Imagify: Withdrawal of the marketing authorisation application


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

Product number
Active substance
  • Perflubutane
Date of withdrawal
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.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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