Romiplostim

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.
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 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	No judgement

There is currently nothing known about the expected patient volume.

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

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.