APO-ENTACAPONE 200 MG
ENTACAPONE : 200 MG · DIN 02321459 · APOTEX INC
Health Canada status: APPROVED
What is APO-ENTACAPONE?
APO-ENTACAPONE 200 MG contains ENTACAPONE : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02321459, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as approved, status dated 29-Mar-2012. 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-ENTACAPONE used for?
Adjunct to levodopa/carbidopa or levodopa/benserazide for idiopathic Parkinson’s Disease patients experiencing end-of-dose “wearing-off”.
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 | 02321459 |
|---|---|
| Brand name | APO-ENTACAPONE |
| Generic / active ingredient | ENTACAPONE : 200 MG |
| Manufacturer | APOTEX INC |
| Strength | 200 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N04BX02 ENTACAPONE |
| AHFS class | 28:36.12 |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 29-Mar-2012 |
How is it administered?
200 mg with each levodopa/DDC inhibitor dose. Max 10 times daily (2000 mg/day). Adjust levodopa dose if needed when starting. Do not stop abruptly.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text.
How is it supplied?
Not explicitly detailed in provided text (mentions 200 mg tablets).
Contraindications
Hypersensitivity; hepatic impairment; concomitant non-selective MAO inhibitors; pheochromocytoma; narrow angle glaucoma; history of NMS or rhabdomyolysis; undiagnosed skin lesions/melanoma.
Warnings and precautions
Sudden onset of sleep; increased risk of melanoma; prostate cancer risk; cardiovascular events (MI, ischemia); Neuroleptic Malignant Syndrome (NMS) upon withdrawal; rhabdomyolysis; colitis.
What can be used instead?
Other Canadian products sharing ATC code N04BX02 ENTACAPONE. 3 of 7 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 |
|---|---|---|---|---|---|
| MINT-ENTACAPONE | 200 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | DIN 02535939 |
| SANDOZ ENTACAPONE | 200 MG | TABLET | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02380005 |
| TEVA-ENTACAPONE | 200 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02375559 |
| AURO-ENTACAPONE | 200 MG | TABLET | AURO PHARMA INC | APPROVED | DIN 02431602 |
| COMTAN | 200 MG | TABLET | SANDOZ CANADA INCORPORATED | DORMANT | DIN 02243763 |
| MYLAN-ENTACAPONE | 200 MG | TABLET | MYLAN PHARMACEUTICALS ULC | CANCELLED POST MARKET | DIN 02390337 |
Who else supplies ENTACAPONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ENTACAPONE appears in 20 registered pack listings across 11 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.