KISQALI

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, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Tunisia, UK.

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 more about Ribociclib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
KISQALI 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
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)
AU	Pharmaceutical Benefits Scheme	11385F, 11386G, 11397W
BR	Câmara de Regulação do Mercado de Medicamentos	526518100094202, 526518100094302, 526518100094402
CA	Health Products and Food Branch	02473569
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	4538-MEE-0119
EE	Ravimiamet	1752397, 1752409, 1752410, 1752421, 1752432
ES	Centro de información online de medicamentos de la AEMPS	1171221001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	107785, 183485, 539793
FR	Base de données publique des médicaments	68343525
GB	Medicines & Healthcare Products Regulatory Agency	348146, 348147, 348148, 383756
HK	Department of Health Drug Office	65561
IE	Health Products Regulatory Authority	88847, 88848
IL	מִשְׂרַד הַבְּרִיאוּת	8115, 8116
IT	Agenzia del Farmaco	045618016, 045618028, 045618030, 045618042, 045618055, 045618067, 045618079, 045618081, 045618093, 045618105, 045618117, 045618129, 049707019
LT	Valstybinė vaistų kontrolės tarnyba	1083751, 1083752, 1083753, 1083754, 1083755, 1083756, 1083757, 1083758, 1083759, 1083760, 1083761, 1083762
NL	Z-Index G-Standaard, PRK	147516
NZ	Medicines and Medical Devices Safety Authority	20066
PL	Rejestru Produktów Leczniczych	100390647
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64450001, W64450002, W64450003, W64450004
SG	Health Sciences Authority	15407P
TN	Direction de la Pharmacie et du Médicament	10283401H
US	FDA, National Drug Code	0078-0860, 0078-0867, 0078-0874