Approval · Notice of Compliance 35871 · 2025
SPIKEVAX: Notice of Compliance 35871
Issued August 21, 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
- 35871
- Date
- August 21, 2025
- Company
- Moderna Biopharma Canada CorporationToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to antigen composition (Omicron LP.8.1.variant)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SPIKEVAX | Not yet assigned | — |
Medicinal ingredients
- *SARSCOV2 S-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA 0.32 MG per ML
- *SARSCOV2 S-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA 50 MCG per 0.5ML