Approval · Notice of Compliance 34383 · 2024
CRESEMBA: Notice of Compliance 34383
Issued November 15, 2024
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
- 34383
- Date
- November 15, 2024
- Company
- Avir Pharma IncBlainville, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new pediatric indication: CRESEMBA (isavuconazole, as isavuconazonium sulfate) is an azole antifungal indicated for use in adults and pediatrics from 1 year to up to 18 years for the treatment of invasive aspergillosis and invasive mucormycosis. Addition of new strength: 40 mg capsule
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CRESEMBA | Not yet assigned | — |
| CRESEMBA | 02553279 | Marketed |
Medicinal ingredients
- ISAVUCONAZONIUM SULFATE 100 MG per CAP
- ISAVUCONAZONIUM SULFATE 200 MG per VIAL
- ISAVUCONAZONIUM SULFATE 40 MG per CAP