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Regadenoson

Rapiscan

Extended indication Extension of Indication to include use in the measurement of fractional flow reserve (FFR) during in
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Regadenoson
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Extended indication Extension of Indication to include use in the measurement of fractional flow reserve (FFR) during invasive coronary angiography (ICA) in patients presenting a coronary artery stenosis.
Proprietary name Rapiscan
Manufacturer GE
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Adenosine A2 receptor agonists

Registration

Registration route Centralised (EMA)
Submission date 2018
Expected Registration February 2019
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options adenosine
Therapeutic value No judgement
Substantiation Geen meerwaarde verwacht, wellicht alleen een effect te verwachten op minder pulmonale bijwerkingen.
Duration of treatment one-off
Dosage per administration 400 microgram
References Inschatting dosering gebaseerd op huidige EPAR.

Expected patient volume per year

Additional remarks In de praktijk weinig patiënten verwacht.

Expected cost per patient per year

Additional remarks Regadenoson injectievloeistof 80UG/ML FL 5ML, 1 injectieflacon € 74,09, dit product is echter niet vergoed in Nederland.

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.