Qtrilmet

Withdrawn

This medicine's authorisation has been withdrawn

metformin hydrochloride / saxagliptin / dapagliflozin

Overview

On 14 August 2020, the European Commission withdrew the marketing authorisation for Qtrilmet (metformin hydrochloride / saxagliptin / dapagliflozin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.

Qtrilmet was granted marketing authorisation in the EU on 11 November 2019 for the following indications 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. 

The marketing authorisation was initially valid for a 5-year period. The product had not yet been marketed in the EU. 

The European Public Assessment Report (EPAR) for Qtrilmet is updated to indicate that the marketing authorisation is no longer valid.

Qtrilmet : EPAR - Medicine overview

Reference Number: EMA/521799/2019

Qtrilmet : EPAR - Risk-management-plan summary

Product information

Qtrilmet : EPAR - Product information

Qtrilmet : EPAR - All authorised presentations

Product details

• Name of medicine:
  Qtrilmet
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004910
• Marketing authorisation holder:
  AstraZeneca AB

  SE-151 85 Sodertalje; Sweden

• Opinion adopted:
  19/09/2019
• Marketing authorisation issued:
  11/11/2019
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Qtrilmet : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Qtrilmet : EPAR - Public assessment report

Adopted Reference Number: EMA/524327/2019

CHMP summary of positive opinion for Qtrilmet

Adopted Reference Number: EMA/CHMP/478963/2019