IMBRUVICA

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

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 about Ibrutinib

Medication package inserts

Below package inserts are available for further reading:

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