Zektayos - Hepjuvo: Withdrawal of the marketing authorisation application
obeticholic acid
Table of contents
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.
Key facts
Name |
Zektayos - Hepjuvo |
Product number |
EMEA/H/C/005249 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
09/12/2021 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Zektayos - Hepjuvo (PDF/13.45 MB)
Adopted
First published: 23/03/2022
EMA/CHMP/751783/2021 -
List item
Withdrawal letter: Zektayos-Hepjuvo (PDF/27.64 KB)
First published: 17/12/2021 -
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 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').