ICLUSIG

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, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, UK.

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 more about Ponatinib

Medication package inserts

Below package inserts are available for further reading:

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