FYCOMPA DIN 02404532
Health Canada record
| Active ingredient(s) | PERAMPANEL 6.0 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N03AX22 PERAMPANEL |
| Original market date | 19-Jun-2013 |
| Current status date | 19-Jun-2013 |
| 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 |
|---|---|---|---|---|---|
| 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 |
| 02404524 | FYCOMPA | EISAI LIMITED | Tablet | PERAMPANEL 4.0 MG | Marketed |
| 02522675 | TARO-PERAMPANEL | TARO PHARMACEUTICALS INC | Tablet | PERAMPANEL 10 MG | Marketed |
| 02522683 | TARO-PERAMPANEL | TARO PHARMACEUTICALS INC | Tablet | PERAMPANEL 12 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 |
| 02460106 | FYCOMPA | EISAI LIMITED | Suspension | PERAMPANEL 0.5 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 14269 | 2013-04-04 | New Drug Submission (NDS) |
International API supply for PERAMPANEL
10 active FDA Drug Master Files.
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