Fanaptum:

Withdrawal of the marketing authorisation application

iloperidone

Table of contents

Overview

On 13 March 2013, Vanda Pharmaceuticals Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fanaptum for the treatment of schizophrenia.

Key facts

Name
Fanaptum
Product number
EMEA/H/C/002371
International non-proprietary name (INN) or common name
  • iloperidone
Active substance
  • iloperidone
Date of withdrawal
13/03/2013
Company making the application
Vanda Pharmaceuticals Ltd
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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