Ketoconazole HRA

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ketoconazole

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Ketoconazole HRA. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ketoconazole HRA.

For practical information about using Ketoconazole HRA, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 14/12/2017

Authorisation details

Product details
Name
Ketoconazole HRA
Agency product number
EMEA/H/C/003906
Active substance
Ketoconazole
International non-proprietary name (INN) or common name
ketoconazole
Therapeutic area (MeSH)
Cushing Syndrome
Anatomical therapeutic chemical (ATC) code
J02AB02
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Laboratoire HRA Pharma
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
18/11/2014
Contact address
15 rue Béranger
75003 Paris
France

Product information

22/08/2017 Ketoconazole HRA - EMEA/H/C/003906 - PSUSA/00010316/201611

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIMYCOTICS FOR SYSTEMIC USE

Therapeutic indication

Ketoconazole HRA is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.

Assessment history

Changes since initial authorisation of medicine

  • List item

    Ketoconazole HRA-H-C-PSUSA-00010316-201605 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.8 KB)


    First published: 14/12/2017
    Last updated: 14/12/2017
    EMA/155248/2017

  • List item

    Ketoconazole HRA-H-C-PSUSA-00010316-201611 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/70.8 KB)


    First published: 14/12/2017
    Last updated: 14/12/2017
    EMA/830677/2017

  • List item

    Ketoconazole HRA-H-C-PSUSA-00010316-201605 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.8 KB)


    First published: 03/03/2017
    Last updated: 03/03/2017
    EMA/155248/2017

  • List item

    Ketoconazole HRA-H-C-PSUSA-00010316-201511 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.83 KB)


    First published: 25/11/2016
    Last updated: 25/11/2016
    EMA/789888/2016

  • List item

    Ketoconazole HRA-H-C-PSUSA-00010316-201505 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.02 KB)


    First published: 11/03/2016
    Last updated: 11/03/2016
    EMA/CHMP/41543/2016

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