Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1887633
Name of medicinal product: ABIRATERONE MYLAN
Active substances:
Abiraterone
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: üksikannuseline blister
Indication: Abiraterone Mylan 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):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: September 14, 2022
Marketing authorization holder: Mylan Ireland Limited 
Marketing authorization number: EU/1/21/1571 
Marketing authorization issued on: August 20, 2021 
Marketing authorization expires on: September 1, 2026 
Marketing authorization procedure type: Centralised 
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: July 29, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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