Ireland· IE-PA-EU/1/23/1722/002
Akeega 100mg/500 mg Film-coated tablet
A niraparib and abiraterone product containing niraparib tosilate monohydrate + abiraterone acetate, registered in Ireland by Janssen-Cilag International NV. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Niraparib and abiraterone is registered in 11 of 19 countries.
Countries holding a registration under ATC L01XK52 (niraparib and abiraterone), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Niraparib and abiraterone · ATC L01XK52
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Norwayprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Niraparib Tosilate Monohydrate + Abiraterone acetate
- Manufacturer
- Janssen-Cilag International NV
- Country
- Ireland (IE)
- ATC code
- L01XK52
- ATC class
- Niraparib and abiraterone
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/23/1722/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Niraparib and abiraterone in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaAKEEGAJANSSEN INC
- SwitzerlandAkeega
- CzechiaAKEEGAJanssen-Cilag International N.V., Beerse
- SpainAKEEGA 100 MG/500 MG COMPRIMIDOS RECUBIERTOS CON PELICULAJanssen-Cilag International N.V
- FinlandAkeegaJanssen-Cilag International NV
- SwedenAkeega 100 mg/500 mg Filmdragerad tablettJanssen-Cilag International NV
- United StatesAKEEGAJanssen Biotech, Inc.
- United KingdomAkeega 100mg/500mg tabletsJanssen-Cilag Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Akeega
- Liechtenstein · Akeega
- Norway · Akeega
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/7c157419-9fdf-40f7-a5ac-fd3da75bb675 GET /v1/drugs/7c157419-9fdf-40f7-a5ac-fd3da75bb675?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"L01XK52"
],
"strength": null,
"pa_number": "EU/1/23/1722/002",
"substances": [
"Niraparib Tosilate Monohydrate",
"Abiraterone acetate"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "19/04/2023",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about niraparib and abiraterone.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.