Exkivity: Withdrawal of the marketing authorisation application



Takeda Pharma A/S withdrew its application for a conditional marketing authorisation of Exkivity (mobocertinib) for the treatment of a certain type of lung cancer.

The company withdrew the application on 20 July 2022.

  • List item

    Questions and answers on the withdrawal for the marketing authorisation of Exkivity (mobocertinib) (PDF/142.38 KB)

    First published: 19/08/2022
    Last updated: 24/11/2022

  • Key facts

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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