ICLUSIG

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

Active ingredients

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

1 Ponatinib UNII 96R6PU3D8J - PONATINIB HYDROCHLORIDE

Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triple-bond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase. Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL with IC50 values of 0.4 and 2.0 nM, respectively. Read about Ponatinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ICLUSIG Film-coated tablets	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
L01EA05		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EA BCR-ABL tyrosine kinase inhibitors
Discover more medicines within L01EA05

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): 10520Q, 10523W, 10524X, 10530F, 11453T, 11454W
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 576120010000107, 576120010000207
Country: CA	Health Products and Food Branch	Identifier(s): 02437333, 02437341
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 5326-MEE-0720
Country: EE	Ravimiamet	Identifier(s): 1619669, 1619670, 1619681, 1619692, 1697621, 1706228, 1847662, 1849743
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113839003, 113839005, 113839006
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 137460, 399211, 465337, 526595
Country: FR	Base de données publique des médicaments	Identifier(s): 63894229, 63898099, 64793382
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 235831, 347938, 347941
Country: HK	Department of Health Drug Office	Identifier(s): 66051, 66052
Country: IE	Health Products Regulatory Authority	Identifier(s): 88674, 88865, 88866
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7656, 7657, 8451
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291048F1020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1070758, 1070759, 1070760, 1070761, 1079163, 1079693
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 106747, 107581, 136301
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100310594, 100310602, 100383340
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64971001, W64971002, W64971003, W64972001, W64973001, W64973002
Country: SG	Health Sciences Authority	Identifier(s): 15581P, 15582P
Country: US	FDA, National Drug Code	Identifier(s): 63020-533, 63020-534, 63020-535