Approval · Notice of Compliance 35958 · 2025
NPLATE: Notice of Compliance 35958
Issued September 5, 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
- 35958
- Date
- September 5, 2025
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product Monograph Update
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NPLATE | Not yet assigned | — |
Medicinal ingredients
- ROMIPLOSTIM 625 MCG per VIAL
- ROMIPLOSTIM 375 MCG per VIAL