Folcepri: 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 Folcepri as a diagnostic medicine for selecting ovarian cancer patients to be treated with the cancer medicine Vynfinit (vintafolide).
Key facts
Name |
Folcepri |
Product number |
EMEA/H/C/002570 |
Active substance |
|
Date of withdrawal |
16/05/2014 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Folcepri (PDF/1.94 MB)
Adopted
First published: 14/08/2014
Last updated: 14/08/2014
EMA/CHMP/219148/2014 -
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Withdrawal letter: Folcepri (PDF/24.26 KB)
First published: 13/06/2014
Last updated: 13/06/2014 -
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Questions and answers on the withdrawal of the marketing authorisation application for Folcepri (etarfolatide) (PDF/75.11 KB)
First published: 13/06/2014
Last updated: 12/01/2015
EMA/303643/2014
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').