Ireland· IE-PA-EU/1/17/1235/001-003
Zejula 100 mg Capsule, hard
A niraparib product containing niraparib tosylate monohydrate, registered in Ireland by GlaxoSmithKline Trading Services Limited.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Niraparib tosylate monohydrate
- Manufacturer
- GlaxoSmithKline Trading Services Limited
- Country
- Ireland (IE)
- ATC code
- L01XX54
- ATC class
- Niraparib
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/17/1235/001-003
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)
- IcelandZejulaGlaxoSmithKline Trading Services Limited
- NetherlandsZejula 100 mg, harde capsulesGlaxoSmithKline Trading Services Limited
- PolandZejulaGlaxoSmithKline (Ireland) Limited
- BelgiumZejula 100 mgGlaxoSmithKline Trading Services
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 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/796b49c3-c3dc-427b-864a-9f56859490ce GET /v1/drugs/796b49c3-c3dc-427b-864a-9f56859490ce?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",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"L01XX",
"L01XX54"
],
"strength": null,
"pa_number": "EU/1/17/1235/001-003",
"substances": [
"Niraparib tosylate monohydrate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "16/11/2017",
"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.
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.