SPRYCEL

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, 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 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 about Dasatinib

Medication package inserts

Below package inserts are available for further reading:

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