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.
Ethyl Eicosapent soft gelatin capsules
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Ethyl eicosapent soft gelatin capsules (PDF/226.38 KB)Adopted
First published: 03/03/2010
Last updated: 03/03/2010
Amarin Neuroscience Ltd withdraws its marketing authorisation application for Ethyl Eicosapent Soft Capsules (ethyl eicosapent) (PDF/47.34 KB)
First published: 08/12/2009
Last updated: 08/12/2009
Withdrawal letter : Ethyl Eicosapent (PDF/26.29 KB)
First published: 01/12/2009
Last updated: 01/12/2009
Questions and answers on the withdrawal of the marketing authorisation application for Ethyl Eicosapent soft gelatin capsules (ethyl eicosapent) (PDF/56.83 KB)
First published: 17/12/2009
Last updated: 17/12/2009
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').