Approval · Notice of Compliance 23250 · 2020
FYCOMPA: Notice of Compliance 23250
Issued February 25, 2020
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
- 23250
- Date
- February 25, 2020
- 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
- Expansion of partial-onset seizure indication to include patients 7 years of age and older
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
- PERAMPANEL 0.5 MG per ML