Is Abiraterone + Niraparib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Abiraterone + Niraparib, including Akeega (50,500 mg,mg, Film-coated tablet, SAR 23027.20); Akeega (100,500 mg,mg, Film-coated tablet, SAR 23027.20).

Is Abiraterone + Niraparib approved by the US FDA?

Drugs@FDA lists 1 application product line for Abiraterone + Niraparib, including AKEEGA (Prescription).

Is Abiraterone + Niraparib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Abiraterone + Niraparib: Akeega.

Active substances

Abiraterone + Niraparib

SFDA 2
US FDA 1
EMA 1
Health Canada 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Akeega	50,500 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 23027.20	NCE · Prescription	Janssen-Cilag International NV	Valid
Akeega	100,500 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 23027.20	NCE · Prescription	Janssen-Cilag International NV	Valid

Indications — CHI Daman Drug Formulary

PROSTATE CANCER

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
AKEEGA	500MG;EQ 50MG BASE; 500MG;EQ 100MG BASE	tablet · oral	JANSSEN BIOTECH	Prescription	11 Aug 2023

EMA European Union — centrally authorised medicines

Akeega · Authorised · authorised 19 Apr 2023 · ATC L01

Therapeutic indication (EMA)

Treatment of adult patients with prostate cancer.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AKEEGA	02538555	50 MG; 500 MG	TABLET · ORAL	JANSSEN INC
AKEEGA	02538563	100 MG; 500 MG	TABLET · ORAL	JANSSEN INC

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.