Approval · Notice of Compliance 24568 · 2020
IMVAMUNE: Notice of Compliance 24568
Issued November 5, 2020
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
- 24568
- Date
- November 5, 2020
- Company
- Bavarian Nordic AsHellerup, Denmark
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: active immunization against smallpox, monkeypox and related orthopoxivirus infection and disease in adult 18 years of age and older determined to be at risk for exposure. the vaccine may be used for both primary vaccination and revaccination
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IMVAMUNE | Not yet assigned | — |
Medicinal ingredients
- MODIFIED VACCINIA VIRUS (ANKARA-BAVARIAN NORDIC) 50,000,000 TCID50 per 0.5ML