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.
Therapeutic Indication
### Therapeutic indication Ketoconazole Esteve is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.
Therapeutic Area (MeSH)
ATC Code
J02AB02
ATC Item
ketoconazole
Pharmacotherapeutic Group
Antimycotics for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Ketoconazole | N/A | 酮康唑 |
EMA Name
Ketoconazole HRA
Medicine Name
Ketoconazole Esteve (previously Ketoconazole HRA)
Aliases
N/ANo risk management plan link.
