ACT DUTASTERIDE 0.5 MG — DIN 02412691
DUTASTERIDE : 0.5 MG · TEVA CANADA LIMITED · CAPSULE · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is ACT DUTASTERIDE?
ACT DUTASTERIDE 0.5 MG contains DUTASTERIDE : 0.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02412691, held by TEVA CANADA LIMITED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 18-Apr-2019. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is ACT DUTASTERIDE used for?
Treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men with enlarged prostates, as monotherapy or in combination with tamsulosin. Not approved for prostate cancer prevention.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Dutasteride cost around the world?
Dutasteride is listed on 14 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; Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max). 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 |
|---|---|---|---|---|
| Australia | ex-manufacturer | 11 | 32 | AUD███.██ |
| Czechia | max producer price (ex-factory) | 22 | 29 | CZK███.██ |
| Italy | prezzo al pubblico (classe A) | 13 | 25 | EUR███.██ |
| Belgium | public | 14 | 14 | EUR███.██ |
| Luxembourg | reimbursement | 9 | 9 | EUR███.██ |
| United States | acquisition | 1 | 7 | USD███.██ |
| South Africa | single exit price | 7 | 7 | ZAR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 6 | 6 | EUR███.██ |
| Saudi Arabia | public | 5 | 6 | SAR███.██ |
| United Arab Emirates | public | 5 | 5 | AED███.██ |
| Bahrain | retail (max) | 5 | 5 | BHD███.██ |
| Greece | producer price (ex-factory) | 5 | 5 | EUR███.██ |
| Morocco | PPV (public price) | 1 | 4 | MAD███.██ |
| United Kingdom | hospital | 1 | 1 | GBP███.██ |
155 pack listings across 105 brand entries and 12 price bases, refreshed 08 Sep 2026. Ranges span every Dutasteride pack in that market, so a high figure is usually a larger pack rather than the same product.
This table is a regulatory record of where the molecule is listed. The DIN on this page is no longer authorized for sale in Canada, so Nexara does not quote it — see the alternatives above.
Is there a generic Dutasteride 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.
16 holders have a Canadian DIN containing Dutasteride, across 20 DINs, of which 12 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 |
|---|---|---|---|---|
| JAMP PHARMA CORPORATION | 2 | 1 | JAMP DUTASTERIDE, JAMP DUTASTERIDE CAPSULES | Sourceable in Canada |
| PRO DOC LIMITEE | 2 | 1 | DUTASTERIDE, PRO-DUTASTERIDE | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 2 | 1 | SANDOZ DUTASTERIDE | Sourceable in Canada |
| TEVA CANADA LIMITED | 2 | 1 | ACT DUTASTERIDE, TEVA-DUTASTERIDE | Sourceable in Canada |
| ANGITA PHARMA INC. | 1 | 1 | AG-DUTASTERIDE | Sourceable in Canada |
| APOTEX INC | 1 | 1 | APO-DUTASTERIDE | Sourceable in Canada |
| AURO PHARMA INC | 1 | 1 | AURO-DUTASTERIDE | Sourceable in Canada |
| GLAXOSMITHKLINE INC | 1 | 1 | AVODART | Sourceable in Canada |
| MINT PHARMACEUTICALS INC | 1 | 1 | MINT-DUTASTERIDE | Sourceable in Canada |
| NORA PHARMA INC | 1 | 1 | NRA-DUTASTERIDE | Sourceable in Canada |
| SANIS HEALTH INC | 1 | 1 | DUTASTERIDE | Sourceable in Canada |
| SIVEM PHARMACEUTICALS ULC | 1 | 1 | DUTASTERIDE | Sourceable in Canada |
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 | 0.5 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in provided text (mentions bottles/blisters in full monographs, but specific counts not in this snippet). |
| Storage | Not specified in the provided text snippet (refer to full monograph). |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Dutasteride |
|---|---|
| ATC code | G04CB02 |
| AHFS class | 92:04.00 |
| 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) | 02412691 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2412691 |
| Brand name | ACT DUTASTERIDE |
| Generic / active ingredient | DUTASTERIDE : 0.5 MG |
| Market authorization holder | TEVA CANADA LIMITED |
| Health Canada schedule | Prescription |
| ATC code | G04CB02 |
| ATC anatomical main group | G — Genito-urinary system and sex hormones |
| ATC therapeutic subgroup | G04CB |
| Current status | CANCELLED POST MARKET |
| Status date | 18-Apr-2019 |
| Original market date | 2014-09-05 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
0.5 mg once daily. Capsules should be swallowed whole and not chewed or opened. May be taken with or without food.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Contraindicated for use in women and children. Known hypersensitivity to dutasteride, other 5 alpha-reductase inhibitors, or any component of the preparation.
Warnings and precautions
Increased risk of high-grade prostate cancer. Women who are pregnant should not handle capsules. Monitor for cardiac failure when used with alpha-blockers. Do not donate blood for 6 months.
Is Dutasteride in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Resolved — reported by SIVEM PHARMACEUTICALS ULC, last seen 09 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
12 of 20 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| AG-DUTASTERIDE | 0.5 MG | CAPSULE | ANGITA PHARMA INC. | MARKETED | 02485672 |
| APO-DUTASTERIDE | 0.5 MG | CAPSULE | APOTEX INC | MARKETED | 02404206 |
| AURO-DUTASTERIDE | 0.5 MG | CAPSULE | AURO PHARMA INC | MARKETED | 02469308 |
| AVODART | 0.5 MG | CAPSULE | GLAXOSMITHKLINE INC | MARKETED | 02247813 |
| DUTASTERIDE | 0.5 MG | CAPSULE | SIVEM PHARMACEUTICALS ULC | MARKETED | 02429012 |
| DUTASTERIDE | 0.5 MG | CAPSULE | SANIS HEALTH INC | MARKETED | 02443058 |
| JAMP DUTASTERIDE CAPSULES | 0.5 MG | CAPSULE | JAMP PHARMA CORPORATION | MARKETED | 02546167 |
| MINT-DUTASTERIDE | 0.5 MG | CAPSULE | MINT PHARMACEUTICALS INC | MARKETED | 02428873 |
| NRA-DUTASTERIDE | 0.5 MG | CAPSULE | NORA PHARMA INC | MARKETED | 02490587 |
| PRO-DUTASTERIDE | 0.5 MG | CAPSULE | PRO DOC LIMITEE | MARKETED | 02543990 |
2 · Same class — other molecules in ATC G04CB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Finasteride | ACCEL-FINASTERIDE TABLETS USP · ACH-FINASTERIDE · ACT FINASTERIDE · AG-FINASTERIDE · +19 more | 25 | 12 | Yes |
| Dutasteride | ACT DUTASTERIDE · AG-DUTASTERIDE · APO-DUTASTERIDE · AURO-DUTASTERIDE · +13 more | 20 | 12 | 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 G04C
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| G04CA | Alfuzosin · Silodosin · Tamsulosin · Tamsulosin And Dutasteride · Terazosin | 97 | 32 |
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 ACT DUTASTERIDE called?
The same molecule, Dutasteride, 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 |
|---|---|---|
| Avodart | Latin | Australia, Bahrain, Czechia, Morocco, South Africa |
| APO-Dutasteride | Latin | Australia |
| Duodart | Latin | Bahrain, Czechia, South Africa |
| ADADUT | Latin | Czechia |
| ATUCARE | Latin | Czechia |
| Doubluts | Latin | Australia |
| DUODART Capsule | Latin | Saudi Arabia |
| Dutacor | Latin | Australia |
| DUTALAN | Latin | Czechia |
| DUTASTERID ARISTO | Latin | Czechia |
| DUTASTERIDE OLPHA | Latin | Czechia |
| DUTASTERIDE-TAMSULOSIN ZPL | Latin | Australia |
| DUTASTERIDE/TAMSULOSIN-WGR | Latin | Australia |
| TADUSTIX | Latin | Czechia |
| ADATAM | Latin | Czechia |
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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.