Brilique: Withdrawal of the application to change the marketing authorisation

ticagrelor

Overview

AstraZeneca AB withdrew its application for the use of Brilique in the prevention of stroke in adults after a mild to moderate acute ischaemic stroke or high-risk transient ischaemic attack (TIA).

The company withdrew the application on 15 December 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
  • ticagrelor
Active substance
  • ticagrelor
Date of withdrawal
15/12/2021
Company making the application
AstraZeneca AB
Withdrawal type
Post-authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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