<p>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.</p><p>For practical information about using Qtern, patients should read the package leaflet or contact their doctor or pharmacist.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:</p> <ul> <li>to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control,</li> <li>when already being treated with the free combination of dapagliflozin and saxagliptin.</li> </ul> <p>(See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)</p> </div>
Therapeutic Area (MeSH)
ATC Code
A10BD21
ATC Item
N/A
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| saxagliptin | N/A | saxagliptin |
| dapagliflozin propanediol monohydrate | N/A | dapagliflozin propanediol monohydrate |
EMA Name
Qtern
Medicine Name
Qtern
Aliases
N/ANo risk management plan link.
