Is Lorlatinib 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 Lorlatinib, including LORBRENA (100 mg, Film-coated tablet, SAR 19267.10); LORBRENA (25 mg, Film-coated tablet, SAR 6422.35).

Is Lorlatinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Lorlatinib, including LORBRENA (Prescription).

Is Lorlatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lorlatinib: Lorviqua.

Are there safety signals or safety updates for Lorlatinib?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-01-29).

Active substance

Lorlatinib

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
LORBRENA	100 mg	Film-coated tablet · Oral use	30 Bottle	SAR 19267.10	NCE · Prescription	PFIZER INC	Valid
LORBRENA	25 mg	Film-coated tablet · Oral use	30 Bottle	SAR 6422.35	NCE · Prescription	PFIZER INC	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
LORBRENA	25MG; 100MG	tablet · oral	PFIZER	Prescription	2 Nov 2018

EMA European Union — centrally authorised medicines

Lorviqua Pfizer Europe MA EEIG · Authorised · authorised 6 May 2019 · ATC L01ED05

Therapeutic indication (EMA)

Lorviqua as monotherapy is indicated 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. Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK?positive advanced NSCLC whose disease has progressed after: alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LORBRENA	02485966	25 MG	TABLET · ORAL	PFIZER CANADA ULC
LORBRENA	02485974	100 MG	TABLET · ORAL	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 29 Jan 2026 LORBRENA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 13 Feb 2020 PRAC signal: Nephrotic syndrome
Action for MAH: update of the product information: No

All safety entries for lorlatinib →

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.