Garsun: Withdrawal of the marketing authorisation application



B & O Pharm withdrew its application for a marketing authorisation of Garsun, intended for the treatment of severe malaria caused by Plasmodium falciparum. 

The company withdrew the application on 8 December 2022.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Garsun (artesunate) (PDF/145.05 KB)

    First published: 01/03/2023

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • artesunate
    Active substance
    • artesunate
    Date of withdrawal
    Company making the application
    B And O Pharm
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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