Bosulif is a cancer medicine that is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in adults with a special chromosome in their cells called the Philadelphia chromosome.
It is used to treat three stages of CML called ‘chronic phase’, ‘accelerated phase’ and ‘blast phase’ in patients who have already been treated with one or more tyrosine kinase inhibitors (medicines for CML which work in a similar way to Bosulif), and when the tyrosine kinase inhibitors called dasatinib, imatinib and nilotinib are not suitable.
Bosulif is also used to treat newly diagnosed patients who are in the ‘chronic phase’ of CML.
Bosulif contains the active substance bosutinib.
Bosulif : EPAR - Medicine overview (PDF/109.8 KB)
First published: 09/04/2013
Last updated: 09/06/2022
Bosulif : EPAR - Risk-management-plan summary (PDF/85.89 KB)
First published: 07/05/2018
Last updated: 03/05/2022
|Agency product number||
bosutinib (as monohydrate)
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
Boulevard de la Plaine 17
07/04/2022 Bosulif - EMEA/H/C/002373 - II/0050/G
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Protein kinase inhibitors
Bosulif is indicated for the treatment of adult patients with:
- newly‑diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
- CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.