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KERENDIA DIN 02564726

Status: Approved
Holder: BAYER INC
Molecule: FINERENONE

Health Canada record

Active ingredient(s)FINERENONE 40 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCC03DA05 FINERENONE
Original market date
Current status date19-Jan-2026
SourceHealth Canada DPD

Establishment licence of the holder

Bayer Inc — licence 101029, currently licensed, last inspection rating C (2023-02-07).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing FINERENONE

DINProductCompanyFormStrengthStatus
02531917KERENDIABAYER INCTabletFINERENONE 10 MGMarketed
02531925KERENDIABAYER INCTabletFINERENONE 20 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
367512026-01-19Supplement to a New Drug Submission (SNDS)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.

International API supply for FINERENONE

23 active FDA Drug Master Files.

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