Velcade: Withdrawal of the application to change the marketing authorisation

bortezomib

Overview

On 2 July 2012, Janssen-Cilag International N.V. 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 of Velcade, which would have extended its use to patients with relapsed follicular non-Hodgkin lymphoma.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) (PDF/80.01 KB)


    First published: 31/07/2012
    Last updated: 31/07/2012
    EMA/454020/2012

  • Key facts

    Name
    Velcade
    Product number
    EMEA/H/C/000539
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    26/04/2004
    International non-proprietary name (INN) or common name
    • bortezomib
    Active substance
    • bortezomib
    Date of withdrawal
    02/07/2012
    Company making the application
    Janssen-Cilag International NV
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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