Xegafri: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 3 May 2016, Clovis Oncology UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Xegafri, for the treatment of non-small cell lung cancer.
Key facts
Name |
Xegafri |
Product number |
EMEA/H/C/004053 |
Date of withdrawal |
05/05/2016 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Xegafri (PDF/1.43 MB)
First published: 22/06/2016
Last updated: 22/06/2016
EMA/CHMP/390341/2016 -
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Withdrawal letter : Xegafri (PDF/2.35 MB)
First published: 27/05/2016
Last updated: 27/05/2016 -
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Questions and answers on the withdrawal of the marketing authorisation application for Xegafri (rociletinib) (PDF/67.46 KB)
First published: 27/05/2016
Last updated: 27/05/2016
EMA/352428/2016 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').