Active ingredients: Bosutinib
Bosulif 100 mg film-coated tablets.
Bosulif 400 mg film-coated tablets.
Bosulif 500 mg film-coated tablets.
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.
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.
Tablet core:
Microcrystalline cellulose (E460)
Croscarmellose sodium (E468)
Poloxamer 188
Povidone (E1201)
Magnesium stearate (E470b)
Film coating:
Bosulif 100 mg film-coated tablets:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc (E553b)
Iron oxide yellow (E172)
Bosulif 400 mg film-coated tablets:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc (E553b)
Iron oxide yellow (E172)
Iron oxide red (E172)
Bosulif 500 mg film-coated tablets:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc (E553b)
Iron oxide red (E172)
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