Is Lazertinib 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 Lazertinib, including Lazcluze (240 mg, Film-coated tablet, SAR 28729.50); Lazcluze (80 mg, Film-coated tablet, SAR 28729.50).

Is Lazertinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Lazertinib, including LAZCLUZE (Prescription).

Is Lazertinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lazertinib: Lazcluze.

Are there safety signals or safety updates for Lazertinib?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-09-03).

Active substance

Lazertinib

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Lazcluze	240 mg	Film-coated tablet · Oral use	30 Bottle	SAR 28729.50	Prescription	Janssen-Cilag International NV	Valid
Lazcluze	80 mg	Film-coated tablet · Oral use	60 Bottle	SAR 28729.50	NCE · Prescription	Janssen-Cilag International NV	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
LAZCLUZE	EQ 80MG BASE; EQ 240MG BASE	tablet · oral	JANSSEN BIOTECH	Prescription	19 Aug 2024

EMA European Union — centrally authorised medicines

Lazcluze Janssen Cilag International NV · Authorised · authorised 20 Jan 2025 · ATC L01EB09

Therapeutic indication (EMA)

Lazcluze in combination with amivantamab is indicated for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LAZCLUZE	02555964	80 MG	TABLET · ORAL	JANSSEN INC
LAZCLUZE	02555972	240 MG	TABLET · ORAL	JANSSEN INC

Safety signals and safety-related labeling changes

EMA PRAC 3 Sep 2026 PRAC signal: Colitis
Action for MAH: update of the product information: No
US FDA 30 Apr 2026 LAZCLUZE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for lazertinib →

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.