Withdrawal of the marketing authorisation application
On 13 March 2008, Neurochem Luxco II SARL officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kiacta for the treatment of amyloid A amyloidosis. Kiacta was designated an orphan medicinal product on 31 July 2001.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Kiacta (PDF/364.71 KB)Adopted
First published: 16/06/2008
Last updated: 16/06/2008
Neurochem withdraws its marketing authorisation application for Kiacta (eprodisate disodium) (PDF/18.64 KB)
First published: 17/03/2008
Last updated: 17/03/2008
Withdrawal letter : Kiacta (PDF/45.72 KB)
First published: 13/03/2008
Last updated: 13/03/2008
Questions and answers on the withdrawal of the marketing application for Kiacta (PDF/33.78 KB)
First published: 08/04/2008
Last updated: 08/04/2008
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').