IBRANCE

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

Active ingredients

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

1 Palbociclib UNII G9ZF61LE7G - PALBOCICLIB

Palbociclib is a highly selective, reversible inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Through inhibition of CDK4/6, palbociclib reduced cellular proliferation by blocking progression of the cell from G1 into S phase of the cell cycle. Testing of palbociclib in a panel of molecularly profiled breast cancer cell lines revealed high activity against luminal breast cancers, particularly ER-positive breast cancers. Read about Palbociclib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
IBRANCE 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
L01EF01		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EF Cyclin-dependent kinase (CDK) inhibitors
Discover more medicines within L01EF01

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): 11698Q, 11699R, 11700T
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 522720050087317, 522720050087417, 522720050087517
Country: CA	Health Products and Food Branch	Identifier(s): 02453150, 02453169, 02453177, 02493535, 02493543, 02493551
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 3268-MEE-0618, 3269-MEE-0618, 3270-MEE-0618, 6967-MEE-0222, 7035-MEE-0222, 7040-MEE-0222
Country: EE	Ravimiamet	Identifier(s): 1731967, 1731978, 1731989, 1777776, 1777787, 1777800, 1811528, 1811539, 1811540, 1811551, 1811562, 1811573
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1161147001, 1161147003, 1161147005
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 177199, 374450, 399825, 477864, 523284, 566929
Country: FR	Base de données publique des médicaments	Identifier(s): 60321676, 67316379, 68016146
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 369442, 369446, 369449, 392723, 392726, 392744, 392745, 392753, 392756
Country: HK	Department of Health Drug Office	Identifier(s): 64836, 64837, 64838, 66989, 66990, 66991
Country: IE	Health Products Regulatory Authority	Identifier(s): 88896, 88897, 88898
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7906, 7907, 7908
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291051F1022, 4291051F2029, 4291051M1021, 4291051M2028
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1081626, 1081627, 1081628, 1081629, 1081630, 1081631, 1085336, 1085337, 1085338, 1089436, 1089437, 1089438, 1089439, 1089440, 1089441
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 251M2016
Country: NG	Registered Drug Product Database	Identifier(s): B4-9327, B4-9328, B4-9329
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 139459, 139467, 139475
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 17671, 18686, 18687, 21766, 21767, 21768
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100379982, 100379999, 100380005, 100442195, 100442203, 100442210
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64762001, W64763001, W64764001, W66539001, W66544001, W66548001
Country: SG	Health Sciences Authority	Identifier(s): 15048P, 15049P, 15050P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 14943011H, 14943012H, 14943013H
Country: US	FDA, National Drug Code	Identifier(s): 0069-0187, 0069-0188, 0069-0189, 0069-0284, 0069-0486, 0069-0688, 63539-187, 63539-188, 63539-189, 63539-284, 63539-486, 63539-688