Approval · Notice of Compliance 31040 · 2023
DAYVIGO: Notice of Compliance 31040
Issued June 22, 2023
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
- 31040
- Date
- June 22, 2023
- 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
- Update the Product Monograph (PM) based on 4 studies conducted to fulfill post-market requirements with the FDA; conversion to the 2020 master template.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DAYVIGO | Not yet assigned | — |
Medicinal ingredients
- LEMBOREXANT 10 MG per TAB
- LEMBOREXANT 5 MG per TAB