Approval · Notice of Compliance 31495 · 2023
FLUCONAZOLE: Notice of Compliance 31495
Issued August 25, 2023
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
- 31495
- Date
- August 25, 2023
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Admin
- Reason
- Administrative: Labelling Update (to match Licensor)
- Canadian reference product
- DIFLUCAN (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUCONAZOLE | Not yet assigned | — |
Medicinal ingredients
- FLUCONAZOLE 50 MG per TAB
- FLUCONAZOLE 100 MG per TAB