Is Neratinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Neratinib, including NERLYNX (40 mg, Film-coated tablet, SAR 17522.95); Speranta (40 mg, Film-coated tablet, SAR 11389.90).

Is Neratinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Neratinib, including NERLYNX (Prescription).

Is Neratinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Neratinib: Nerlynx.

Are there safety signals or safety updates for Neratinib?

US FDA: 1 entry (latest 2021-06-28).

Active substance

Neratinib

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NERLYNX	40 mg	Film-coated tablet · Oral use	180 Bottle	SAR 17522.95	NCE · Prescription	PIERRE FABRE MEDICAMENT	Valid
Speranta	40 mg	Film-coated tablet · Oral use	180 Bottle	SAR 11389.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
NERLYNX	EQ 40MG BASE	tablet · oral	PUMA BIOTECH	Prescription	17 Jul 2017

EMA European Union — centrally authorised medicines

Nerlynx Pierre Fabre Medicament · Authorised · authorised 31 Aug 2018 · ATC L01EH02

Therapeutic indication (EMA)

Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NERLYNX	02490536	40 MG	TABLET · ORAL	KNIGHT THERAPEUTICS INC.

Safety signals and safety-related labeling changes

US FDA 28 Jun 2021 NERLYNX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for neratinib →

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.