Bosatria:

Withdrawal of the marketing authorisation application

mepolizumab

Overview

On 28 July 2009, Glaxo Group Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Bosatria, for the treatment of adults with hypereosinophilic syndrome to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) (PDF/33.78 KB)


    First published: 20/08/2009
    Last updated: 20/08/2009
    EMEA/505188/2009

  • Key facts

    Name
    Bosatria
    Product number
    EMEA/H/C/001069
    International non-proprietary name (INN) or common name
    • mepolizumab
    Active substance
    • Mepolizumab
    Date of withdrawal
    28/07/2009
    Company making the application
    Glaxo Group Limited
    Withdrawal type
    Initial authorisation

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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