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BOSULIF Film-coated tablet (2019)

Active ingredients: Bosutinib

Product Name and Form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
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)
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)

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 27 March 2013

Date of latest renewal: 18 February 2019

Marketing authorization number:

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