Ethyl Eicosapent soft gelatin capsules: Withdrawal of the marketing authorisation application

ethyl eicosapent

Overview

On 1 December 2009, Amarin Neuroscience Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ethyl Eicosapent soft gelatin capsules, for the long-term stabilisation of symptoms in patients with Huntington's disease.

Key facts

Name
Ethyl Eicosapent soft gelatin capsules
Product number
EMEA/H/C/001148
International non-proprietary name (INN) or common name
  • ethyl eicosapent
Active substance
  • ethyl eicosapent
Date of withdrawal
01/12/2009
Company making the application
Amarin Neuroscience 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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