Approval · Notice of Compliance 32109 · 2023
FYCOMPA: Notice of Compliance 32109
Issued November 16, 2023
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 32109
- Date
- November 16, 2023
- Company
- Eisai LimitedWoodcliff Lake, New Jersey, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Removal of 0.5 mg/mL Oral Suspension dosage form (Cancelled pre-market) and Conversion to the 2020 Master Template.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FYCOMPA | Not yet assigned | — |
Medicinal ingredients
- PERAMPANEL 2 MG per TAB
- PERAMPANEL 4 MG per TAB
- PERAMPANEL 6 MG per TAB
- PERAMPANEL 8 MG per TAB
- PERAMPANEL 10 MG per TAB
- PERAMPANEL 12 MG per TAB