Xgeva: Withdrawal of the application to change the marketing authorisation
denosumab
Table of contents
Overview
On 13 January 2017, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Xgeva to be used to treat hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer).
Key facts
Name |
Xgeva |
Product number |
EMEA/H/C/002173 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
13/07/2011 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
13/01/2017 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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Withdrawal assessment report for Xgeva (PDF/1.01 MB)
Adopted
First published: 05/05/2017
Last updated: 05/05/2017
EMA/CHMP/52035/2017 -
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Withdrawal letter: Xgeva (PDF/63.74 KB)
First published: 27/01/2017
Last updated: 27/01/2017 -
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Questions and answers on the withdrawal of the marketing authorisation application for Xgeva (denosumab) (PDF/87.15 KB)
First published: 27/01/2017
Last updated: 27/01/2017
EMA/47097/2017 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').