Approval · Notice of Compliance 34715 · 2025
FORXIGA: Notice of Compliance 34715
Issued January 22, 2025
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
- 34715
- Date
- January 22, 2025
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph as per advisement letter. Update to Patient Medication Information. Update to package insert
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FORXIGA | Not yet assigned | — |
Medicinal ingredients
- DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE 5 MG per TAB
- DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE 10 MG per TAB