BOSULIF

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Spain, Turkey, UK.

Active ingredients

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

1
UNII 844ZJE6I55 - BOSUTINIB MONOHYDRATE
 

Bosutinib belongs to a pharmacological class of medicinal products known as kinase inhibitors. Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML. Modeling studies indicate that bosutinib binds the kinase domain of BCR-ABL. Bosutinib is also an inhibitor of Src family kinases including Src, Lyn and Hck. Bosutinib minimally inhibits platelet-derived growth factor (PDGF) receptor and c-Kit. In in vitro studies, bosutinib inhibits proliferation and survival of established CML cell lines, Ph+ ALL cell lines, and patient-derived primary primitive CML cells.

 
Read more about Bosutinib

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 BOSULIF 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
L01EA04 Bosutinib L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EA BCR-ABL tyrosine kinase inhibitors
Discover more medicines within L01EA04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
CA Health Products and Food Branch 02419149, 02419157
EE Ravimiamet 1612055, 1612066, 1612077, 1612088, 1665468, 1773121, 1773132
ES Centro de información online de medicamentos de la AEMPS 113818001, 113818003, 113818006
FI Lääkealan turvallisuus- ja kehittämiskeskus 479904, 492377, 558417
FR Base de données publique des médicaments 60462965, 61669899, 63150294
GB Medicines & Healthcare Products Regulatory Agency 226977, 226980, 355976
IE Health Products Regulatory Authority 88032, 88107
IL מִשְׂרַד הַבְּרִיאוּת 7661, 7662, 8714
JP 医薬品医療機器総合機構 4291036F1028
LT Valstybinė vaistų kontrolės tarnyba 1069897, 1069898, 1069899, 1069900, 1074112, 1088046, 1088047
NL Z-Index G-Standaard, PRK 106070, 106089, 151041
PL Rejestru Produktów Leczniczych 100297089, 100297095, 100417145
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W64815001, W64816001, W67871001
TR İlaç ve Tıbbi Cihaz Kurumu 8681308097446, 8681308097453, 8681308097613, 8681308097620, 8681308097637
US FDA, National Drug Code 0069-0135, 0069-0136, 0069-0193, 63539-117

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