Qtrilmet

RSS

metformin hydrochloride / saxagliptin / dapagliflozin

Authorised
This medicine is authorised for use in the European Union.

Overview

Qtrilmet is a diabetes medicine that contains the active substances metformin, saxagliptin and dapagliflozin. It is used to treat type 2 diabetes in:

  • adults whose blood sugar is not controlled well enough with metformin combined with either saxagliptin or dapagliflozin (including those also taking a sulphonylurea, another type of diabetes medicine);
  • adults who are already taking metformin, saxagliptin and dapagliflozin.
This EPAR was last updated on 10/12/2019

Authorisation details

Product details
Name
Qtrilmet
Agency product number
EMEA/H/C/004910
Active substance
  • metformin hydrochloride
  • Saxagliptin
  • dapagliflozin
International non-proprietary name (INN) or common name
metformin hydrochloride / saxagliptin / dapagliflozin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Date of issue of marketing authorisation valid throughout the European Union
11/11/2019
Contact address

AstraZeneca AB
Sodertalje
SE-151 85 Sodertalje
Sweden

Product information

11/11/2019 Qtrilmet - EMEA/H/C/004910 -

Contents

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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus:

  • to improve glycaemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control.
  • when already being treated with metformin and saxagliptin and dapagliflozin.

Assessment history

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