Product class: Authorized package
Medicinal product class: For human use
Package code: 1809671
Name of medicinal product: ISTURISA
Active substances:
Osilodrostat
Estonian, English, Latin
ATC code: H02CA02
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 1mg
Amount in package: 60TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Isturisa is indicated for the treatment of endogenous Cushing’s syndrome in adults.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
: 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: 09 January 2020 
Marketing authorization expires on: 13 January 2025 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: 09 April 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription