Approval · Notice of Compliance 36224 · 2025
ABRYSVO: Notice of Compliance 36224
Issued October 17, 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
- 36224
- Date
- October 17, 2025
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Abrysvo (Respiratory Syncytial Virus Stabilized Prefusion F Subunit Vaccine) is a bivalent vaccine indicated for: • Active immunization for the prevention of LRTD caused by RSV in individuals 18-59 years of age who are at increased risk for LRTD caused by RSV
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ABRYSVO | Not yet assigned | — |
Medicinal ingredients
- RSV SUBGROUP A STABILIZED PREFUSION F PROTEIN 60 MCG per VIAL
- RSV SUBGROUP B STABILIZED PREFUSION F PROTEIN 60 MCG per VIAL