Qtern: Withdrawal of the application to change the marketing authorisation

saxagliptin / dapagliflozin

Overview

On 3 April 2018, AstraZeneca AB officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application to extend the approved use of Qtern in the treatment of type 2 diabetes.

Key facts

Name
Qtern
Product number
EMEA/H/C/004057
Date of issue of market authorisation valid throughout the European Union (if applicable)
14/07/2016
International non-proprietary name (INN) or common name
  • saxagliptin / dapagliflozin
Active substance
  • Saxagliptin
  • dapagliflozin propanediol monohydrate
Date of withdrawal
03/04/2018
Company making the application
Astra Zeneca AB
Withdrawal type
Post-authorisation

Related content

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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