Votrient: Withdrawal of the application to change the marketing authorisation

pazopanib

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
  • pazopanib
Active substance
  • pazopanib
Date of withdrawal
27/03/2014
Company making the application
Novartis Europharm Limited 
Withdrawal type
Post-authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

How useful was this page?

Add your rating