Belgium· BE-AMP-SAM520835-00
Zejula 100 mg
A niraparib product containing niraparib tosylate monohydrate, registered in Belgium by GlaxoSmithKline Trading Services. The same ATC class is registered in 14 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Niraparib is registered in 14 of 19 countries.
Countries holding a registration under ATC L01XK02 (niraparib), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 8 of them publish a price we can compare per daily dose
Niraparib · ATC L01XK02
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of niraparib costs, country by country.
Normalised to the WHO defined daily dose (0.3 g), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Niraparib · price per daily dose (0.3 g)
USD · FX 28 Sept 2026
- CH Switzerland$276.18
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Niraparib Tosylate Monohydrate
- Manufacturer
- GlaxoSmithKline Trading Services
- Country
- Belgium (BE)
- ATC code
- L01XK02
- ATC class
- Niraparib
- Defined daily dose
- 0.3 g, O
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
- be_apb7731730
- be_apb4323598
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
405 interactions on record for niraparib.
Graded by severity as the source publishes them — 29 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Niraparib · interactions on record
405 records
- 29 severe
- 376 moderate
Most severe, free to view
- CladribineL01BB04severe
- RolapitantA04AD14moderate
- LonafarnibA16AX20moderate
- DicoumarolB01AA01moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Niraparib 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 KingdomZejula 100mg capsulesOriginalis B.V.
- FinlandZejulaGlaxoSmithKline Trading Services Limited
- FranceZEJULA 100 mg, géluleGLAXOSMITHKLINE TRADING SERVICES (IRLANDE)
- IrelandZejula 100 mg Capsule, hardGlaxoSmithKline Trading Services Limited
- IcelandZejulaGlaxoSmithKline Trading Services Limited
- NetherlandsZejula 100 mg, harde capsulesGlaxoSmithKline Trading Services Limited
- PolandZejulaGlaxoSmithKline (Ireland) Limited
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/8cbe1ca4-0605-4099-8d89-7b57acf37f9d GET /v1/drugs/8cbe1ca4-0605-4099-8d89-7b57acf37f9d?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": "Capsule, hard",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Zejula 100 mg",
"name_fr": "Zejula 100 mg",
"name_nl": "Zejula 100 mg",
"amp_code": "SAM520835-00",
"strengths": [
"100.0000",
"100.0000",
"100.0000",
"0.0170",
"0.0170",
"254.5000",
"254.5000"
],
"pack_count": 3,
"substances": [
"Niraparib Tosylate Monohydrate",
"Niraparib",
"E 102",
"Lactose Monohydrate",
"Potassium Hydroxide",
"Propylene Glycol",
"Sodium Hydroxide"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Niraparib",
"authorisation_numbers": [
"EU/1/17/1235/001",
"EU/1/17/1235/002",
"EU/1/17/1235/003"
]
}See everything about niraparib.
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.