FYCOMPA 12.0 MG
PERAMPANEL : 12.0 MG · DIN 02404567 · EISAI LIMITED
Health Canada status: MARKETED
What is FYCOMPA?
FYCOMPA 12.0 MG contains PERAMPANEL : 12.0 MG. It is listed in the Health Canada Drug Product Database under DIN 02404567, held by EISAI LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 17-May-2013. 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 FYCOMPA used for?
Adjunctive therapy for partial-onset seizures (7+ years) and primary generalized tonic-clonic (PGTC) seizures (12+ years) not satisfactorily controlled with 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 | 02404567 |
|---|---|
| Brand name | FYCOMPA |
| Generic / active ingredient | PERAMPANEL : 12.0 MG |
| Manufacturer | EISAI LIMITED |
| Strength | 12.0 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N03AX22 PERAMPANEL |
| AHFS class | 68:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 17-May-2013 |
How is it administered?
Oral administration. Titrate dose carefully. If doses are missed, resume the following day. Gradual withdrawal is advised to minimize increased seizure frequency.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text; refers to 'STORAGE AND STABILITY' section.
How is it supplied?
Not explicitly detailed in provided text; refers to 'DOSAGE FORMS, COMPOSITION AND PACKAGING' section.
Contraindications
Hypersensitivity to FYCOMPA or to any ingredient in the formulation or component of the container.
Warnings and precautions
Serious psychiatric/behavioural reactions (aggression, hostility, homicidal ideation). Suicidal ideation. Dizziness, gait disturbance, and falls. DRESS/multiorgan hypersensitivity.
What can be used instead?
Other Canadian products sharing ATC code N03AX22 PERAMPANEL. 12 of 13 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 |
|---|---|---|---|---|---|
| FYCOMPA | 10.0 MG | TABLET | EISAI LIMITED | MARKETED | DIN 02404559 |
| FYCOMPA | 8.0 MG | TABLET | EISAI LIMITED | MARKETED | DIN 02404540 |
| FYCOMPA | Strength | Tablet | EISAI LIMITED 6925 Century Ave, Suite 701 Mississauga Ontario Canada L5N 7K2 | MARKETED | DIN 02404524 |
| FYCOMPA | Strength | Tablet | EISAI LIMITED 6925 Century Ave, Suite 701 Mississauga Ontario Canada L5N 7K2 | MARKETED | DIN 02404532 |
| FYCOMPA | Strength | Tablet | EISAI LIMITED 6925 Century Ave, Suite 701 Mississauga Ontario Canada L5N 7K2 | MARKETED | DIN 02404516 |
| TARO-PERAMPANEL | 10 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | DIN 02522675 |
| TARO-PERAMPANEL | 12 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | DIN 02522683 |
| TARO-PERAMPANEL | 2 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | DIN 02522632 |
| TARO-PERAMPANEL | 4 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | DIN 02522640 |
| TARO-PERAMPANEL | 6 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | DIN 02522659 |
Who else supplies PERAMPANEL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. PERAMPANEL appears in 114 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.