Approval · Notice of Compliance 35387 · 2025
REPATHA: Notice of Compliance 35387
Issued May 16, 2025
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
- 35387
- Date
- May 16, 2025
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REPATHA | Not yet assigned | — |
Medicinal ingredients
- EVOLOCUMAB 140 MG per ML
- EVOLOCUMAB 120 MG per ML