Product class: Authorized package
Medicinal product class: For human use
Package code: 1814701
Name of medicinal product: ABIRATERONE SANDOZ
Active substances:
Estonian, English, Latin
ATC code: L02BX03
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 1000mg
Amount in package: 28TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: is indicated with prednisone or prednisolone for: • the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) • the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated 06 July 2021)
Package information leaflet (PIL): EST  (last updated 06 July 2021)
Labelling:  (last updated 25 October 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 1034821 
Marketing authorization issued on: 06 July 2021 
Marketing authorization expires on: 06 July 2026 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 27 October 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription