Forxiga is a medicine used to treat adults with diabetes, heart failure and chronic (long-term) kidney disease.
In diabetes, the medicine is used in adults whose condition is not controlled well enough.
• In type 2 diabetes, 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 type 1 diabetes, Forxiga is used with insulin in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.
In heart failure, Forxiga is used in adults who have symptoms of the disease and reduced ejection fraction (a measure of how well the heart pumps blood). Heart failure is the inability of the heart to pump enough blood around the body.
In chronic kidney disease, Forxiga is used in adults with reduced kidney function.
Forxiga contains the active substance dapagliflozin.
Forxiga : EPAR - Medicine overview (PDF/152.91 KB) (updated)
First published: 07/12/2012
Last updated: 02/09/2021
Forxiga : EPAR - Risk-management-plan summary (PDF/145.11 KB) (updated)
First published: 08/04/2019
Last updated: 02/09/2021
|Agency product number||
dapagliflozin propanediol monohydrate
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
151 85 Sodertalje
05/08/2021 Forxiga - EMEA/H/C/002322 - WS1941
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Drugs used in diabetes
Type 2 diabetes mellitus
Forxiga is indicated in adults 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.
Type 1 diabetes mellitus
Forxiga is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Chronic kidney disease
Forxiga is indicated in adults for the treatment of chronic kidney disease.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 202016/10/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019