Ketoconazole Esteve (previously Ketoconazole HRA) (ketoconazole)
Accelerated assessmentAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- ketoconazole
- Company
- Esteve Pharmaceuticals, S.A.
- Status
- Authorised
- Therapeutic area
- Cushing Syndrome
- EU approval
- Tue 18 Nov 2014
- Designations
- Accelerated assessment, Additional monitoring
- Application
- EMEA/H/C/003906
- ATC
- H02CA03
- Official record
- www.ema.europa.eu
Indication
Ketoconazole Esteve is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ketoconazole AID-SCFM Application withdrawn · Agenzia Industrie Difesa-Stabilimento Chimico Farmaceutico Militare
Follow Ketoconazole Esteve (previously Ketoconazole HRA)
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.