Vynfinit: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 16 May 2014 Endocyte Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it has decided to withdraw its application for a marketing authorisation for Vynfinit, for the treatment of ovarian cancer which has become resistant to platinum-based cancer treatment.
Key facts
Name |
Vynfinit |
Product number |
EMEA/H/C/002571 |
Date of withdrawal |
16/05/2014 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Vynfinit (PDF/2.12 MB)
Adopted
First published: 14/08/2014
Last updated: 14/08/2014
EMA/CHMP/797690/2013 -
List item
Withdrawal letter: Vynfinit (PDF/23.07 KB)
First published: 16/06/2014
Last updated: 16/06/2014 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Vynfinit (vintafolide) (PDF/75.97 KB)
First published: 16/06/2014
Last updated: 12/01/2015
EMA/302516/2014
Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').