Approval · Notice of Compliance 36751 · 2026
KERENDIA: Notice of Compliance 36751
Issued January 19, 2026
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
- 36751
- Date
- January 19, 2026
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new indication: KERENDIA (finerenone) is indicated as an adjunct to standard of care in adults with heart failure with left ventricular ejection fraction (LVEF) =40% to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits. Addition of new strength: 40 mg. Update to package labels.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KERENDIA | Not yet assigned | — |
| KERENDIA | 02564726 | Approved |
Medicinal ingredients
- FINERENONE 10 MG per TAB
- FINERENONE 20 MG per TAB
- FINERENONE 40 MG per TAB