Aranesp: Withdrawal of the application to change the marketing authorisation

darbepoetin alfa

Overview

On 21 February 2018, Amgen Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application to add treatment of anaemia in adult patients with myelodysplastic syndromes to the existing marketing authorisation.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Aranesp (darbepoetin alfa) (PDF/84.57 KB)


    First published: 23/03/2018
    Last updated: 23/03/2018
    EMA/165563/2018

  • Key facts

    Name
    Aranesp
    Product number
    EMEA/H/C/000332
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    08/06/2001
    International non-proprietary name (INN) or common name
    • darbepoetin alfa
    Active substance
    • darbepoetin alfa
    Date of withdrawal
    21/02/2018
    Company making the application
    Amgen Europe B.V.
    Withdrawal type
    Post-authorisation

    All documents

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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