SPRYCEL

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

Active ingredients

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

1	Dasatinib UNII RBZ1571X5H - DASATINIB
	Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected oncogenic kinases including c-KIT, ephrin (EPH) receptor kinases, and PDGFβ receptor. Dasatinib is a potent, subnanomolar inhibitor of the BCR-ABL kinase with potency at concentration of 0.6-0.8 nM. It binds to both the inactive and active conformations of the BCR-ABL enzyme.
	Read more about Dasatinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SPRYCEL Film-coated tablet	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
L01EA02	Dasatinib	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EA BCR-ABL tyrosine kinase inhibitors
Discover more medicines within L01EA02

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	1354G, 1381Q, 1415L, 1416M, 2478K, 2482P, 2485T, 9125G, 9126H, 9127J, 9342Q, 9343R
BR	Câmara de Regulação do Mercado de Medicamentos	505107801119218, 505107802115216, 505112050017802
CA	Health Products and Food Branch	02293129, 02293137, 02293145, 02320193, 02360810, 02360829
EE	Ravimiamet	1275735, 1275746, 1275757, 1275768, 1275779, 1275780, 1481767, 1496831, 1496864, 1775190
ES	Centro de información online de medicamentos de la AEMPS	06363004, 06363005, 06363006
FI	Lääkealan turvallisuus- ja kehittämiskeskus	052223, 052251, 052278
FR	Base de données publique des médicaments	60249903, 61505362, 61641704, 61892368, 63212461, 69381411
GB	Medicines & Healthcare Products Regulatory Agency	154065, 164969, 164971, 184314, 184317, 372220
HK	Department of Health Drug Office	55803, 55804, 55805
IE	Health Products Regulatory Authority	88549, 88577, 88578, 88579
IL	מִשְׂרַד הַבְּרִיאוּת	6377, 6378, 6379, 6627
JP	医薬品医療機器総合機構	4291020F1027, 4291020F2023
LT	Valstybinė vaistų kontrolės tarnyba	1030848, 1030849, 1030850, 1030851, 1030852, 1030853, 1036525, 1036526, 1056804, 1056805, 1056806, 1056807, 1076380, 1076381, 1087480
NL	Z-Index G-Standaard, PRK	197580, 82112, 82120, 82139, 88773
NZ	Medicines and Medical Devices Safety Authority	12512, 12513, 12514, 13871
PL	Rejestru Produktów Leczniczych	100138787, 100140034, 100141430, 100201497, 100235987, 100235993, 100408896
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65561001, W65561002, W65561003, W65562001, W65562002, W65562003, W65563001, W65563002, W65563003, W65564001, W65564003
SG	Health Sciences Authority	13352P, 13353P, 13354P
TN	Direction de la Pharmacie et du Médicament	1673021H, 1673022H, 1673023H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699726094206, 8699726094404, 8699726094602, 8699726094800
US	FDA, National Drug Code	0003-0524, 0003-0527, 0003-0528, 0003-0852, 0003-0855, 0003-0857
ZA	Health Products Regulatory Authority	41/26/1039, 41/26/1040, 41/26/1041, 44/26/0205