APO-DAPAGLIFLOZIN 10 MG
DAPAGLIFLOZIN : 10 MG · DIN 02527197 · APOTEX INC
Health Canada status: MARKETED
What is APO-DAPAGLIFLOZIN?
APO-DAPAGLIFLOZIN 10 MG contains DAPAGLIFLOZIN : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02527197, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 16-May-2023. 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-DAPAGLIFLOZIN used for?
Adjunct to diet/exercise for glycemic control in T2DM; reduce risk of hospitalization for heart failure in T2DM; treatment of heart failure (HFrEF/HFpEF); reduce risk of eGFR decline/ESKD in CKD.
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 | 02527197 |
|---|---|
| Brand name | APO-DAPAGLIFLOZIN |
| Generic / active ingredient | DAPAGLIFLOZIN : 10 MG |
| Manufacturer | APOTEX INC |
| Strength | 10 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A10BK01 DAPAGLIFLOZIN |
| AHFS class | 68:20.18 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 16-May-2023 |
| Original market date | 2023-05-16 00:00:00 |
How is it administered?
T2DM: Start 5 mg once daily, may increase to 10 mg. Heart Failure/CKD: 10 mg once daily. Assess renal function before and during treatment. Interrupt 3 days prior to major surgery.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly stated in provided text (standard reference to section 11 which is not fully detailed in snippet).
How is it supplied?
5 mg: Bottles of 100, blisters of 30. 10 mg: Bottles of 100 and 500, blisters of 30.
Contraindications
Hypersensitivity to drug or ingredients; patients on dialysis.
Warnings and precautions
Diabetic ketoacidosis (can be atypical); volume depletion/hypotension; necrotizing fasciitis of the perineum; acute kidney injury; genital mycotic infections; urinary tract infections.
What can be used instead?
Other Canadian products sharing ATC code A10BK01 DAPAGLIFLOZIN. 26 of 36 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 |
|---|---|---|---|---|---|
| ACCEL-DAPAGLIFLOZIN | 10 MG | TABLET | ACCEL PHARMA INC | MARKETED | DIN 02543192 |
| ACCEL-DAPAGLIFLOZIN | 5 MG | TABLET | ACCEL PHARMA INC | MARKETED | DIN 02543184 |
| AG-DAPAGLIFLOZIN | 10 MG | TABLET | ANGITA PHARMA INC. | MARKETED | DIN 02533057 |
| AG-DAPAGLIFLOZIN | 5 MG | TABLET | ANGITA PHARMA INC. | MARKETED | DIN 02533049 |
| APO-DAPAGLIFLOZIN | 5 MG | TABLET | APOTEX INC | MARKETED | DIN 02527189 |
| AURO-DAPAGLIFLOZIN | 10 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02531410 |
| AURO-DAPAGLIFLOZIN | 5 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02531402 |
| FORXIGA | 10 MG | TABLET | ASTRAZENECA CANADA INC | MARKETED | DIN 02435470 |
| FORXIGA | 5 MG | TABLET | ASTRAZENECA CANADA INC | MARKETED | DIN 02435462 |
| GLN-DAPAGLIFLOZIN | 10 MG | TABLET | GLENMARK PHARMACEUTICALS CANADA INC. | MARKETED | DIN 02519860 |
Who else supplies DAPAGLIFLOZIN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. DAPAGLIFLOZIN appears in 163 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.