Approval · Notice of Compliance 20645 · 2018
FYCOMPA: Notice of Compliance 20645
Issued March 21, 2018
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
- 20645
- Date
- March 21, 2018
- 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 approved partial-onset seizure and primary generalized tonic-clonic seizure indications to include adolescent population (12-17 years of age)
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