Entolimod TMC: Withdrawal of the marketing authorisation application

entolimod

Overview

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
    EMA/632431/2018

  • Key facts

    Name
    Entolimod TMC
    Product number
    EMEA/H/C/004656
    International non-proprietary name (INN) or common name
    • entolimod
    Active substance
    • Entolimod
    Date of withdrawal
    31/07/2018
    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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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