Imagify: Withdrawal of the marketing authorisation application

perflubutane

Overview

On 24 July 2014, Acusphere Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Imagify (perflubutane) intended to be used for diagnosing coronary heart disease.

Key facts

Name
Imagify
Product number
EMEA/H/C/002347
International non-proprietary name (INN) or common name
  • perflubutane
Active substance
  • Perflubutane
Date of withdrawal
24/07/2014
Company making the application
Acusphere 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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

How useful was this page?

Add your rating