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Medicines
Spain
Niraparib

AEMPS 2026

Niraparib

Zejula 100 MG Comprimidos Recubiertos con Pelicula

100 mg comprimido recubierto con películaSpainAuthorisedAuthorised 16 Jun 2026

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

ZejulaBrazil · Glaxosmithkline Brasil LtdaSame brand
ZejulaBrazil · Glaxosmithkline Brasil LtdaSame brand
ZejulaCanada · 100 MG · Tablet · Glaxosmithkline INCSame brand
ZejulaCanada · 100 MG · Capsule · Glaxosmithkline INCSame brand
ZejulaEuropean Union · GlaxoSmithKline Trading Services LimitedSame brand
ZejulaCroatiaSame brand
ZejulaItaly · Compressa rivestita con film · Glaxosmithkline Trading Services LimitedSame brand
Zejula 100 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · GlaxoSmithKline Trading Services Limited

More with the same substance on this register

Zejula 100 MG Comprimidos Recubiertos con PeliculaNiraparib · 159,3 mg · comprimido recubierto con películaSpain
Zejula 100 MG Capsulas DurasNiraparib · 159.40 mg · cápsula duraSpain

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Same brand

🇳🇱Zejula 100 mg, harde capsulesNetherlands · Capsule, hard · GlaxoSmithKline Trading Services LimitedSame brand

🇳🇿ZejulaNew Zealand · Tab 100 mgSame brand

🇸🇬Zejula Film-Coated Tablet 100MGSingapore · 100mg · tablet, film coated · Glaxosmithkline Pte LTDSame brand

🇸🇬Zejula Film-Coated Tablet 200MGSingapore · 200mg · tablet, film coated · Glaxosmithkline Pte LTDSame brand

🇺🇸ZejulaUnited States · 100MG BASE, 200MG BASE, 300MG BASE · tablet · GlaxosmithklineSame brand

🇺🇸ZejulaUnited States · 100MG BASE · capsule · GlaxosmithklineSame brand

Packs

Pack	Code	Status
ZEJULA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 84 comprimidos	770825

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Niraparib
Strength: 100 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 16 Jun 2026
Registration: 1171235006IP
Marketing authorisation holder: Glaxosmithkline Trading Services Limited
Procedure: EU centralised
Supply: Diagnóstico Hospitalario