Qtern: Withdrawal of the application to change the marketing authorisation
saxagliptin /
dapagliflozin
Table of contents
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) |
15/07/2016 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
03/04/2018 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal letter: Qtern (PDF/125.52 KB)
First published: 27/04/2018
Last updated: 27/04/2018 -
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Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Qtern (saxagliptin / dapagliflozin) (PDF/78.76 KB)
First published: 27/04/2018
Last updated: 27/04/2018
EMA/251728/2018
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').