Is Niraparib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Niraparib, including Zejula (100 mg, Film-coated tablet, SAR 15657.10).

Is Niraparib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Niraparib, including ZEJULA (Prescription); ZEJULA (Discontinued).

Is Niraparib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Niraparib: Zejula.

Are there safety signals or safety updates for Niraparib?

EMA PRAC: 2 entries; US FDA: 3 entries; MHRA: 1 entry (latest 2025-12-12).

Active substance

Niraparib

SFDA 1
US FDA 2
EMA 1
Health Canada 1
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Zejula	100 mg	Film-coated tablet · Oral use	56 Blister	SAR 15657.10	NCE · Prescription	GLAXO SAUDI ARABIA	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZEJULA	EQ 100MG BASE; EQ 200MG BASE; EQ 300MG BASE	tablet · oral	GLAXOSMITHKLINE	Prescription	26 Apr 2023
ZEJULA	EQ 100MG BASE	capsule · oral	GLAXOSMITHKLINE	Discontinued	27 Mar 2017

EMA European Union — centrally authorised medicines

Zejula GlaxoSmithKline Trading Services Limited · Authorised · authorised 16 Nov 2017 · ATC L01XK02

Therapeutic indication (EMA)

Zejula is indicated: as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ZEJULA	02530031	100 MG	TABLET · ORAL	GLAXOSMITHKLINE INC

Safety signals and safety-related labeling changes

US FDA 12 Dec 2025 AKEEGA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jun 2025 ZEJULA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Apr 2023 ZEJULA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 22 Oct 2020 Niraparib (Zejula▼): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment
Increase the frequency of blood pressure monitoring to at least weekly for the first 2 months, and then monitor monthly for the first year and periodically thereafter during treatment, following recent reports of onset of severe hypertension (including rare cases of hypertensive crisis) and rare cases of PRES within the first month of niraparib treatment.
EMA PRAC 31 Oct 2018 PRAC signal: Sepsis
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Potential occurrence of embolic and thrombotic events
Action for MAH: update of the product information: No

All safety entries for niraparib →

Combinations containing Niraparib

Abiraterone + niraparib

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.