Translarna: Withdrawal of the application to change the marketing authorisation

ataluren

Overview

On 6 March 2017, PTC Therapeutics International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Translarna to be used to treat cystic fibrosis.

Key facts

Name
Translarna
Product number
EMEA/H/C/002720
Date of issue of market authorisation valid throughout the European Union (if applicable)
31/07/2014
International non-proprietary name (INN) or common name
  • ataluren
Active substance
  • Ataluren
Date of withdrawal
06/03/2017
Company making the application
PTC Therapeutics International Limited
Withdrawal type
Post-authorisation

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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