Oportuzumab monatox DLRC Pharma Services: Withdrawal of the marketing authorisation application

oportuzumab monatox


DLRC Pharma Services withdrew its application for a marketing authorisation of Oportuzumab monatox DLRC Pharma Services for the treatment and prevention of recurrence of cancer of the bladder and the prevention of recurrence of papillary tumours.

The company withdrew the application on 20 August 2021.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Oportuzumab monatox DLRC Pharma Services (oportuzumab monatox) (PDF/126.71 KB)


    First published: 17/09/2021

  • Key facts

    Oportuzumab monatox DLRC Pharma Services
    Product number
    International non-proprietary name (INN) or common name
    • oportuzumab monatox
    Active substance
    • oportuzumab monatox
    Date of withdrawal
    Company making the application
    DLRC 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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