Arikayce: Withdrawal of the marketing authorisation application

amikacin

Overview

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
    EMA/430267/2016

  • Key facts

    Name
    Arikayce
    Product number
    EMEA/H/C/003936
    International non-proprietary name (INN) or common name
    • amikacin
    Active substance
    • Amikacin sulfate
    Date of withdrawal
    08/06/2016
    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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