Entolimod TMC: Withdrawal of the marketing authorisation application


On 31 July 2018, TMC Pharma Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Entolimod TMC, intended to be used to reduce the risk of death following exposure to potentially lethal amounts of radiation.

  • List item

    Questions and answers on Entolimod TMC (PDF/75.01 KB)

    First published: 26/09/2018

  • Key facts

    Entolimod TMC
    Product number
    Active substance
    • Entolimod
    Date of withdrawal
    Company making the application
    TMC Pharma Services Ltd
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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