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Angiotensin II

Giapreza

Extended indication Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other dis
Therapeutic value No judgement
Registration phase Registered

Product

Active substance Angiotensin II
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies.
Proprietary name Giapreza
Manufacturer La Jolla
Mechanism of action Receptor agonist
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Angiotensin-type-1-receptor-agonists

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2018
Expected Registration August 2019
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie in juni 2019. Geregistreerd per 23/08/2019.

Therapeutic value

Therapeutic value No judgement
Substantiation De inschatting is dat dit geneesmiddel niet veel gebruikt gaat worden in Nederland.
Dosage per administration starten met 20 ng/ kg/min voor 3 uur

Expected patient volume per year

References SPS
Additional remarks In de V.S. 300.000 personen die in aanmerking zouden komen voor het geneesmiddel, teruggerekend naar Nederland zou dat gaan 15.000 patiënten. Echter, gezien de verwachting van de werkgroep dat dit geneesmiddel niet veel gebruikt gaat worden in Nederland zal het aantal patiënten beperkt blijven.

Expected cost per patient per year

Cost 1,400.00
References https://www.drugs.com/price-guide/giapreza; EPAR
Additional remarks Een flacon Giapreza 2,5 mg/ml kost in de VS $1.576 (~€1.400). Een flacon is voldoende voor 1 dosis.

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.