Bosulif (bosutinib)
- Region
- 🇪🇺 EU
- Active substance
- bosutinib
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid
- CHMP opinion
- Thu 17 Jan 2013
- EU approval
- Wed 27 Mar 2013
- Application
- EMEA/H/C/002373
- ATC
- L01EA04
- Official record
- www.ema.europa.eu
Indication
Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• Adult and paediatric patients aged 6 years and older with CP 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.• Adult patients with 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.
Regulatory milestones
No milestones recorded in the last year.
Follow Bosulif
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.