Approval · Notice of Compliance 34071 · 2024
COMIRNATY: Notice of Compliance 34071
Issued September 24, 2024
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
- 34071
- Date
- September 24, 2024
- Company
- Biontech Manufacturing GmbhMainz, Rheinland-Pfalz, Germany
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to antigen composition (Omicron KP.2 variant). Addition of new pre-filled syringe presentation. Addition of new multidose vial presentation
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| COMIRNATY | Not yet assigned | — |
Medicinal ingredients
- *SARSCOV2 S-PROTEIN MRNA, 5'[M27,3'-OGPPP(M12'-O)APG], 3'POLYA+LINKER 30 MCG per DOSE
- BNT162B2 3 MCG per DOSE
- BNT162B2 10 MCG per DOSE