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