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🇪🇺EU · EMAAuthorisedATC: A10BK01

Edistride(dapagliflozin propanediol monohydrate)

Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficiency, Chronic

Marketing Authorisation Holder: AstraZeneca AB

EMA Authorisation: 09/11/2015

INN: dapagliflozin

Indication

Type 2 diabetes mellitus Edistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Edistride is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Edistride is indicated in adults for the treatment of chronic kidney disease.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.