FYCOMPA DIN 02460106
Health Canada record
| Active ingredient(s) | PERAMPANEL 0.5 MG |
|---|---|
| Dosage form | Suspension |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N03AX22 PERAMPANEL |
| Original market date | |
| Current status date | 24-Feb-2023 |
| Source | Health Canada DPD |
Establishment licence of the holder
Eisai Limited — licence 101843, currently licensed, last inspection rating C (2023-03-29).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing PERAMPANEL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02404524 | FYCOMPA | EISAI LIMITED | Tablet | PERAMPANEL 4.0 MG | Marketed |
| 02404532 | FYCOMPA | EISAI LIMITED | Tablet | PERAMPANEL 6.0 MG | Marketed |
| 02404540 | FYCOMPA | EISAI LIMITED | Tablet | PERAMPANEL 8.0 MG | Marketed |
| 02404559 | FYCOMPA | EISAI LIMITED | Tablet | PERAMPANEL 10.0 MG | Marketed |
| 02404567 | FYCOMPA | EISAI LIMITED | Tablet | PERAMPANEL 12.0 MG | Marketed |
| 02404516 | FYCOMPA | EISAI LIMITED | Tablet | PERAMPANEL 2 MG | Marketed |
| 02522667 | TARO-PERAMPANEL | TARO PHARMACEUTICALS INC | Tablet | PERAMPANEL 8 MG | Marketed |
| 02522632 | TARO-PERAMPANEL | TARO PHARMACEUTICALS INC | Tablet | PERAMPANEL 2 MG | Marketed |
| 02522640 | TARO-PERAMPANEL | TARO PHARMACEUTICALS INC | Tablet | PERAMPANEL 4 MG | Marketed |
| 02522659 | TARO-PERAMPANEL | TARO PHARMACEUTICALS INC | Tablet | PERAMPANEL 6 MG | Marketed |
| 02522675 | TARO-PERAMPANEL | TARO PHARMACEUTICALS INC | Tablet | PERAMPANEL 10 MG | Marketed |
| 02522683 | TARO-PERAMPANEL | TARO PHARMACEUTICALS INC | Tablet | PERAMPANEL 12 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18795 | 2016-12-21 | Supplement to a New Drug Submission (SNDS) | ADDING AN ORAL SUSPENSION AS A NEW FORMULATION |
International API supply for PERAMPANEL
10 active FDA Drug Master Files.
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