Aranesp: Withdrawal of the application to change the marketing authorisation

darbepoetin alfa


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

  • Key facts

    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • darbepoetin alfa
    Active substance
    • darbepoetin alfa
    Date of withdrawal
    Company making the application
    Amgen Europe B.V.
    Withdrawal type

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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