Xgeva: Withdrawal of the application to change the marketing authorisation

denosumab

Overview

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
    EMA/47097/2017

  • Key facts

    Name
    Xgeva
    Product number
    EMEA/H/C/002173
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    13/07/2011
    International non-proprietary name (INN) or common name
    • denosumab
    Active substance
    • denosumab
    Date of withdrawal
    13/01/2017
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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