Qtern

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saxagliptin / 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 Qtern. 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 Qtern.

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

This EPAR was last updated on 10/05/2019

Authorisation details

Product details
Name
Qtern
Agency product number
EMEA/H/C/004057
Active substance
  • Saxagliptin
  • dapagliflozin propanediol monohydrate
International non-proprietary name (INN) or common name
saxagliptin / dapagliflozin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD21
Publication details
Marketing-authorisation holder
Astra Zeneca AB
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
15/07/2016
Contact address
51 85 Södertälje
Sweden

Product information

01/03/2019 Qtern - EMEA/H/C/004057 - IG/1064

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

Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:

  • to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control,
  • when already being treated with the free combination of dapagliflozin and saxagliptin.

(See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)

Assessment history

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