Forxiga is a medicine used in adults for treating:
- diabetes in patients 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.
- heart failure in patients who have symptoms of the disease and reduced ejection fraction (the proportion of blood leaving the heart). Heart failure is the inability of the heart to pump enough blood around the body.
Forxiga contains the active substance dapagliflozin.
Forxiga : EPAR - Medicine overview (PDF/148.74 KB) (updated)
First published: 07/12/2012
Last updated: 26/11/2020
Forxiga : EPAR - Risk-management-plan summary (PDF/154.15 KB) (updated)
First published: 08/04/2019
Last updated: 26/11/2020
|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||
03/11/2020 Forxiga - EMEA/H/C/002322 - WS/1737
- 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 and
cardiovascular 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
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