Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AKEEGA
Active substances:
Niraparib+Abiraterone
Estonian, English, Latin
ATC code: L01XK52
Dosage form: film-coated tablet
Strength: 100mg+500mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
3037193  AKEEGA  film-coated tablet  100mg +500mg 56TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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