Approval · Notice of Compliance 36544 · 2025
AMVUTTRA: Notice of Compliance 36544
Issued December 12, 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
- 36544
- Date
- December 12, 2025
- Company
- Alnylam Netherlands B.V.Amsterdam, Netherlands
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new indication: AMVUTTRA (vutrisiran injection) is indicated for the treatment of cardiomyopathy in adult patients with wild-type or hereditary transthyretin-mediated amyloidosis (wtATTR or hATTR amyloidosis).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AMVUTTRA | Not yet assigned | — |
Medicinal ingredients
- VUTRISIRAN SODIUM 25 MG per 0.5ML