Approval · Notice of Compliance 37307 · 2026
OTEZLA: Notice of Compliance 37307
Issued April 10, 2026
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
- 37307
- Date
- April 10, 2026
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product Monograph reformatted to the Master Template. Update to the Product Monograph with new safety information
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OTEZLA | Not yet assigned | — |
Medicinal ingredients
- APREMILAST 10 MG per TAB
- APREMILAST 20 MG per TAB
- APREMILAST 30 MG per TAB