saxagliptin / dapagliflozin

This medicine is authorised for use in the European Union.


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 07/05/2020

Authorisation details

Product details
Agency product number
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
Publication details
Marketing-authorisation holder
Astra Zeneca AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address
51 85 Södertälje

Product information

12/03/2020 Qtern - EMEA/H/C/004057 - WS/1743


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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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