Brilique: Withdrawal of the application to change the marketing authorisation



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.

  • 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

  • Key facts

    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • ticagrelor
    Active substance
    • Ticagrelor
    Date of withdrawal
    Company making the application
    AstraZeneca AB
    Withdrawal type

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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