🇪🇺 GSK189075 in European Union

EMA authorised GSK189075 on 18 November 2014

Marketing authorisations

EMA — authorised 18 November 2014

  • Application: EMEA/H/C/003906
  • Marketing authorisation holder: Esteve Pharmaceuticals, S.A.
  • Local brand name: Ketoconazole Esteve (previously Ketoconazole HRA)
  • Indication: Ketoconazole Esteve is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.
  • Pathway: accelerated assessment
  • Status: approved

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EMA — authorised 10 April 2015

  • Application: EMEA/H/C/003800
  • Marketing authorisation holder: Agenzia Industrie Difesa-Stabilimento Chimico Farmaceutico Militare
  • Local brand name: Ketoconazole AID-SCFM
  • Indication: Treatment of Cushings syndrome
  • Status: withdrawn

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Frequently asked questions

Is GSK189075 approved in European Union?

Yes. EMA authorised it on 18 November 2014; EMA authorised it on 10 April 2015.

Who is the marketing authorisation holder for GSK189075 in European Union?

Esteve Pharmaceuticals, S.A. holds the EU marketing authorisation.