Ketoconazole AID-SCFM:

Withdrawal of the marketing authorisation application

ketoconazole

Overview

On 23 February 2015, Agenzia Industrie Difesa - Stabilimento Chimico Farmaceutico Militare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ketoconazole AID-SCFM, for the treatment of Cushing's syndrome.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Ketoconazole AID-SCFM (ketoconazole) (PDF/73.16 KB)


    First published: 27/03/2015
    Last updated: 27/03/2015
    EMA/194831/2015

  • Key facts

    Name
    Ketoconazole AID-SCFM
    Product number
    EMEA/H/C/003800
    International non-proprietary name (INN) or common name
    • ketoconazole
    Active substance
    • Ketoconazole
    Date of withdrawal
    23/02/2015
    Company making the application
    Agenzia Industrie Difesa-Stabilimento Chimico Farmaceutico Militare
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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