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.

ATC L01XK02

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedZejula 100 mgATCL01XK02REGISTER NO.BE-AMP-SAM520835-00PACKS LISTED2CHECKEDSeptember 26, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

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_apb
    7731730
  • be_apb
    4323598

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All niraparib products

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.