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

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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