Plivensia: Withdrawal of the marketing authorisation application



On 26 October 2017, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Plivensia, for the treatment of rheumatoid arthritis.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Plivensia (sirukumab) (PDF/75.07 KB)

    First published: 10/11/2017
    Last updated: 05/02/2018

  • Key facts

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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