Aliqopa: Withdrawal of the marketing authorisation application

copanlisib

Overview

Bayer AG withdrew its application for a marketing authorisation of Aliqopa for the treatment of adult patients with previously treated marginal zone lymphoma (MZL), a cancer of a type of white blood cells called B lymphocytes or B cells.

The company withdrew the application on 20 December 2021.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Aliqopa (copanlisib) (PDF/114.84 KB)


    First published: 28/01/2022
    EMA/38839/2022

  • Key facts

    Name
    Aliqopa
    Product number
    EMEA/H/C/004334
    International non-proprietary name (INN) or common name
    • copanlisib
    Active substance
    • Copanlisib dihydrochloride
    Date of withdrawal
    20/12/2021
    Company making the application
    Bayer AG
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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