Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 08 May 2018

Indication(s)

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.

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More information

Category Value
Agency product number EMEA/H/C/002373
Orphan designation Yes
Date First Approved 27-03-2013
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Pfizer Ltd
Warnings

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reacti