Dapagliflozin Viatris



This medicine is authorised for use in the European Union.


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.

Dapagliflozin Viatris contains the active substance dapagliflozin.

This EPAR was last updated on 04/04/2023

Authorisation details

Product details
Dapagliflozin Viatris
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Diabetes Mellitus, Type 2
  • Heart Failure, Systolic
  • Heart Failure
  • Renal Insufficiency, Chronic
Anatomical therapeutic chemical (ATC) code

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Viatris Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Damastown Industrial Park 
Dublin 15 

Product information

Dapagliflozin Viatris - EMEA/H/C/006006 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs used in diabetes

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.

Assessment history

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