Approval · Notice of Compliance 17530 · 2015
FYCOMPA: Notice of Compliance 17530
Issued December 1, 2015
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
- 17530
- Date
- December 1, 2015
- 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 existing indication for adjunctive therapy to include management of primary generalized tonic-clonic (PGTC) seizures in adult patients (> greater than or equal to 18 years of age) with epilepsy.
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