France· FR:61096104
ZEJULA 100 mg, comprimé pelliculé
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- cip133400930254035plaquette(s) thermoformée(s) OPA : polyamide orienté aluminium PVC-Aluminium vinyle acrylique papier de 56 comprimé(s)EUR 3.41
- cip133400930254042plaquette(s) thermoformée(s) OPA : polyamide orienté aluminium PVC-Aluminium vinyle acrylique papier de 84 comprimé(s)EUR 5.05
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
- SwitzerlandZejula 100 mg, FilmtablettenGlaxoSmithKline AG
- SpainZEJULA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULAGlaxosmithkline Trading Services Limited
- BelgiumAkeega 100 mg - 500 mgJanssen-Cilag International
- United StatesZEJULAGlaxoSmithKline LLC
- IcelandZejulaGlaxoSmithKline Trading Services Limited
- NetherlandsZejula 100 mg, filmomhulde tabletGlaxoSmithKline Trading Services Limited
- NorwayZejulaGlaxoSmithKline Trading Services 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 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/738585d1-bd1c-48d7-ade4-3ee76534a578 GET /v1/drugs/738585d1-bd1c-48d7-ade4-3ee76534a578?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": "61096104",
"date_amm": "2022-05-30",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/17/1235/",
"substance": "TOSYLATE DE NIRAPARIB MONOHYDRATÉ",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "comprimé pelliculé",
"voies_administration": "orale",
"etat_commercialisation": "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.