Puldysa: Withdrawal of the marketing authorisation application

idebenone

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
  • idebenone
Active substance
  • idebenone
  • titanium dioxide
Date of withdrawal
28/10/2020
Company making the application
Santhera Pharmaceuticals (Deutschland) GmbH
Withdrawal type
Initial authorisation

Related content

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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