Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 3037182
Name of medicinal product: AKEEGA
Active substances:
Niraparib+Abiraterone
Estonian, English, Latin
ATC code: L01XK52
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 50mg+500mg
Amount in package: 56TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Akeega is indicated with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Janssen - Cilag International 
Marketing authorization number: EU/1/23/1722 
Marketing authorization issued on: April 19, 2023 
Marketing authorization expires on: April 20, 2028 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 5, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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