saxagliptin / dapagliflozin
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.
Qtern : EPAR - Summary for the public (PDF/85.16 KB)
First published: 27/07/2016
Last updated: 27/07/2016
Qtern : EPAR - Risk-management-plan summary (PDF/479.73 KB)
First published: 25/03/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
Astra Zeneca AB
|Date of issue of marketing authorisation valid throughout the European Union||
12/03/2020 Qtern - EMEA/H/C/004057 - WS/1743
- 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.
Drugs used in diabetes
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.)