Oncophage: Withdrawal of the marketing authorisation application


On 23 November 2009, Antigenics Therapeutics Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Oncophage, intended as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Oncophage (vitespen) (PDF/100.64 KB)

    First published: 21/12/2009
    Last updated: 21/12/2009

  • Key facts

    Product number
    Date of withdrawal
    Company making the application
    Antigenics Therapeutics 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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