Voraxaze: Withdrawal of the marketing authorisation application

glucarpidase

Overview

On 21 May 2007, Protherics PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Voraxaze, for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.

  • List item

    Questions and answers on the withdrawal of the marketing application for Voraxaze (PDF/39.84 KB)


    First published: 02/06/2008
    Last updated: 02/06/2008
    EMEA/287136/2008

  • Key facts

    Name
    Voraxaze
    Product number
    EMEA/H/C/000681
    International non-proprietary name (INN) or common name
    • glucarpidase
    Active substance
    • glucarpidase
    Date of withdrawal
    21/05/2007
    Company making the application
    Protherics PLC
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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