Is Brigatinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Brigatinib, including ALUNBRIG (180 mg, Film-coated tablet, SAR 17627.50); ALUNBRIG (90 mg, Film-coated tablet, SAR 13358.70); ALUNBRIG (30 mg, Film-coated tablet, SAR 4452.75).

Is Brigatinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Brigatinib, including ALUNBRIG (Prescription).

Is Brigatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Brigatinib: Alunbrig.

Are there safety signals or safety updates for Brigatinib?

US FDA: 1 entry (latest 2022-02-28).

Active substance

Brigatinib

SFDA 4
US FDA 1
EMA 1
Health Canada 4
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
ALUNBRIG	180 mg	Film-coated tablet · Oral use	28 Blister	SAR 17627.50	NCE · Prescription	TAKEDA PHARMA A/S	Valid
ALUNBRIG	90 mg	Film-coated tablet · Oral use	28 Blister	SAR 13358.70	NCE · Prescription	TAKEDA PHARMA A/S	Valid
ALUNBRIG	30 mg	Film-coated tablet · Oral use	28 Blister	SAR 4452.75	NCE · Prescription	TAKEDA PHARMA A/S	Valid
ALUNBRIG	90 mg	Film-coated tablet · Oral use	7 Blister	SAR 3710.65	NCE · Prescription	TAKEDA PHARMA A/S	Valid

Indications — CHI Daman Drug Formulary

NON-SMALL-CELL LUNG CARCINOMA (NSCLC)

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

Product	Strength	Form · route	Applicant	Status	First approved
ALUNBRIG	30MG; 90MG; 180MG	tablet · oral	TAKEDA PHARMS USA	Prescription	28 Apr 2017

EMA European Union — centrally authorised medicines

Alunbrig Takeda Pharma A/S · Authorised · authorised 22 Nov 2018 · ATC L01XE43

Therapeutic indication (EMA)

Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALUNBRIG	02479206	30 MG	TABLET · ORAL	TAKEDA CANADA INC
ALUNBRIG	02479214	90 MG	TABLET · ORAL	TAKEDA CANADA INC
ALUNBRIG	02479222	180 MG	TABLET · ORAL	TAKEDA CANADA INC
ALUNBRIG	02479230	180 MG; 90 MG	TABLET; KIT · ORAL	TAKEDA CANADA INC

Safety signals and safety-related labeling changes

US FDA 28 Feb 2022 ALUNBRIG — 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 brigatinib →

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.