Arzerra: Withdrawal of the application to change the marketing authorisation

ofatumumab

Overview

On 8 November 2016, Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Arzerra to be used in a new combination with bendamustine for the treatment of relapsed chronic lymphocytic leukaemia (CLL).

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Arzerra (ofatumumab) (PDF/82.14 KB)


    First published: 16/12/2016
    Last updated: 16/12/2016
    EMA/847130/2016

  • Key facts

    Name
    Arzerra
    Product number
    EMEA/H/C/001131
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    19/04/2010
    International non-proprietary name (INN) or common name
    • ofatumumab
    Active substance
    • Ofatumumab
    Date of withdrawal
    08/11/2016
    Company making the application
    Novartis Europharm Ltd
    Withdrawal type
    Post-authorisation

    All documents

    Related content

    Related information on withdrawals

    This text will be replaced by the description of taxonomy term "Template for related information on withdrawals" from vocabulary "String replacement".

    How useful was this page?

    Add your rating
    Average
    1 rating
    1 rating