Ketoconazole HRA
ketoconazole
Table of contents
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.
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Ketoconazole HRA : EPAR - Summary for the public (PDF/83.5 KB)
First published: 30/01/2015
Last updated: 30/01/2015
EMA/43347/2015 -
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Ketoconazole HRA : EPAR - Risk-management-plan summary (PDF/172.24 KB)
First published: 30/01/2015
Last updated: 18/09/2019
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
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
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 | |
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Marketing-authorisation holder |
HRA Pharma Rare Diseases
|
Revision |
10
|
Date of issue of marketing authorisation valid throughout the European Union |
18/11/2014
|
Contact address |
200 avenue de Paris |
Product information
20/04/2021 Ketoconazole HRA - EMEA/H/C/003906 - IA/0018
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.