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.
-
List item
Bosulif : EPAR - Medicine overview (PDF/80.44 KB)
First published: 09/04/2013
Last updated: 24/05/2018
EMA/42251/2013 -
-
List item
Bosulif : EPAR - Risk-management-plan summary (PDF/214.48 KB)
First published: 07/05/2018
Last updated: 28/11/2018
Authorisation details
Product details | |
---|---|
Name |
Bosulif
|
Agency product number |
EMEA/H/C/002373
|
Active substance |
bosutinib (as monohydrate)
|
International non-proprietary name (INN) or common name |
bosutinib
|
Therapeutic area (MeSH) |
Leukemia, Myeloid
|
Anatomical therapeutic chemical (ATC) code |
L01XE14
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Conditional approval |
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. |
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
27/03/2013
|
Contact address |
Product information
13/11/2019 Bosulif - EMEA/H/C/002373 - N/0040
Contents
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
-
Antineoplastic agents
-
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.