Brilique: Withdrawal of the application to change the marketing authorisation
Table of contents
Overview
AstraZeneca AB withdrew its application for the use of Brilique with aspirin (acetylsalicylic acid) to prevent problems caused by blood clots in adults with coronary artery disease and type 2 diabetes who have not previously had a heart attack and who have had a procedure to unblock the blood vessels of the heart (percutaneous coronary intervention, PCI).
The company withdrew the application on 5 March 2021.
Key facts
Name |
Brilique |
Product number |
EMEA/H/C/001241 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
03/12/2010 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
05/03/2021 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
-
List item
Withdrawal assessment report for Brilique (PDF/2.71 MB)
Adopted
First published: 25/05/2021
EMA/459475/2019 -
List item
Withdrawal letter: Brilique (PDF/122.12 KB)
First published: 26/03/2021 -
List item
Questions and answers on the withdrawal of application to change the marketing authorisation for for Brilique (ticagrelor) (PDF/144.25 KB)
First published: 26/03/2021
Last updated: 25/05/2021
EMA/170569/2021 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').