Edistride

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dapagliflozin

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

Overview

This is a summary of the European public assessment report (EPAR) for Edistride. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Edistride.

For practical information about using Edistride, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 29/11/2018

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
8
Date of issue of marketing authorisation valid throughout the European Union
09/11/2015
Contact address
85 Sodertalje
SE-151
Sweden

Product information

12/11/2018 Edistride - EMEA/H/C/004161 - WS/1380

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Edistride is indicated in adults aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control as:

Monotherapy

When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.

Add-on combination therapy

In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Assessment history

Changes since initial authorisation of medicine

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