Puldysa: Withdrawal of the marketing authorisation application
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||
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|Company making the application|
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').