Bosulif has been authorised under a conditional approval scheme. The European Medicines Agency will review new information on this medicine at least every year and update the SmPC as necessary.
What is BOSULIF and what is it used for?1
BOSULIF belongs to a group of medicines that target cancer cells. These medicines are called antineoplastic agents. BOSULIF contains the active substance bosutinib.
It is used to treat adult patients who have a type of leukaemia called Philadelphia chromosome-positive (Ph-positive) Chronic Myeloid Leukaemia (CML) and are newly-diagnosed or for whom previous medicines to treat CML have either not worked or are not suitable. Ph-positive CML is a cancer of the blood which makes the body produce too many of a specific type of white blood cell called granulocytes.
If you have any questions about how BOSULIF works or why this medicine has been prescribed for you, ask your doctor.
BOSULIF is available as tablets (100, 400 and 500 mg) and the medicine can only be obtained with a prescription.
The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. One of the ways they do this is by producing evidence-based guidance. See NICE guidance on BOSULIF
The Scottish Medicines Consortium is the national source of advice on the clinical and cost-effectiveness of all new medicines for NHS Scotland. Their aim is to ensure that people in Scotland have timely access to medicines that provide most benefit based on best available evidence. See SMC guidance on BOSULIF
The European Medicines Agency (EMA) is an agency of the European Union (EU). The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. See EMA guidance on BOSULIF
Medicines in Northern Ireland fall under the remit of the European Medicines Agency (EMA) whilst medicines in Great Britain (England, Scotland and Wales) fall under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA) since Brexit. These agencies are responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies.
If you would like to see the Summary of Product Characteristics (SPC) or Patient Information Leaflet (PIL) for BOSULIF please follow these links:
- BOSULIF Great Britain Patient Information Leaflet, BOSULIF Northern Ireland Patient Information Leaflet. January 2022
PP-BOS-GBR-1454 / January 2022