Arikayce: Withdrawal of the marketing authorisation application


On 8 June 2016, Insmed Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Arikayce intended for the treatment of Mycobacterium avium complex (MAC) lung disease.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Arikayce (amikacin) (PDF/75.14 KB)

    First published: 24/06/2016
    Last updated: 14/10/2016

  • Key facts

    Product number
    Active substance
    • Amikacin sulfate
    Date of withdrawal
    Company making the application
    Insmed Limited
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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