An overview of Bosulif and why it is authorised in the EU
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/80.44 KB)
First published: 09/04/2013
Last updated: 24/05/2018
Bosulif : EPAR - Risk-management-plan summary (PDF/1.49 MB)
First published: 07/05/2018
Last updated: 07/05/2018
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bosutinib (as monohydrate)
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
02/08/2018 Bosulif - EMEA/H/C/002373 - T/0032
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.