Approval · Notice of Compliance 19191 · 2017
BANZEL: Notice of Compliance 19191
Issued April 20, 2017
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
- 19191
- Date
- April 20, 2017
- 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
- Add data from a clinical trial in children 1 to <4 years of age with lennox-gastaut syndrome in the pharmacology section of the product monograph
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BANZEL | Not yet assigned | — |
Medicinal ingredients
- RUFINAMIDE 40 MG per ML
- RUFINAMIDE 100 MG per TAB
- RUFINAMIDE 200 MG per TAB
- RUFINAMIDE 400 MG per TAB