Approval · Notice of Compliance 18795 · 2016
FYCOMPA: Notice of Compliance 18795
Issued December 21, 2016
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
- 18795
- Date
- December 21, 2016
- 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
- Adding an oral suspension as a new formulation
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FYCOMPA | 02460106 | Cancelled Pre Market |
Medicinal ingredients
- PERAMPANEL 0.5 MG per ML