Approval · Notice of Compliance 27054 · 2021
COMIRNATY: Notice of Compliance 27054
Issued November 19, 2021
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
- 27054
- Date
- November 19, 2021
- Company
- Biontech Manufacturing GmbhMainz, Rheinland-Pfalz, Germany
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expansion of indication: COMIRNATY (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 5 years of age and older. /
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| COMIRNATY | 02522454 | Cancelled Post Market |
Medicinal ingredients
- TOZINAMERAN 10 MCG per 0.2ML