XALKORI

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug XALKORI contains one active pharmaceutical ingredient (API):

1 Crizotinib UNII 53AH36668S - CRIZOTINIB

Crizotinib is a selective small-molecule inhibitor of the ALK receptor tyrosine kinase (RTK) and its oncogenic variants (i.e. ALK fusion events and selected ALK mutations). Crizotinib is also an inhibitor of the Hepatocyte Growth Factor Receptor (HGFR, c-Met) RTK, ROS1 (c-ros) and Recepteur d’Origine Nantais (RON) RTK. Read about Crizotinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XALKORI Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L01ED01	Crizotinib	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01ED Anaplastic lymphoma kinase (ALK) inhibitors
Discover more medicines within L01ED01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10322G, 10323H, 11589Y, 11594F
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 522720030084317, 522720030084417, 522720030084517, 522720030084617
Country: CA	Health Products and Food Branch	Identifier(s): 02384256, 02384264
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): H7020913
Country: EE	Ravimiamet	Identifier(s): 1597541, 1597552
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 112793001, 112793003
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 073313, 081305
Country: FR	Base de données publique des médicaments	Identifier(s): 61506083, 66937155
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 215964, 215984, 392920, 392922
Country: HK	Department of Health Drug Office	Identifier(s): 61968, 61969
Country: IE	Health Products Regulatory Authority	Identifier(s): 88783, 88784
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6927, 6928
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291026M1023, 4291026M2020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1068261, 1068262, 1068263, 1068264
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 104507, 104515
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 16912, 16913
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100285117, 100285146
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64866001, W64867001
Country: SG	Health Sciences Authority	Identifier(s): 14247P, 14248P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 20473021H, 20473022H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8681308159151, 8681308159168
Country: US	FDA, National Drug Code	Identifier(s): 0069-8140, 0069-8141
Country: ZA	Health Products Regulatory Authority	Identifier(s): 47/26/0568, 47/26/0569