Extended indication Extension of indication to include treatment of the paediatric population for Lonquex and introducti
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Lipegfilgrastim
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Other oncology
Extended indication Extension of indication to include treatment of the paediatric population for Lonquex and introduction of an age appropriate presentation in vials.
Proprietary name Lonquex
Manufacturer Teva
Mechanism of action Other, see general comments
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Granulocyte stimulant, haematopoiesis stimulant en neutrophil stimulant.

Registration

Registration route Centralised (EMA)
Submission date August 2020
Expected Registration June 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

Patient volume

< 600

Market share is generally not included unless otherwise stated.

Additional comments Er zijn ongeveer 600 kinderen per jaar die gediagnosticeerd worden. Hiervan zal een gedeelte mogelijk behandeld worden.

Expected cost per patient per year

References medicijnkosten.nl
Additional comments Lonquex, 0,6 ml injectievloeistof 10mg/ml €1.024,05.

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.