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Questions & Answers

On 22 February 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bosulif. The marketing authorisation holder for this medicinal product is Pfizer Limited.

The CHMP adopted an extension to the existing indication for Bosulif as follows1:

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

1 New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Bosulif (English only) 2018-02-23  

Key facts

Product details for Bosulif
INN or common name


Therapeutic area Leukemia, Myeloid
Active substance

bosutinib (as monohydrate)

Date opinion adopted22/02/2018
Company name

Pfizer Limited

Application typePost authorisation