Approval · Notice of Compliance 28581 · 2022
SPIKEVAX: Notice of Compliance 28581
Issued July 14, 2022
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
- 28581
- Date
- July 14, 2022
- Company
- Modernatx, Inc.
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of indication: Spikevax (elasomeran mRNA vaccine) is indicated for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 6 months of age and older.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SPIKEVAX | Not yet assigned | — |
Medicinal ingredients
- ELASOMERAN 0.1 MG per ML