Imbarkyd: Withdrawal of the marketing authorisation application

bardoxolone methyl


Reata Ireland Limited withdrew its application for a marketing authorisation of Imbarkyd for the treatment of chronic kidney disease caused by Alport syndrome in adults and children 12 years and above.

The company withdrew the application on 9 November 2022.

  • List item

    Questions and answers on the withdrawal for the marketing authorisation of Imbarkyd (bardoxolone) (PDF/134.72 KB)

    First published: 16/12/2022
    Last updated: 07/02/2023

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • bardoxolone methyl
    Active substance
    • Bardoxolone methyl
    Date of withdrawal
    Company making the application
    Reata Ireland Limited
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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