Source: European Medicines Agency (EU) Revision Year: 2019 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.
| 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. |
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).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Bosutinib |
Bosutinib belongs to a pharmacological class of medicinal products known as kinase inhibitors. Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML. Modeling 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. In in vitro studies, bosutinib inhibits proliferation and survival of established CML cell lines, Ph+ ALL cell lines, and patient-derived primary primitive CML cells. |
| 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 |
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.
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
Date of first authorisation: 27 March 2013
Date of latest renewal: 18 February 2019
| 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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