Upkanz: Withdrawal of the marketing authorisation application
deferiprone
Table of contents
Overview
Apotex B.V. withdrew its application for a marketing authorisation of Upkanz for the treatment of pantothenate kinase-associated neurodegeneration.
The company withdrew the application on 10 August 2020.
Key facts
Name |
Upkanz |
Product number |
EMEA/H/C/005004 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
10/08/2020 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Upkanz (PDF/4.23 MB)
Adopted
First published: 28/10/2020
EMA/CHMP/532991/2020 -
List item
Withdrawal letter: Upkanz (PDF/65.94 KB)
First published: 18/09/2020 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Upkanz (deferiprone) (PDF/131.43 KB)
First published: 18/09/2020
EMA/463431/2020 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').