Votrient: Withdrawal of the application to change the marketing authorisation
pazopanib
Table of contents
Overview
On 27 March 2014, GlaxoSmithKline Research & Development officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Votrient to include maintenance treatment in women with ovarian, fallopian tube or primary peritoneal cancer whose disease improved or remained stable after first-line chemotherapy.
Key facts
Name |
Votrient |
Product number |
EMEA/H/C/001141 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
14/06/2010 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
27/03/2014 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal letter: Votrient (PDF/13.49 KB)
First published: 25/04/2014
Last updated: 25/04/2014 -
List item
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Votrient (pazopanib) (PDF/80.14 KB)
First published: 25/04/2014
Last updated: 25/04/2014
EMA/232003/2014
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').