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/447.65 KB)
First published: 25/03/2020
Last updated: 09/06/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Astra Zeneca AB
|Date of issue of marketing authorisation valid throughout the European Union||
51 85 Södertälje
30/05/2023 Qtern - EMEA/H/C/004057 - IG1616
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.)