Zavesca: Withdrawal of the application to change the marketing authorisation

miglustat

Overview

On 19 February 2008, Actelion Registration Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zavesca, in the treatment of neurological manifestations in patients with Niemann Pick type C disease.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Zavesca (PDF/42.09 KB)


    First published: 19/03/2008
    Last updated: 19/03/2008
    EMEA/121008/2008

  • Key facts

    Name
    Zavesca
    Product number
    EMEA/H/C/000435
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    20/11/2002
    International non-proprietary name (INN) or common name
    • miglustat
    Active substance
    • miglustat
    Date of withdrawal
    19/02/2008
    Company making the application
    Janssen Cilag International NV
    Withdrawal type
    Post-authorisation

    All documents

    Related content

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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