Fanaptum: Withdrawal of the marketing authorisation application
iloperidone
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 |
|
Active substance |
|
Date of withdrawal |
13/03/2013 |
Company making the application | |
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').