Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1829998
Name of medicinal product: ABIRATERONE ZENTIVA
Active substances:
Estonian, English, Latin
ATC code: L02BX03
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 500mg
Amount in package: 60TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: [Product name] 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 November 30, 2021)
Package information leaflet (PIL): EST  (last updated November 30, 2021)
Labelling:  (last updated November 30, 2021)
Last imported to Estonia: September 23, 2022
Marketing authorization holder: Zentiva k.s. 
Marketing authorization number: 1046921 
Marketing authorization issued on: November 30, 2021 
Marketing authorization expires on: November 30, 2026 
Marketing authorization procedure type: Decentralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  01.10.2022     Yes  C61-C61  Uroloog, Onkoloog  No      
100  01.10.2022     Yes  C61-C61  Uroloog, Onkoloog  No  until 4 years   
Reference price: 740,70 EUR 
Under reference price: Yes 
Reference price of daily dose: 24,69 EUR 
Entry/Changing date: March 24, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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