Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
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. |
Each hard capsule contains 75 mg of palbociclib.
Excipients with known effect: Each hard capsule contains 56 mg of lactose (as monohydrate).
Each hard capsule contains 100 mg of palbociclib.
Excipients with known effect: Each hard capsule contains 74 mg of lactose (as monohydrate).
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 Capsule shell: Gelatin Printing ink: Shellac |
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.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
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
| Drug | Countries | |
|---|---|---|
| IBRANCE | 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 |
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