Sutent: Withdrawal of the application to change the marketing authorisation
sunitinib
Table of contents
Overview
On 26 June 2018, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend use of Sutent to the treatment of patients at high risk of kidney cancer returning after surgery.
Key facts
Name |
Sutent |
Product number |
EMEA/H/C/000687 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
19/07/2006 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
26/06/2018 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal assessment report for Sutent (PDF/4.1 MB)
Adopted
First published: 17/08/2018
Last updated: 17/08/2018
EMA/CHMP/481973/2018 -
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Withdrawal letter: Sutent (PDF/144.11 KB)
First published: 27/07/2018
Last updated: 27/07/2018 -
List item
Questions and answers on the withdrawal of application for a change to the marketing authorisation for Sutent (sunitinib) (PDF/82.14 KB)
First published: 27/07/2018
Last updated: 27/07/2018
EMA/504631/2018 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').