LekInfoFrench medicines reference
My list0
Structural formula: NiraparibStructural formula: Niraparib

ZEJULA 100 mg, hard capsule 84 capsules

Active ingredients: Niraparib, Niraparib tosylate monohydrate

Commercialized according to BDPMDispensing in France: Prescription only
Hard capsule84 capsulesorale

No current ANSM shortage notice is included

Package details

Original BDPM fields are shown in French.

Official name
ZEJULA 100 mg, gélule
Pharmaceutical form
gélule
Route of administration
orale
Presentation description
84 plaquette(s) thermoformée(s) (ACLAR RX) polytrifluorochloroéthylène PVC aluminium de 1 gélule(s)
Marketing authorisation holder
GLAXOSMITHKLINE TRADING SERVICES (IRLANDE)
Reimbursement according to BDPM
100%
Approval for use in healthcare institutions
non
Commercialization declaration date
12 Aug 2024
Prescription and dispensing conditions
Prescription only
  • List I: prescription-only medicine
  • Requires special monitoring during treatment
  • Prescribed by a hospital doctor
  • Prescribed by specialists only
Original BDPM wording: liste I · médicament nécessitant une surveillance particulière pendant le traitement · prescription hospitalière · prescription réservée aux médecins compétents en CANCEROLOGIE · prescription réservée aux spécialistes et services ONCOLOGIE MEDICALE
Enhanced ANSM monitoring
No

BDPM identifiers

CIS67707919CIP73012668CIP133400930126684

Composition in BDPM

Composition in BDPM
ComponentAmount per unitSource type
TOSYLATE DE NIRAPARIB MONOHYDRATÉgélule—SA
NIRAPARIBgélule100 mg · une géluleFT

Information is based on BDPM data and is for reference only. Consult a doctor before use.

Other packages of this medicine

The same medicine in another pack size, according to BDPM.

Similar medicines

Similar medicines are listed using the official BDPM catalog. Availability must be checked separately. Consult a doctor or pharmacist before switching medicines.

The current BDPM data does not list similar medicines for this product.