Zektayos - Hepjuvo: Withdrawal of the marketing authorisation application

obeticholic acid


Intercept Pharma International Limited withdrew its application for a marketing authorisation of Zektayos-Hepjuvo for the treatment of non-alcoholic steatohepatitis with fibrosis (scarring), a form of liver inflammation unrelated to alcohol consumption.

The company withdrew the application on 9 December 2021.

  • List item

    Questions and answers on the withdrawal for the marketing authorisation of Zektayos-Hepjuvo (obeticholic acid) (PDF/133.4 KB)

    First published: 17/12/2021
    Last updated: 08/04/2022

  • Key facts

    Zektayos - Hepjuvo
    Product number
    International non-proprietary name (INN) or common name
    • obeticholic acid
    Active substance
    • Obeticholic acid
    Date of withdrawal
    Company making the application
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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