Approval · Notice of Compliance 22658 · 2019
BELSOMRA: Notice of Compliance 22658
Issued September 17, 2019
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
- 22658
- Date
- September 17, 2019
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- Remove the 5 mg strength from the product monograph
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BELSOMRA | Not yet assigned | — |
Medicinal ingredients
- SUVOREXANT 10 MG per TAB
- SUVOREXANT 15 MG per TAB
- SUVOREXANT 20 MG per TAB