Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - finerenone, quantity: 20 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; purified water; purified talc; titanium dioxide; iron oxide yellow - kerendia is indicated to delay progressive decline of kidney function and to reduce the risk of cardiovascular mortality and morbidity in adults with chronic kidney disease (with albuminuria) associated with type 2 diabetes, in addition to standard of care (see section 5.1 pharmacodynamic properties, clinical trials).

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - finerenone, quantity: 10 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; purified water; purified talc; titanium dioxide; iron oxide red - kerendia is indicated to delay progressive decline of kidney function and to reduce the risk of cardiovascular mortality and morbidity in adults with chronic kidney disease (with albuminuria) associated with type 2 diabetes, in addition to standard of care (see section 5.1 pharmacodynamic properties, clinical trials).

European Union - English - EMA (European Medicines Agency)

bayer ag - finerenone - renal insufficiency, chronic; diabetes mellitus, type 2 - agents acting on the renin-angiotensin system - kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

United States - English - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - finerenone (unii: de2o63yv8r) (finerenone - unii:de2o63yv8r) - kerendia is indicated to reduce the risk of sustained egfr decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (ckd) associated with type 2 diabetes (t2d). kerendia is contraindicated in patients: there are no available data on kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal studies have shown developmental toxicity at exposures about 4 times those expected in humans. (see data) . the clinical significance of these findings is unclear. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%,

Bangladesh - English - DGDA (Directorate General of Drug Administration)

navana pharmaceuticals ltd. - finerenone - tablet - 20 mg

Kenya - English - Pharmacy and Poisons Board

finerenone tablets 10 mg - tablet - finerenone ih 10 mg / tablet - finerenone

Canada - English - Health Canada

bayer inc - finerenone - tablet - 10mg - finerenone 10mg

Canada - English - Health Canada

bayer inc - finerenone - tablet - 20mg - finerenone 20mg

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

bayer east africa limited, kenya - finerenone - film coated tablet - 20 mg

Singapore - English - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - finerenone - tablet, film coated - finerenone 10mg