Xigduo

RSS

dapagliflozin / metformin

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

Overview

This is a summary of the European public assessment report (EPAR) for Xigduo. 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 Xigduo.

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

This EPAR was last updated on 16/10/2018

Authorisation details

Product details
Name
Xigduo
Agency product number
EMEA/H/C/002672
Active substance
  • metformin hydrochloride
  • dapagliflozin propanediol monohydrate
International non-proprietary name (INN) or common name
dapagliflozin / metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD15
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
15/01/2014
Contact address
SE-151-85 Sodertalje
Sweden

Product information

27/09/2018 Xigduo - EMEA/H/C/002672 - R/0044

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

Film coated tablet

Therapeutic indication

Xigduo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

  • in patients inadequately controlled on their maximally tolerated dose of metformin alone
  • in combination with other glucose lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products>/li>
  • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating