Livmarli: Withdrawal of the marketing authorisation application



FGK Representative Service GmbH withdrew its application for a marketing authorisation of Livmarli for the treatment of progressive familial intrahepatic cholestasis type 2 (PFIC2) in patients 1 year of age and older.

The company withdrew the application on 23 August 2021.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Livmarli (maralixibat chloride) (PDF/129.66 KB)

    First published: 17/09/2021

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • maralixibat
    Active substance
    • Maralixibat chloride
    Date of withdrawal
    Company making the application
    FGK Representative Service GmbH
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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