Extended indication Extension of indication to include treatment of the paediatric population for Lonquex and introduction of an age appropriate presentation in vials.
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Lipegfilgrastim
Domain Oncology and Hematology
Reason of inclusion Indication extension IND
Main indication Oncology other
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 Unknown
Therapeutical formulation Unknown
Budgetting framework Intermural (MSZ)
Additional remarks Granulocyte stimulant, haematopoiesis stimulant en neutrophil stimulant.

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Submission date August 2020
Expected Registration June 2021
Orphan drug Unknown
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

References medicijnkosten.nl
Additional remarks LONQUEX, 0,6 ml INJECTIEVLOEISTOF 10MG/ML € 1.024,05.

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information