Qutenza: Withdrawal of the application to change the marketing authorisation
capsaicin
Table of contents
Overview
On 14 March 2012, Astellas Pharma Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Qutenza, which would have extended its use to patients with diabetes who have peripheral neuropathic pain not caused by their diabetes.
Key facts
Name |
Qutenza |
Product number |
EMEA/H/C/000909 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
15/05/2009 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
14/03/2012 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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Withdrawal assessment report for Qutenza (PDF/727.79 KB)
Adopted
First published: 20/04/2012
Last updated: 20/04/2012
EMA/252892/2012 -
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Withdrawal letter: Qutenza (PDF/129.06 KB)
First published: 16/04/2012
Last updated: 16/04/2012 -
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Astellas Pharma Europe B.V. withdraws its application for an extension of the indication for Qutenza (capsaicin) (PDF/44.08 KB)
First published: 20/03/2012
Last updated: 20/03/2012
EMA/197157/2012 -
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Questions and answers on withdrawal of the application for a change to the marketing authorisation for Qutenza (capsaicin) (PDF/64.06 KB)
First published: 16/04/2012
Last updated: 16/04/2012
EMA/212297/2012 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').