BANZEL DIN 02369648
Health Canada record
| Active ingredient(s) | RUFINAMIDE 400 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N03AF03 RUFINAMIDE |
| Original market date | 01-Sep-2011 |
| Current status date | 01-Sep-2011 |
| 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 RUFINAMIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02545985 | AURO-RUFINAMIDE | AURO PHARMA INC | Tablet | RUFINAMIDE 200 MG | Marketed |
| 02545993 | AURO-RUFINAMIDE | AURO PHARMA INC | Tablet | RUFINAMIDE 400 MG | Marketed |
| 02369613 | BANZEL | EISAI LIMITED | Tablet | RUFINAMIDE 100 MG | Marketed |
| 02369621 | BANZEL | EISAI LIMITED | Tablet | RUFINAMIDE 200 MG | Marketed |
| 02388685 | BANZEL | EISAI LIMITED | Suspension | RUFINAMIDE 40 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 12454 | 2011-06-22 | New Drug Submission (NDS) |
International API supply for RUFINAMIDE
8 active FDA Drug Master Files.
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