Revlimid: Withdrawal of the application to change the marketing authorisation

lenalidomide

Overview

On 20 June 2012, Celgene Europe Ltd. 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 Revlimid, to extend its use to the treatment of patients with newly diagnosed multiple myeloma.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Revlimid (lenalidomide) (PDF/55.14 KB)


    First published: 06/07/2012
    Last updated: 24/07/2012
    EMA/414386/2012

  • Key facts

    Name
    Revlimid
    Product number
    EMEA/H/C/000717
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    14/06/2007
    International non-proprietary name (INN) or common name
    • lenalidomide
    Active substance
    • lenalidomide
    Date of withdrawal
    20/06/2012
    Company making the application
    Celgene Europe BV
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

    How useful was this page?

    Add your rating