Belgium· BE-AMP-SAM661506-00
Akeega 50 mg - 500 mg
A niraparib and abiraterone product containing niraparib tosylate monohydrate, registered in Belgium by Janssen-Cilag International. The same ATC class is registered in 11 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Niraparib Tosylate Monohydrate
- Manufacturer
- Janssen-Cilag International
- Country
- Belgium (BE)
- ATC code
- L01XK52
- ATC class
- Niraparib and abiraterone
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
- be_apb4728069
- be_apb7740483
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Niraparib and abiraterone in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaZEJULAGlaxoSmithKline Trading Services Limited, Dublin
- United StatesZEJULAGlaxoSmithKline LLC
- United KingdomZejula 100mg capsulesOriginalis B.V.
- SpainZEJULA 100 MG CAPSULAS DURASGlaxosmithkline Trading Services Limited
- SwedenZejula 100 mg Filmdragerad tablettGlaxoSmithKline Trading Services Ltd
- FranceZEJULA 100 mg, comprimé pelliculéGLAXOSMITHKLINE TRADING SERVICES (IRLANDE)
- PolandZejulaGlaxoSmithKline (Ireland) Limited
- SwitzerlandZejula 100 mg, FilmtablettenGlaxoSmithKline AG
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Zejula
- Liechtenstein · Zejula
- Norway · Zejula
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 FAMHP / AFMPS (Belgium). 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/e2172daf-bcc9-4225-bdf2-6c398f9cc688 GET /v1/drugs/e2172daf-bcc9-4225-bdf2-6c398f9cc688?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Akeega 50 mg - 500 mg",
"name_fr": "Akeega 50 mg - 500 mg",
"name_nl": "Akeega 50 mg - 500 mg",
"amp_code": "SAM661506-00",
"strengths": [
"500.0000",
"50.0000",
"446.0000",
"500.0000",
"446.0000",
"50.0000",
"241.0000"
],
"pack_count": 1,
"substances": [
"Niraparib Tosylate Monohydrate",
"Abiraterone Acetate",
"Niraparib",
"Abiraterone",
"Lactose",
"Sodium Laurilsulfate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Niraparib and Abiraterone",
"authorisation_numbers": [
"EU/1/23/1722/001"
]
}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.