Bosulif

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bosutinib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 10/08/2018

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
16
Date of issue of marketing authorisation valid throughout the European Union
26/03/2013
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

02/08/2018 Bosulif - EMEA/H/C/002373 - T/0032

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.

Assessment history

Changes since initial authorisation of medicine

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