Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1801055
Name of medicinal product: ABIRATERONE G.L. PHARMA
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:  
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 June 3, 2021)
Package information leaflet (PIL): EST  (last updated June 3, 2021)
Labelling:  (last updated June 3, 2021)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: G.L. Pharma GmbH 
Marketing authorization number: 1031821 
Marketing authorization issued on: June 3, 2021 
Marketing authorization expires on: June 3, 2026 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: June 3, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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