Erbitux: Withdrawal of the application to change the marketing authorisation

cetuximab

Overview

On 17 September 2012, Merck KGaA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Erbitux, to extend its use in the treatment of non-small-cell lung cancer.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) (PDF/50.95 KB)


    First published: 12/10/2012
    Last updated: 12/10/2012
    EMA/608075/2012

  • Key facts

    Name
    Erbitux
    Product number
    EMEA/H/C/000558
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    29/06/2004
    International non-proprietary name (INN) or common name
    • cetuximab
    Active substance
    • cetuximab
    Date of withdrawal
    17/09/2012
    Company making the application
    Merck KGaA
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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