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


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

Ethyl Eicosapent soft gelatin capsules
Product number
Date of withdrawal
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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