TEVA-DUTASTERIDE 0.5 MG
DUTASTERIDE : 0.5 MG · DIN 02408287 · TEVA CANADA LIMITED
Health Canada status: MARKETED
What is TEVA-DUTASTERIDE?
TEVA-DUTASTERIDE 0.5 MG contains DUTASTERIDE : 0.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02408287, held by TEVA CANADA LIMITED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 16-Jul-2014. 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-DUTASTERIDE used for?
Monotherapy: Treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men with enlarged prostates. Combination therapy (with tamsulosin): Treatment of moderate to severe symptomatic BPH.
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 | 02408287 |
|---|---|
| Brand name | TEVA-DUTASTERIDE |
| Generic / active ingredient | DUTASTERIDE : 0.5 MG |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 0.5 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | G04CB02 DUTASTERIDE |
| AHFS class | 92:04.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 16-Jul-2014 |
| Original market date | 2014-07-16 00:00:00 |
How is it administered?
0.5 mg once daily. Capsules should be swallowed whole and not chewed or opened, as contact with the contents may cause oropharyngeal mucosal irritation. May be taken with or without food.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (Table of Contents lists section 10, but text ends before details).
How is it supplied?
Not explicitly detailed in provided text (Summary mentions 0.5 mg Soft Gelatin Capsules).
Contraindications
Contraindicated in women, children, and patients with known hypersensitivity to dutasteride, other 5 alpha-reductase inhibitors, or any component of the preparation.
Warnings and precautions
May increase risk of high-grade prostate cancer. Reduces PSA levels by ~50%; double PSA values for comparison. 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 this molecule: Resolved — reported by SIVEM PHARMACEUTICALS ULC, 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?
Other Canadian products sharing ATC code G04CB02 DUTASTERIDE. 12 of 20 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 |
|---|---|---|---|---|---|
| AG-DUTASTERIDE | 0.5 MG | CAPSULE | ANGITA PHARMA INC. | MARKETED | DIN 02485672 |
| APO-DUTASTERIDE | 0.5 MG | CAPSULE | APOTEX INC | MARKETED | DIN 02404206 |
| AURO-DUTASTERIDE | 0.5 MG | CAPSULE | AURO PHARMA INC | MARKETED | DIN 02469308 |
| AVODART | 0.5 MG | CAPSULE | GLAXOSMITHKLINE INC | MARKETED | DIN 02247813 |
| DUTASTERIDE | 0.5 MG | CAPSULE | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02429012 |
| DUTASTERIDE | 0.5 MG | CAPSULE | SANIS HEALTH INC | MARKETED | DIN 02443058 |
| JAMP DUTASTERIDE CAPSULES | 0.5 MG | CAPSULE | JAMP PHARMA CORPORATION | MARKETED | DIN 02546167 |
| MINT-DUTASTERIDE | 0.5 MG | CAPSULE | MINT PHARMACEUTICALS INC | MARKETED | DIN 02428873 |
| NRA-DUTASTERIDE | 0.5 MG | CAPSULE | NORA PHARMA INC | MARKETED | DIN 02490587 |
| PRO-DUTASTERIDE | 0.5 MG | CAPSULE | PRO DOC LIMITEE | MARKETED | DIN 02543990 |
Who else supplies DUTASTERIDE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. DUTASTERIDE appears in 120 registered pack listings across 12 markets, published on 10 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.