Edistride is a medicine used to treat type 2 diabetes, heart failure and chronic (long-term) kidney disease.
In type 2 diabetes Edistride 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 heart failure, Edistride 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, Edistride is used in adults with reduced kidney function.
Edistride contains the active substance dapagliflozin.
Edistride : EPAR - Medicine overview (PDF/128.1 KB)
First published: 10/12/2015
Last updated: 20/01/2022
Edistride : EPAR - Risk-management-plan summary (PDF/145.12 KB)
First published: 10/12/2015
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||
23/06/2022 Edistride - EMEA/H/C/004161 - WS/2284
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Drugs used in diabetes
Type 2 diabetes mellitus
Edistride 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.
Edistride is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Chronic kidney disease
Edistride is indicated in adults for the treatment of chronic kidney disease.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 201525/09/2015