Edistride

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dapagliflozin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 04/04/2022

Authorisation details

Product details
Name
Edistride
Agency product number
EMEA/H/C/004161
Active substance
dapagliflozin propanediol monohydrate
International non-proprietary name (INN) or common name
dapagliflozin
Therapeutic area (MeSH)
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
Anatomical therapeutic chemical (ATC) code
A10BK01
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
09/11/2015
Contact address
85 Sodertalje
SE-151
Sweden

Product information

01/04/2022 Edistride - EMEA/H/C/004161 - IG1498/G

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
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.

Heart failure
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.

 

Assessment history

Changes since initial authorisation of medicine

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