Rituximab Mabion: Withdrawal of the marketing authorisation application



Mabion Spolka Akcyjna withdrew its duplicate applications for marketing authorisation of Rituximab Mabion for the treatment of certain blood cancers and inflammatory conditions.

The company withdrew the applications on 16 March 2020.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Rituximab Mabion (PDF/141.7 KB)

    First published: 30/03/2020
    Last updated: 24/06/2020

  • Key facts

    Rituximab Mabion
    Product number
    International non-proprietary name (INN) or common name
    • rituximab
    Active substance
    • rituximab
    Date of withdrawal
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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