Approval · Notice of Compliance 24650 · 2020
BIOTHRAX: Notice of Compliance 24650
Issued November 19, 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
- 24650
- Date
- November 19, 2020
- Company
- Emergent Biodefense Operations Lansing LlcLansing, Michigan, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: post-exposure prophylaxis of disease following suspected or confirmed bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BIOTHRAX | Not yet assigned | — |
Medicinal ingredients
- ANTHRAX ANTIGEN FILTRATE 50 MCG per 0.5ML