Xgeva: Withdrawal of the application to change the marketing authorisation



On 13 January 2017, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Xgeva to be used to treat hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer).

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Xgeva (denosumab) (PDF/87.15 KB)

    First published: 27/01/2017
    Last updated: 27/01/2017

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

    How useful was this page?

    Add your rating