Enpaxiq: Withdrawal of the marketing authorisation application

pacritinib

Overview

On 20 February 2017, CTI BioPharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Enpaxiq, for treating patients with an enlarged spleen or other symptoms of myelofibrosis.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Enpaxiq (pacritinib) (PDF/69.02 KB)


    First published: 24/03/2017
    Last updated: 24/03/2017
    EMA/192276/2017

  • Key facts

    Name
    Enpaxiq
    Product number
    EMEA/H/C/004193
    International non-proprietary name (INN) or common name
    • pacritinib
    Active substance
    • pacritinib citrate
    Date of withdrawal
    20/02/2017
    Company making the application
    CTI Life Sciences 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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