Extended indication Hypotension in adults with septic or other distributive shock
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Angiotensin II
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Hypotension in adults with septic or other distributive shock
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 Registration application pending
Additional remarks In Juli op de lijst van de EMA (Medicines Under Evaluation).

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

Patient volume

< 15,000

Market share is generally not included unless otherwise stated.

References SPS
Additional remarks In Amerika 300.000 personen die in aanmerking zouden komen voor het geneesmiddel, teruggerekend naar Nederland zou dat gaan 15.000 patiënten.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.