Dapagliflozin Viatris (dapagliflozin)
- Region
- 🇪🇺 EU
- Active substance
- dapagliflozin
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
- CHMP opinion
- Thu 26 Jan 2023
- EU approval
- Fri 24 Mar 2023
- Designations
- Generic
- Application
- EMEA/H/C/006006
- ATC
- A10BK01
- Official record
- www.ema.europa.eu
Indication
Type 2 diabetes mellitus Dapagliflozin Viatris 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 Dapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease Dapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.