Zometa: Withdrawal of the application to change the marketing authorisation
On 15 November 2007, 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 prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors.
|Date of issue of market authorisation valid throughout the European Union (if applicable)||
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Novartis withdraws its application to extend the marketing authorisation for Zometa (PDF/25.26 KB)
First published: 20/11/2007
Last updated: 20/11/2007
Withdrawal letter : Zometa (PDF/304.2 KB)
First published: 15/11/2007
Last updated: 15/11/2007
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Zometa (PDF/38.49 KB)
First published: 17/01/2008
Last updated: 17/01/2008
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').