Basic Information
Dapagliflozin Viatris
Regulatory Information
EMEA/H/C/006006
March 24, 2023
January 26, 2023
4
November 21, 2024
Company Information
Ireland
Damastown Industrial Park Dublin 15
VIATRIS PHARMA LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
Dapagliflozin Viatris is a medicine used to treat type 2 diabetes, chronic (long-term) heart failure and chronic kidney disease. In type 2 diabetes, Dapagliflozin Viatris is used in adults and children from 10 years of age whose condition is not controlled well enough. It is used with appropriate diet and exercise in patients who cannot take metformin (another diabetes medicine). It can also be used as ‘add-on’ treatment to other diabetes medicines. In chronic heart failure (inability of the heart to pump enough blood around the body), Dapagliflozin Viatris is used in adults who have symptoms of the disease and reduced ejection fraction (a measure of how well the heart pumps blood). Dapagliflozin Viatris is also used in adults with chronic kidney disease. Dapagliflozin Viatris is a ‘generic medicine’. This means that Dapagliflozin Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Forxiga. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf). Dapagliflozin Viatris contains the active substance dapagliflozin.