KISQALI

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

Active ingredients

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

1 Ribociclib
UNII BG7HLX2919 - RIBOCICLIB SUCCINATE

Ribociclib is a selective inhibitor of cyclin-dependent kinase (CDK) 4 and 6, resulting in 50% inhibition (IC50) values of 0.01 (4.3 ng/ml) and 0.039 μM (16.9 ng/ml) in biochemical assays, respectively. These kinases are activated upon binding to D-cyclins and play a crucial role in signalling pathways which lead to cell cycle progression and cellular proliferation.

Read about Ribociclib

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
KISQALI Film-coated tablet 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
L01EF02 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EF Cyclin-dependent kinase (CDK) inhibitors
Discover more medicines within L01EF02

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): 11385F, 11386G, 11397W
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 526518100094202, 526518100094302, 526518100094402
Country: CA Health Products and Food Branch Identifier(s): 02473569
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 4538-MEE-0119
Country: EE Ravimiamet Identifier(s): 1752397, 1752409, 1752410, 1752421, 1752432
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 1171221001
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 107785, 183485, 539793
Country: FR Base de données publique des médicaments Identifier(s): 68343525
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 348146, 348147, 348148, 383756
Country: HK Department of Health Drug Office Identifier(s): 65561
Country: IE Health Products Regulatory Authority Identifier(s): 88847, 88848
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 8115, 8116
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1083751, 1083752, 1083753, 1083754, 1083755, 1083756, 1083757, 1083758, 1083759, 1083760, 1083761, 1083762
Country: NL Z-Index G-Standaard, PRK Identifier(s): 147516
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 20066
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100390647
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W64450001, W64450002, W64450003, W64450004
Country: SG Health Sciences Authority Identifier(s): 15407P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 10283401H
Country: US FDA, National Drug Code Identifier(s): 0078-0860, 0078-0867, 0078-0874

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