APO-ESLICARBAZEPINE 800 MG
ESLICARBAZEPINE ACETATE : 800 MG · DIN 02537974 · APOTEX INC
Health Canada status: MARKETED
What is APO-ESLICARBAZEPINE?
APO-ESLICARBAZEPINE 800 MG contains ESLICARBAZEPINE ACETATE : 800 MG. It is listed in the Health Canada Drug Product Database under DIN 02537974, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 06-May-2025. 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-ESLICARBAZEPINE used for?
Monotherapy for partial-onset seizures in adults with epilepsy. Adjunctive therapy for partial-onset seizures in adults and children above 6 years of age not controlled by conventional therapy.
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 | 02537974 |
|---|---|
| Brand name | APO-ESLICARBAZEPINE |
| Generic / active ingredient | ESLICARBAZEPINE ACETATE : 800 MG |
| Manufacturer | APOTEX INC |
| Strength | 800 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N03AF04 ESLICARBAZEPINE |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 06-May-2025 |
How is it administered?
Monotherapy: Start 400 mg once daily, increase to 800 mg after 1 week. Adjunctive: Start 400 mg once daily, increase to 800 mg after 1 week. Max dose 1200 mg once daily. Swallow tablets whole.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 15°C to 30°C.
How is it supplied?
Available in 200 mg, 400 mg, 600 mg, and 800 mg strengths. (Specific container details like bottle counts not provided in the snippet).
Contraindications
Hypersensitivity to eslicarbazepine acetate or other carboxamide derivatives (e.g., carbamazepine, oxcarbazepine); history of, or presence of, second- or third-degree atrioventricular (AV) block.
Warnings and precautions
Suicidal ideation/behaviour; serious dermatologic reactions (SJS/TEN); drug-induced liver injury; hyponatremia; PR interval prolongation; dizziness/ataxia; somnolence; and cognitive dysfunction.
What can be used instead?
Other Canadian products sharing ATC code N03AF04 ESLICARBAZEPINE. 8 of 12 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-ESLICARBAZEPINE | 200 MG | TABLET | APOTEX INC | MARKETED | DIN 02537931 |
| APO-ESLICARBAZEPINE | 400 MG | TABLET | APOTEX INC | MARKETED | DIN 02537958 |
| APO-ESLICARBAZEPINE | 600 MG | TABLET | APOTEX INC | MARKETED | DIN 02537966 |
| AURO-ESLICARBAZEPINE | 200 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02527421 |
| AURO-ESLICARBAZEPINE | 400 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02527448 |
| AURO-ESLICARBAZEPINE | 600 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02527456 |
| AURO-ESLICARBAZEPINE | 800 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02527464 |
| APTIOM | 200 MG | TABLET | SUMITOMO PHARMA CANADA, INC. | CANCELLED POST MARKET | DIN 02426862 |
| APTIOM | 400 MG | TABLET | SUMITOMO PHARMA CANADA, INC. | CANCELLED POST MARKET | DIN 02426870 |
| APTIOM | 600 MG | TABLET | SUMITOMO PHARMA CANADA, INC. | CANCELLED POST MARKET | DIN 02426889 |
Who else supplies ESLICARBAZEPINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ESLICARBAZEPINE appears in 8 registered pack listings across 5 markets, published on 4 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.