IBRANCE Hard capsule Ref.[9143] Active ingredients: Palbociclib

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Product name and form

IBRANCE 75 mg hard capsules.

IBRANCE 100 mg hard capsules.

IBRANCE 125 mg hard capsules.

Pharmaceutical Form

Hard capsule.

IBRANCE 75 mg hard capsules: 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.

IBRANCE 100 mg hard capsules: 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.

IBRANCE 125 mg hard capsules: 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.

Qualitative and quantitative composition

IBRANCE 75 mg hard capsules

Each hard capsule contains 75 mg of palbociclib.

Excipients with known effect: Each hard capsule contains 56 mg of lactose (as monohydrate).

IBRANCE 100 mg hard capsules

Each hard capsule contains 100 mg of palbociclib.

Excipients with known effect: Each hard capsule contains 74 mg of lactose (as monohydrate).

IBRANCE 125 mg hard capsules

Each hard capsule contains 125 mg of palbociclib.

Excipients with known effect: Each hard capsule contains 93 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
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.

List of Excipients

Capsule content:

Microcrystalline cellulose
Lactose monohydrate
Sodium starch glycolate type A
Colloidal anhydrous silica
Magnesium stearate

Capsule shell:

Gelatin
Red iron oxide (E172)
Yellow iron oxide (E172)
Titanium dioxide (E171)

Printing ink:

Shellac
Titanium dioxide (E171)
Ammonium hydroxide (28% solution)
Propylene glycol
Simeticone

Pack sizes and marketing

PVC/PCTFE/PVC/Al blister strip containing 7 hard capsules (one capsule per cell). Each carton contains 21 hard capsules (3 blister strips per pack) or 63 hard capsules (9 blister strips per pack).

HDPE bottle with a PP closure containing 21 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Marketing authorization dates and numbers

IBRANCE 75 mg hard capsules:

EU/1/16/1147/001
EU/1/16/1147/002
EU/1/16/1147/007

IBRANCE 100 mg hard capsules:

EU/1/16/1147/003
EU/1/16/1147/004
EU/1/16/1147/008

IBRANCE 125 mg hard capsules:

EU/1/16/1147/005
EU/1/16/1147/006
EU/1/16/1147/009

Date of first authorisation: 09 November 2016
Date of latest renewal: 16 July 2021

Drugs

Drug Countries
IBRANCE Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States

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