Puldysa: Withdrawal of the marketing authorisation application
idebenone
Table of contents
Overview
Santhera Pharmaceuticals (Deutschland) GmbH withdrew its application for a marketing authorisation of Puldysa for the treatment of Duchenne muscular dystrophy.
The company withdrew the application on 28 October 2020.
Key facts
Name |
Puldysa |
Product number |
EMEA/H/C/005123 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
28/10/2020 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Puldysa (PDF/8.87 MB)
Adopted
First published: 18/01/2021
EMA/CHMP/629264/2020 -
List item
Withdrawal letter: Puldysa (PDF/148.99 KB)
First published: 12/11/2020 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Puldysa (idebenone) (PDF/129.84 KB)
First published: 13/11/2020
EMA/594092/2020 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').