Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Bosulif 100 mg film-coated tablets.
Bosulif 400 mg film-coated tablets.
Bosulif 500 mg film-coated tablets.
Bosulif 50 mg hard capsules.
Bosulif 100 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Bosulif 100 mg film-coated tablets: Yellow oval (width: 5.6 mm; length: 10.7 mm) biconvex, film-coated tablet debossed with "Pfizer" on one side and "100" on the other side. Bosulif 400 mg film-coated tablets: Orange oval (width: 8.8 mm; length: 16.9 mm) biconvex, film-coated tablet debossed with "Pfizer" on one side and "400" on the other side. Bosulif 500 mg film-coated tablets: Red oval (width: 9.5 mm; length: 18.3 mm) biconvex, film-coated tablet debossed with "Pfizer" on one side and "500" on the other side. Hard capsule. Bosulif 50 mg hard capsules: White body/orange cap (approximate length: 18 mm) with "BOS 50" printed on the body and "Pfizer" printed on the cap in black ink. Bosulif 100 mg hard capsules: White body/brownish-red cap (approximate length: 22 mm) with "BOS 100" printed on the body and "Pfizer" printed on the cap in black ink. |
Bosulif 100 mg film-coated tablets: Each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Bosulif 400 mg film-coated tablets: Each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Bosulif 500 mg film-coated tablets: Each film-coated tablet contains 500 mg bosutinib (as monohydrate).
Bosulif 50 mg hard capsules: Each hard capsule contains 50 mg bosutinib (as monohydrate).
Bosulif 100 mg hard capsules: Each hard capsule contains 100 mg bosutinib (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Bosutinib belongs to a pharmacological class of medicinal products known as kinase inhibitors. Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML. Modelling studies indicate that bosutinib binds the kinase domain of BCR-ABL. Bosutinib is also an inhibitor of Src family kinases including Src, Lyn and Hck. Bosutinib minimally inhibits platelet-derived growth factor (PDGF) receptor and c-Kit. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Film coating: Bosulif 100 mg film-coated tablets Polyvinyl alcohol Bosulif 400 mg film-coated tablets Polyvinyl alcohol Bosulif 500 mg film-coated tablets Polyvinyl alcohol Bosulif hard capsules: Mannitol (E421) Bosulif hard capsule shells Gelatin Printing ink hard capsules Shellac (E904) |
White opaque 3-ply PVC/Polychlorotrifluoroethene/PVC blister sealed with push-through foil backing containing either 14 or 15 tablets.
Bosulif 100 mg film-coated tablets: Each carton contains 28, 30 or 112 tablets.
Bosulif 400 mg film-coated tablets: Each carton contains 28 or 30 tablets.
Bosulif 500 mg film-coated tablets: Each carton contains 28 or 30 tablets.
High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal (HIS).
Bosulif 50 mg hard capsules: Cartons of one bottle containing 30 hard capsules.
Bosulif 100 mg hard capsules: Cartons of one bottle containing 150 hard capsules.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Bosulif 100 mg film-coated tablets:
EU/1/13/818/001
EU/1/13/818/002
EU/1/13/818/005
Bosulif 400 mg film-coated tablets:
EU/1/13/818/006
EU/1/13/818/007
Bosulif 500 mg film-coated tablets:
EU/1/13/818/003
EU/1/13/818/004
Bosulif 50 mg hard capsules:
EU/1/13/818/008
Bosulif 100 mg hard capsules:
EU/1/13/818/009
Date of first authorisation: 27 March 2013
Date of latest renewal: 31 March 2022
| Drug | Countries | |
|---|---|---|
| BOSULIF | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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