Extended indication Extension of indication to add the use of romiplostim in adult patients who have had idiopathic thro
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Romiplostim
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other non-oncological hematological medications
Extended indication Extension of indication to add the use of romiplostim in adult patients who have had idiopathic thrombocytopenic purpura (ITP) for ≤ 12 months and who have had an insufficient response to corticosteroids or immunoglobulins.
Proprietary name Nplate
Manufacturer Amgen
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2020
Expected Registration April 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

References medicijnkosten.nl
Additional comments Gemiddelde prijs per 1 injectieflacon NPLATE, 125 μg POEDER VOOR INJECTIEVLOEISTOF 125UG € 393,61

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.