Approval · Notice of Compliance 23850 · 2020
FORXIGA: Notice of Compliance 23850
Issued June 30, 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
- 23850
- Date
- June 30, 2020
- Company
- Astrazeneca Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- To extend the indication of dapagliflozin to the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with or without diabetes, as an adjunct to standard of care therapy, in adults.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FORXIGA | Not yet assigned | — |
Medicinal ingredients
- DAPAGLIFLOZIN PROPANEDIOL 5 MG per TAB
- DAPAGLIFLOZIN PROPANEDIOL 10 MG per TAB