This medicine is authorised for use in the European Union.


Forxiga is a medicine used to treat type 2 diabetes, chronic (long-term) heart failure and chronic kidney disease.

In type 2 diabetes, Forxiga 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), Forxiga is used in adults who have symptoms of the disease. Forxiga is also used in adults with chronic kidney disease.

Forxiga contains the active substance dapagliflozin.

This EPAR was last updated on 28/06/2023

Authorisation details

Product details
Agency product number
Active substance
dapagliflozin propanediol monohydrate
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
Publication details
Marketing-authorisation holder
AstraZeneca AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address
151 85 Sodertalje

Product information

30/05/2023 Forxiga - EMEA/H/C/002322 - IG1616

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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

Forxiga 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

Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure.

Chronic kidney disease

Forxiga is indicated in adults for the treatment of chronic kidney disease.

Assessment history

Changes since initial authorisation of medicine

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