Jenzyl: Withdrawal of the marketing authorisation application

ridaforolimus

Overview

On 27 November 2012, Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Jenzyl, for the maintenance treatment of patients with metastatic soft-tissue sarcoma or bone sarcoma previously treated with chemotherapy.

  • List item

    Questions and answers on the withdrawal of the marketing-authorisation application for Jenzyl (ridaforolimus) (PDF/76.74 KB)


    First published: 14/12/2012
    Last updated: 18/02/2013
    EMA/807998/2012

  • Key facts

    Name
    Jenzyl
    Product number
    EMEA/H/C/002259
    International non-proprietary name (INN) or common name
    • ridaforolimus
    Active substance
    • ridaforolimus
    Date of withdrawal
    27/11/2012
    Company making the application
    Merck Sharp and Dohme Ltd.
    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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