Imbarkyd: Withdrawal of the marketing authorisation application
bardoxolone methyl
Table of contents
Overview
Reata Ireland Limited withdrew its application for a marketing authorisation of Imbarkyd for the treatment of chronic kidney disease caused by Alport syndrome in adults and children 12 years and above.
The company withdrew the application on 9 November 2022.
Key facts
Name |
Imbarkyd |
Product number |
EMEA/H/C/005869 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
09/11/2022 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Imbarkyd (PDF/6.27 MB)
Adopted
First published: 07/02/2023
EMA/913943/2022 -
List item
Withdrawal letter: Imbarkyd (PDF/45.83 KB)
First published: 16/12/2022 -
List item
Questions and answers on the withdrawal for the marketing authorisation of Imbarkyd (bardoxolone) (PDF/134.72 KB)
First published: 16/12/2022
Last updated: 07/02/2023
EMA/913652/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').