APO-ABIRATERONE FILM COATED TABLETS 500 MG
ABIRATERONE ACETATE : 500 MG · DIN 02491400 · APOTEX INC
Health Canada status: MARKETED
What is APO-ABIRATERONE FILM COATED TABLETS?
APO-ABIRATERONE FILM COATED TABLETS 500 MG contains ABIRATERONE ACETATE : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 02491400, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 25-Jan-2021. 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-ABIRATERONE FILM COATED TABLETS used for?
In combination with prednisone for metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed hormone-sensitive high-risk metastatic prostate cancer.
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 | 02491400 |
|---|---|
| Brand name | APO-ABIRATERONE FILM COATED TABLETS |
| Generic / active ingredient | ABIRATERONE ACETATE : 500 MG |
| Manufacturer | APOTEX INC |
| Strength | 500 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L02BX03 ABIRATERONE |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 25-Jan-2021 |
| Original market date | 2021-01-25 00:00:00 |
How is it administered?
1 g (two 500 mg or four 250 mg tablets) daily on an empty stomach. Take with 5-10 mg prednisone daily depending on indication. Swallow whole with water.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (section 11 mentioned but content not fully visible), though standard pharmaceutical storage is implied.
How is it supplied?
Bottles of 60 tablets; blisters of 14 and 60 tablets.
Contraindications
Hypersensitivity to the drug or ingredients; women who are or may potentially be pregnant.
Warnings and precautions
Mineralocorticoid excess (hypertension, hypokalemia, fluid retention); hepatotoxicity (including fatal cases); cardiovascular disease history caution; skeletal muscle effects (myopathy).
What can be used instead?
Other Canadian products sharing ATC code L02BX03 ABIRATERONE. 17 of 24 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-ABIRATERONE FILM COATED TABLETS | 250 MG | TABLET | APOTEX INC | MARKETED | DIN 02491397 |
| JAMP ABIRATERONE | 250 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02502305 |
| JAMP ABIRATERONE | 500 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02529629 |
| MAR-ABIRATERONE | 250 MG | TABLET | MARCAN PHARMACEUTICALS INC | MARKETED | DIN 02503980 |
| MAR-ABIRATERONE | 500 MG | TABLET | MARCAN PHARMACEUTICALS INC | MARKETED | DIN 02503999 |
| NAT-ABIRATERONE | 250 MG | TABLET | NATCO PHARMA (CANADA) INC | MARKETED | DIN 02494132 |
| PMS-ABIRATERONE | 250 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02492601 |
| PMS-ABIRATERONE | 500 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02501503 |
| PRZ-ABIRATERONE | 250 MG | TABLET | PHARMARIS CANADA INC | MARKETED | DIN 02540452 |
| PRZ-ABIRATERONE | 500 MG | TABLET | PHARMARIS CANADA INC | MARKETED | DIN 02540460 |
Who else supplies ABIRATERONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ABIRATERONE appears in 304 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.