IBRANCE

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Tunisia, UK, 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 more about Palbociclib

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
B4-9327	Capsule	Ibrance 125 mg Capsules CAP 125 mg 1 x 21's (in HDPE bottle)	Hard Capsule. Opaque, hard capsule, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white). The capsule length is 21.7 ± 0.3 mm	31/07/2024
B4-9328	Capsule	Ibrance 100 mg Capsules CAP 100 mg 1 x 21's (in HDPE bottle)	Hard Capsule. Opaque, hard capsule, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white). The capsule length is 19.4 ± 0.3 mm	31/07/2024
B4-9329	Capsule	Ibrance 75 mg Capsules CAP 75 mg 1 x 21's (in HDPE bottle)	Hard Capsule. Opaque, hard capsule, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white). The capsule length is 18.0 ± 0.3 mm	31/07/2024

Medication package inserts

Below package inserts are available for further reading:

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