Oncophage: Withdrawal of the marketing authorisation application

vitespen

Overview

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
    EMA/830607/2009

  • Key facts

    Name
    Oncophage
    Product number
    EMEA/H/C/001072
    International non-proprietary name (INN) or common name
    • vitespen
    Active substance
    • vitespen
    Date of withdrawal
    23/11/2009
    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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