Sitoiganap: Withdrawal of the marketing authorisation application

autologous glioma tumor cell lysates (inactivated) / allogeneic glioma tumor cell lysates (inactivated) / allogeneic glioma tumor cells (inactivated) / autologous glioma tumor cells (inactivated)

Overview

Epitopoietic Research Corporation-Belgium (E.R.C.) withdrew its application for a marketing authorisation of Sitoiganap to treat adults with a type of brain cancer called malignant glioma, that is progressive (continues to grow) or recurrent (has come back) after treatment.

The company withdrew the application on 2 May 2022.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Sitoiganap (allogeneic and autologous haptenised and irradiated cells and cell lysates derived from glioma) (PDF/106.74 KB)


    First published: 20/05/2022
    EMA/266354/2022

  • Key facts

    Name
    Sitoiganap
    Product number
    EMEA/H/C/003693
    International non-proprietary name (INN) or common name
    • autologous glioma tumor cell lysates (inactivated)
    • allogeneic glioma tumor cell lysates (inactivated)
    • allogeneic glioma tumor cells (inactivated)
    • autologous glioma tumor cells (inactivated)
    Active substance
    • allogeneic glioma tumor cell lysates (inactivated)
    • allogeneic glioma tumor cells (inactivated)
    • autologous glioma tumor cell lysates (inactivated)
    • autologous glioma tumor cells (inactivated)
    Date of withdrawal
    02/05/2022
    Company making the application
    Epitopoietic Research Corporation-Belgium (E.R.C.)
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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