XALKORI

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

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 more about Crizotinib

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	10322G, 10323H, 11589Y, 11594F
BR	Câmara de Regulação do Mercado de Medicamentos	522720030084317, 522720030084417, 522720030084517, 522720030084617
CA	Health Products and Food Branch	02384256, 02384264
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	H7020913
EE	Ravimiamet	1597541, 1597552
ES	Centro de información online de medicamentos de la AEMPS	112793001, 112793003
FI	Lääkealan turvallisuus- ja kehittämiskeskus	073313, 081305
FR	Base de données publique des médicaments	61506083, 66937155
GB	Medicines & Healthcare Products Regulatory Agency	215964, 215984, 392920, 392922
HK	Department of Health Drug Office	61968, 61969
IE	Health Products Regulatory Authority	88783, 88784
IL	מִשְׂרַד הַבְּרִיאוּת	6927, 6928
IT	Agenzia del Farmaco	042549016, 042549028, 042549030, 042549042
JP	医薬品医療機器総合機構	4291026M1023, 4291026M2020
LT	Valstybinė vaistų kontrolės tarnyba	1068261, 1068262, 1068263, 1068264
NL	Z-Index G-Standaard, PRK	104507, 104515
NZ	Medicines and Medical Devices Safety Authority	16912, 16913
PL	Rejestru Produktów Leczniczych	100285117, 100285146
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64866001, W64867001
SG	Health Sciences Authority	14247P, 14248P
TN	Direction de la Pharmacie et du Médicament	20473021H, 20473022H
TR	İlaç ve Tıbbi Cihaz Kurumu	8681308159151, 8681308159168
US	FDA, National Drug Code	0069-8140, 0069-8141
ZA	Health Products Regulatory Authority	47/26/0568, 47/26/0569