United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - bosutinib - tablet - 100mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - bosutinib - tablet - 500mg

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - bosutinib (as monohydrate) - leukemia, myeloid - antineoplastic agents, protein kinase inhibitors - 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.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - bosutinib as monohydrate - film coated tablets - bosutinib as monohydrate 100 mg - bosutinib - bosulif is indicated for the treatment of adult patients with:• newly diagnosed chronic phase (cp) philadelphia chromosome-positive chronic myelogenous leukaemia (ph+ cml).• chronic phase (cp), accelerated phase (ap), and blast phase (bp) philadelphia chromosome positive chronic myelogenous leukaemia (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.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - bosutinib as monohydrate - film coated tablets - bosutinib as monohydrate 500 mg - bosutinib - bosulif is indicated for the treatment of adult patients with:• newly diagnosed chronic phase (cp) philadelphia chromosome-positive chronic myelogenous leukaemia (ph+ cml).• chronic phase (cp), accelerated phase (ap), and blast phase (bp) philadelphia chromosome positive chronic myelogenous leukaemia (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.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - bosutinib as monohydrate - film coated tablets - bosutinib as monohydrate 400 mg - bosutinib - 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.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

pfizer europe ma eeig, belgium - bosutinib - film-coated tablet - 100 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

jazeera pharmaceutical industries (jpi), saudi arabia - bosutinib - film-coated tablet - 500 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

jazeera pharmaceutical industries (jpi), saudi arabia - bosutinib - film-coated tablet - 100 mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة أدوية الحكمة - hikma pharmaceuticals - bosutinib (as bosutinib monohydrate) 500 mg/1 tab - 500 mg/1 tab