Puldysa: Withdrawal of the marketing authorisation application
Table of contents
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.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Puldysa (PDF/8.87 MB)Adopted
First published: 18/01/2021
Withdrawal letter: Puldysa (PDF/148.99 KB)
First published: 12/11/2020
Questions and answers on the withdrawal of application for the marketing authorisation of Puldysa (idebenone) (PDF/129.84 KB)
First published: 13/11/2020
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').