Approval · Notice of Compliance 36593 · 2025
MAVIRET: Notice of Compliance 36593
Issued December 18, 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
- 36593
- Date
- December 18, 2025
- Company
- AbbVie CorporationSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Addition of new indication: treatment of acute hepatitis C virus (HCV) infection in adults and pediatric participants 3 years of age and older and weighing = 12 kg
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MAVIRET | Not yet assigned | — |
Medicinal ingredients
- GLECAPREVIR 100 MG per TAB
- PIBRENTASVIR 40 MG per TAB
- GLECAPREVIR 50 MG per SACHET
- PIBRENTASVIR 20 MG per SACHET