Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ISTURISA
Active substances:
Osilodrostat
Estonian, English, Latin
ATC code: H02CA02
Dosage form: film-coated tablet
Strength: 1mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Isturisa is indicated for the treatment of endogenous Cushing’s syndrome in adults.
Safety features: Yes
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Recordati Rare Diseases 
Marketing authorization number: EU/1/19/1407 
Marketing authorization issued on: January 9, 2020 
Marketing authorization expires on: January 13, 2025 
Marketing authorization procedure type: Centralised 
Assessment report:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1809671  ISTURISA  film-coated tablet  1mg 60TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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