Zektayos - Hepjuvo: Withdrawal of the marketing authorisation application

obeticholic acid

Overview

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
    EMA/747864/2021

  • Key facts

    Name
    Zektayos - Hepjuvo
    Product number
    EMEA/H/C/005249
    International non-proprietary name (INN) or common name
    • obeticholic acid
    Active substance
    • Obeticholic acid
    Date of withdrawal
    09/12/2021
    Company making the application
    Intercept Pharma International Ltd
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating