Kiacta:

Withdrawal of the marketing authorisation application

eprodisate sodium

Overview

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.

  • List item

    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
    EMEA/136938/2008

  • Key facts

    Name
    Kiacta
    Product number
    EMEA/H/C/000779
    International non-proprietary name (INN) or common name
    • eprodisate sodium
    Active substance
    • eprodisate sodium
    Date of withdrawal
    13/03/2008
    Company making the application
    Neurochem Luxco II SARL
    Withdrawal type
    Initial authorisation

    All documents

    Related content

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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