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Bosutinib

Bosulif

Extended indication Extension of indication to include treatment of paediatric patients greater than or equal to 1 year
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Bosutinib
Domain Hematology
Reason of inclusion Indication extension
Main indication CML
Extended indication Extension of indication to include treatment of paediatric patients greater than or equal to 1 year of age with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML)
Proprietary name Bosulif
Manufacturer Pfizer
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Tweede generatie Tyrosinekinaseremmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2024
Expected Registration December 2024
Orphan drug No
Registration phase Registration application pending
Additional remarks NCT04258943

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.