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 to improve blood sugar control. It can be used on its own 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 blood sugar well enough.

Edistride contains the active substance dapagliflozin. This medicine is the same as Forxiga, which is already authorised in the EU. The company that makes Forxiga has agreed that its scientific data can be used for Edistride (‘informed consent’).

This EPAR was last updated on 08/04/2019

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
Anatomical therapeutic chemical (ATC) code
A10BK01
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
09/11/2015
Contact address
85 Sodertalje
SE-151
Sweden

Product information

20/03/2019 Edistride - EMEA/H/C/004161 - WS/1344

Contents

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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

 Edistride is indicated in adults for the treatment of insufficiently controlled

  • type 2 diabetes mellitus as an adjunct to diet and exercise, to improve glycaemic control,
  • as monotherapy when metformin is considered inappropriate due to intolerance.
  • in addition to other medicinal products for the treatment of type 2 diabetes.
  • 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.

For clinical study results with respect to populations studied, effects on glycaemic control and combinations with other medicinal products see sections 4.4, 4.5 and 5.1.

Assessment history

Changes since initial authorisation of medicine

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