Zometa: Withdrawal of the application to change the marketing authorisation
zoledronic acid
Table of contents
Overview
On 14 December 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zometa, in the treatment of early breast cancer in premenopausal women.
Key facts
Name |
Zometa |
Product number |
EMEA/H/C/000336 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
20/03/2001 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
14/12/2010 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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Withdrawal assessment report for Zometa (PDF/704.95 KB)
Adopted
First published: 08/03/2011
Last updated: 08/03/2011
EMA/CHMP/10929/2011 -
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Zometa: Withdrawal letter (PDF/675.81 KB)
First published: 25/01/2011
Last updated: 25/01/2011 -
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Novartis Europharm Ltd. withdraws its application for an extension of indication for Zometa (zoledronic acid) (PDF/48.09 KB)
First published: 15/12/2010
Last updated: 15/12/2010
EMA/818700/2010 -
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Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Zometa (zoledronic acid) (PDF/119.28 KB)
First published: 25/01/2011
Last updated: 25/01/2011
EMA/831243/2010 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').