Forxiga

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dapagliflozin

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

Overview

Forxiga 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, Forxiga 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.

Forxiga contains the active substance dapagliflozin.

This EPAR was last updated on 08/04/2019

Authorisation details

Product details
Name
Forxiga
Agency product number
EMEA/H/C/002322
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
14
Date of issue of marketing authorisation valid throughout the European Union
11/11/2012
Contact address
151 85 Sodertalje
Sweden

Product information

20/03/2019 Forxiga - EMEA/H/C/002322 - WS/1344

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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 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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