Loulla: Withdrawal of the marketing authorisation application



On 19 December 2012, Only For Children Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Loulla, for the maintenance treatment of acute lymphoblastic leukaemia.

  • List item

    Questions and answers on the withdrawal of the marketing-authorisation application for Loulla (PDF/77.31 KB)

    First published: 18/01/2013
    Last updated: 18/02/2013

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • mercaptopurine
    Date of withdrawal
    Company making the application
    Only For Children Pharmaceuticals
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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