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KETOCONAZOLE HRA (ketoconazole), imidazole

ENDOCRINOLOGY - New medicinal product
Opinions on drugs - Posted on Sep 15 2015

Reason for request


Minor improvement in the management of endogenous Cushing’s syndrome in patients aged over 12 years


  • KETOCONAZOLE HRA has Marketing Authorisation in the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years. 
  • In retrospective studies with a number of methodological limitations, its efficacy was demonstrated by a reduction in 24-hour urinary free cortisol and in clinical symptoms and comorbidities, in particular arterial hypertension and diabetes.
  • Because of the known hepatic toxicity of ketoconazole, regular monitoring of liver function and tailoring of the dosage are essential.

Clinical Benefit



Clinical Added Value



Therapeutic use


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