Puldysa: Withdrawal of the marketing authorisation application



Santhera Pharmaceuticals (Deutschland) GmbH withdrew its application for a marketing authorisation of Puldysa for the treatment of Duchenne muscular dystrophy.

The company withdrew the application on 28 October 2020.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Puldysa (idebenone) (PDF/129.84 KB)

    First published: 13/11/2020

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • idebenone
    Active substance
    • idebenone
    • titanium dioxide
    Date of withdrawal
    Company making the application
    Santhera Pharmaceuticals (Deutschland) GmbH
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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