Isomarv medium: Withdrawal of the marketing authorisation application

insulin human

Overview

On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Isomarv medium, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.

  • List item

    Questions and answers on the withdrawal of the marketing-authorisation application for Isomarv (human insulin) (PDF/61.51 KB)


    First published: 14/12/2012
    Last updated: 14/12/2012
    EMA/CHMP/800910/2012

  • Key facts

    Name
    Isomarv medium
    Product number
    EMEA/H/C/002610
    International non-proprietary name (INN) or common name
    • insulin human
    Active substance
    • insulin human
    Date of withdrawal
    15/11/2012
    Company making the application
    Marvel Life Sciences 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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