France· FR:67707919
ZEJULA 100 mg, gélule
A medicinal product containing tosylate de niraparib monohydraté, registered in France by GLAXOSMITHKLINE TRADING SERVICES (IRLANDE), on the national reimbursement list.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- TOSYLATE DE NIRAPARIB MONOHYDRATÉ
- Manufacturer
- GLAXOSMITHKLINE TRADING SERVICES (IRLANDE)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 2
2 priced- cip13340093012668484 plaquette(s) thermoformée(s) (ACLAR RX) polytrifluorochloroéthylène PVC aluminium de 1 gélule(s)EUR 5.05
- cip13340093013085856 plaquette(s) thermoformée(s) (ACLAR RX) polytrifluorochloroéthylène PVC aluminium de 1 gélule(s)EUR 3.41
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tosylate de niraparib monohydraté 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 capsulesGlaxoSmithKline UK Ltd
- FinlandZejulaGlaxoSmithKline Trading Services Limited
- IrelandZejula 100 mg Capsule, hardGlaxoSmithKline Trading Services Limited
- 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 Base de données publique des médicaments — BDPM (France). 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/fff1627d-4316-4264-9247-8fb728279968 GET /v1/drugs/fff1627d-4316-4264-9247-8fb728279968?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.
{
"cis": "67707919",
"date_amm": "2017-11-16",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/17/1235",
"substance": "TOSYLATE DE NIRAPARIB MONOHYDRATÉ",
"statut_amm": "Autorisation active",
"statut_bdm": "Warning disponibilité",
"forme_pharmaceutique": "gélule",
"voies_administration": "orale",
"etat_commercialisation": "Non commercialisée",
"surveillance_renforcee": "Non"
}See everything about tosylate de niraparib monohydraté.
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.