Lenalidomide Celgene Europe: Withdrawal of the marketing authorisation application



On 30 May 2008, Celgene Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lenalidomide Celgene Europe, for the treatment of anaemia due to myelodysplastic syndromes. Lenalidomide Celgene Europe was designated as an orphan medicinal product on 8 March 2004.

  • List item

    Questions and answers on the withdrawal of the marketing application for Lenalidomide Celgene Europe (PDF/43.52 KB)

    First published: 03/07/2008
    Last updated: 03/07/2008

  • Key facts

    Lenalidomide Celgene Europe
    Product number
    International non-proprietary name (INN) or common name
    • lenalidomide
    Active substance
    • lenalidomide
    Date of withdrawal
    Company making the application
    Celgene Europe Limited
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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