Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ABIRATERONE KRKA
Active substances:
Abiraterone
Estonian, English, Latin
ATC code: L02BX03
Dosage form: film-coated tablet
Strength: 500mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Abiraterone Krka 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 docetaxelbased chemotherapy regimen.
Safety features: Yes
Marketing authorization holder: KRKA d.d. Novo mesto 
Marketing authorization number: EU/1/21/1553 
Marketing authorization issued on: June 24, 2021 
Marketing authorization expires on: June 28, 2026 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1856101  ABIRATERONE KRKA  film-coated tablet  500mg 56TK  Prescription           
1856112  ABIRATERONE KRKA  film-coated tablet  500mg 60TK  Prescription           
1856123  ABIRATERONE KRKA  film-coated tablet  500mg 56TK  Prescription          taskublister 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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