Is Crizotinib 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 Crizotinib, including XALKORI 200MG CAPSULE (200 mg, Capsule, hard, SAR 14478.75); XALKORI 250MG CAPSULE (250 mg, Capsule, hard, SAR 14478.75).

Is Crizotinib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Crizotinib, including XALKORI (Prescription); XALKORI (Prescription).

Is Crizotinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Crizotinib: Xalkori.

Are there safety signals or safety updates for Crizotinib?

US FDA: 1 entry; MHRA: 1 entry (latest 2023-09-07).

Active substance

Crizotinib

SFDA 2
US FDA 2
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
XALKORI 200MG CAPSULE	200 mg	Capsule, hard · Oral use	60 Bottle	SAR 14478.75	NCE · Prescription	PFIZER	Valid
XALKORI 250MG CAPSULE	250 mg	Capsule, hard · Oral use	60 Bottle	SAR 14478.75	NCE · Prescription	PFIZER	Valid

Indications — CHI Daman Drug Formulary

NON-SMALL-CELL LUNG CARCINOMA (NSCLC); T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
XALKORI	200MG; 250MG	capsule · oral	PF PRISM CV	Prescription	26 Aug 2011
XALKORI	20MG; 50MG; 150MG	capsule, pellets · oral	PF PRISM CV	Prescription	7 Sep 2023

EMA European Union — centrally authorised medicines

Xalkori Pfizer Europe MA EEIG · Authorised · authorised 23 Oct 2012 · ATC L01ED01

Therapeutic indication (EMA)

Xalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with ROS1 positive advanced non small cell lung cancer (NSCLC) The treatment of paediatric patients (age 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL) The treatment of paediatric patients (age 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
XALKORI	02384256	200 MG	CAPSULE · ORAL	PFIZER CANADA ULC
XALKORI	02384264	250 MG	CAPSULE · ORAL	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 7 Sep 2023 XALKORI — 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
MHRA 12 Nov 2015 Crizotinib (Xalkori▼): risk of cardiac failure
There have been reports of severe, sometimes fatal, cases of cardiac failure in patients treated with crizotinib.

All safety entries for crizotinib →

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.