IMBRUVICA

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 IMBRUVICA contains one active pharmaceutical ingredient (API):

1	Ibrutinib UNII 1X70OSD4VX - IBRUTINIB
	Ibrutinib is a potent, small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). BTK, a member of the Tec kinase family, is an important signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. Preclinical studies have shown that ibrutinib effectively inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.
	Read more about Ibrutinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
IMBRUVICA 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
L01EL01		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EL Bruton's tyrosine kinase (BTK) inhibitors
Discover more medicines within L01EL01

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	11213E, 11419B
BR	Câmara de Regulação do Mercado de Medicamentos	514515110028201, 514515110028301
CA	Health Products and Food Branch	02434407
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1262-MEE-0815, 4917-MEE-0120, 6353-MEE-0621, 6359-MEE-0621, 6362-MEE-0621, 6366-MEE-0621
EE	Ravimiamet	1668034, 1668045, 1775134, 1775145, 1775156, 1775167, 1798814, 1798825, 1798836, 1798847, 1798858, 1798869
ES	Centro de información online de medicamentos de la AEMPS	114945001, 114945002, 114945005, 114945006, 114945008, 114945010
FI	Lääkealan turvallisuus- ja kehittämiskeskus	026692, 184046, 410223, 420639, 459405, 561239
FR	Base de données publique des médicaments	63012197, 64209404, 66940571, 67351558, 69196284
GB	Medicines & Healthcare Products Regulatory Agency	374924, 374927, 374930, 374933
HK	Department of Health Drug Office	64088, 65397, 67062, 67063
IE	Health Products Regulatory Authority	88597, 88835, 88836, 88837, 88838
IL	מִשְׂרַד הַבְּרִיאוּת	7394, 7487, 9153, 9154, 9155, 9157
IT	Agenzia del Farmaco	043693011, 043693023, 043693035, 043693047, 043693050, 043693062, 043693074, 043693086, 043693098, 043693100, 043693112, 043693124
JP	医薬品医療機器総合機構	4291043M1027
LT	Valstybinė vaistų kontrolės tarnyba	1074723, 1074724, 1086093, 1086094, 1087679, 1087680, 1087681, 1087682, 1087683, 1087684
NL	Z-Index G-Standaard, PRK	120960, 200530, 200549, 200565, 200573
NZ	Medicines and Medical Devices Safety Authority	17325, 20296, 20336, 20337, 20338
PL	Rejestru Produktów Leczniczych	100327407, 100417760, 100417777, 100417783, 100417808
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W61749001, W61749002, W66231001, W66232001, W66233001, W66234001
SG	Health Sciences Authority	14819P
TN	Direction de la Pharmacie et du Médicament	15273031H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593095580, 8699593095597, 8699593095603, 8699593095610, 8699593151224, 8699593151255
US	FDA, National Drug Code	57962-007, 57962-014, 57962-070, 57962-140, 57962-280, 57962-420, 57962-560
ZA	Health Products Regulatory Authority	50/26/0939, 55/26/0297, 55/26/0298, 55/26/0299, 55/26/0300