Extended indication Treatment of angiofibroma associated with tuberous sclerosis complex
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Sirolimus
Domain Oncology
Reason of inclusion Indication extension
Extended indication Treatment of angiofibroma associated with tuberous sclerosis complex
Proprietary name Rapamune
Manufacturer Merck
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments mTOR remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2021
Expected Registration September 2022
Orphan drug Yes
Registration phase Registration application pending

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

References Medicijnkosten
Additional comments Gemiddelde prijs per verpakking €433,34. Behandelduur en dosering nog niet bekend.

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.