Approval · Notice of Compliance 27985 · 2022
CRESEMBA: Notice of Compliance 27985
Issued April 13, 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
- 27985
- Date
- April 13, 2022
- Company
- Avir Pharma IncBlainville, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the Product Monograph (PM) with the non-clinical carcinogenicity data as per Advisement Letter dated September 24, 2021. In addition, the PM was updated with respect to the risk of hypersensitivity reaction and was converted to 2020 format.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CRESEMBA | Not yet assigned | — |
Medicinal ingredients
- ISAVUCONAZONIUM SULFATE 200 MG per VIAL
- ISAVUCONAZONIUM SULFATE 100 MG per CAP