Translarna: Withdrawal of the application to change the marketing authorisation
ataluren
Table of contents
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 |
|
Active substance |
|
Date of withdrawal |
06/03/2017 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal letter: Translarna (PDF/39.85 KB)
First published: 24/03/2017
Last updated: 24/03/2017 -
List item
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Translarna (ataluren) (PDF/74.67 KB)
First published: 24/03/2017
Last updated: 24/03/2017
EMA/185561/2017
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 201918/10/2019
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29/09/2014
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10/07/2014
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23/05/2014
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23/05/2014
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21/02/2014
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 201424/01/2014