Folcepri: Withdrawal of the marketing authorisation application

etarfolatide

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
International non-proprietary name (INN) or common name
  • etarfolatide
Active substance
  • Etarfolatide
Date of withdrawal
16/05/2014
Company making the application
Endocyte Europe, B.V.
Withdrawal type
Initial authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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