Ibandronic Acid Hexal: Withdrawal of the marketing authorisation application

ibandronic acid

Overview

On 21 July 2011, Hexal AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibandronic Acid Hexal, for the prevention of skeletal events in patients with breast cancer and bone metastases.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Ibandronic Acid Hexal (PDF/64.09 KB)


    First published: 22/08/2011
    Last updated: 22/08/2011
    EMA/685524/2011

  • Key facts

    Name
    Ibandronic Acid Hexal
    Product number
    EMEA/H/C/002366
    International non-proprietary name (INN) or common name
    • ibandronic acid
    Active substance
    • ibandronic acid
    Date of withdrawal
    21/07/2011
    Company making the application
    Hexal AG
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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