Bosulif
bosutinib
Table of contents
Overview
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.
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List item
Bosulif : EPAR - Medicine overview (PDF/109.8 KB)
First published: 09/04/2013
Last updated: 09/06/2022
EMA/318082/2022 -
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List item
Bosulif : EPAR - Risk-management-plan summary (PDF/85.89 KB)
First published: 07/05/2018
Last updated: 03/05/2022
Authorisation details
Product details | |
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Name |
Bosulif
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Agency product number |
EMEA/H/C/002373
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Active substance |
bosutinib (as monohydrate)
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International non-proprietary name (INN) or common name |
bosutinib
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Therapeutic area (MeSH) |
Leukemia, Myeloid
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Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
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Revision |
24
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Date of issue of marketing authorisation valid throughout the European Union |
27/03/2013
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Contact address |
Boulevard de la Plaine 17 |
Product information
16/05/2023 Bosulif - EMEA/H/C/002373 - IAIN/0056
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
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Antineoplastic agents
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Protein kinase inhibitors
Therapeutic indication
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.