Approval · Notice of Compliance 12454 · 2011
BANZEL: Notice of Compliance 12454
Issued June 22, 2011
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
- 12454
- Date
- June 22, 2011
- Company
- Eisai LimitedWoodcliff Lake, New Jersey, United States
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Antiepileptic
Products in this notice
Medicinal ingredients
- RUFINAMIDE 100 MG per TAB
- RUFINAMIDE 200 MG per TAB
- RUFINAMIDE 400 MG per TAB