Edistride

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dapagliflozin

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

Overview

Edistride is a diabetes medicine used for 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, Edistride is used with insulin in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control the diabetes well enough.

Edistride contains the active substance dapagliflozin.

This EPAR was last updated on 21/11/2019

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
11
Date of issue of marketing authorisation valid throughout the European Union
09/11/2015
Contact address
85 Sodertalje
SE-151
Sweden

Product information

17/10/2019 Edistride - EMEA/H/C/004161 - WS/1637

Contents

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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Type 2 diabetes mellitus

Edistride 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

Edistride 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.

Assessment history

Changes since initial authorisation of medicine

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