROCHLORIDE) : 4 MG |
| Market authorization holder | TEVA CANADA LIMITED |
| Health Canada schedule | Prescription |
| ATC code | L01CE01 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01CE |
| Current status | MARKETED |
| Status date | 09-Oct-2020 |
| Original market date | 2015-11-17 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
1.5 mg/m2 by IV infusion over 30 minutes daily for 5 consecutive days of a 21-day course. Minimum 4 courses recommended. Dose reductions required for hematologic toxicity or renal impairment.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to topotecan; pregnancy or breast-feeding; severe bone marrow depression (neutrophils < 1.5x10^9/L, platelets < 100x10^9/L); severe renal impairment (CrCl < 20 mL/min).
Warnings and precautions
Severe bone marrow suppression (primarily neutropenia) is dose-limiting. Risk of fatal neutropenic colitis, GI perforation, and interstitial lung disease. Monitor blood counts frequently.
Is Topotecan in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Resolved — reported by SANDOZ CANADA INCORPORATED, last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
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.
1 · Same molecule, other Canadian presentations
4 of 14 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| TOPOTECAN HYDROCHLORIDE FOR INJECTION | 1 MG | SOLUTION | PFIZER CANADA ULC | MARKETED | 02379422 |
| TOPOTECAN HYDROCHLORIDE FOR INJECTION | 1 MG | SOLUTION | ACCORD HEALTHCARE INC | MARKETED | 02396378 |
| TOPOTECAN INJECTION | 1 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02390981 |
| HYCAMTIN | 4 MG | POWDER FOR SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | CANCELLED POST MARKET | 02231116 |
| MYLAN-TOPOTECAN HYDROCHLORIDE FOR INJECTION | 4 MG | POWDER FOR SOLUTION | MYLAN PHARMACEUTICALS ULC | CANCELLED PRE MARKET | 02392798 |
| PMS-TOPOTECAN | 1 MG | POWDER FOR SOLUTION | PHARMASCIENCE INC | CANCELLED PRE MARKET | 02406438 |
| PMS-TOPOTECAN | 4 MG | POWDER FOR SOLUTION | PHARMASCIENCE INC | CANCELLED POST MARKET | 02406446 |
| TEVA-TOPOTECAN | 1 MG | POWDER FOR SOLUTION | TEVA CANADA LIMITED | APPROVED | 02441063 |
| TOPOTECAN FOR INJECTION | 4 MG | POWDER FOR SOLUTION | SANDOZ CANADA INCORPORATED | CANCELLED POST MARKET | 02333880 |
| TOPOTECAN FOR INJECTION | 4 MG | POWDER FOR SOLUTION | FRESENIUS KABI CANADA LTD | CANCELLED POST MARKET | 02346656 |
2 · Same class — other molecules in ATC L01CE
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Irinotecan | CAMPTOSAR · IRINOTECAN · IRINOTECAN FOR INJECTION · IRINOTECAN HYDROCHLORIDE INJECTION · +5 more | 18 | 8 | Yes |
| Topotecan | HYCAMTIN · MYLAN-TOPOTECAN HYDROCHLORIDE FOR INJECTION · PMS-TOPOTECAN · TEVA-TOPOTECAN · +3 more | 14 | 4 | 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 L01C
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01CD | Cabazitaxel · Docetaxel · Paclitaxel | 41 | 13 |
| L01CA | Vinblastine · Vincristine · Vindesine · Vinorelbine | 22 | 7 |
| L01CB | Etoposide · Teniposide | 14 | 3 |
| L01CX | Trabectedin | 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.
What else is TEVA-TOPOTECAN called?
The same molecule, Topotecan, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Hycamtin | Latin | Australia |
| Topotecan Accord | Latin | Australia |
| Topotecan Hexal | Latin | Iceland |
| TOPOTECAN HOSPIRA | Latin | Saudi Arabia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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.