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EMPESIN
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1728749
Name of medicinal product:
EMPESIN
Active substances:
Argipressin
Estonian
,
English
,
Latin
ATC code:
H01BA01
Dosage form:
concentrate for solution for infusion
Route of administration:
intravenous use
Strengh:
20RÜ 1ml
Amount in package:
2ml 10TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Empressin is indicated for the treatment of catecholamine refractory hypotension following septic shock in patients older than 18 years. A catecholamine refractory hypotension is present if the mean arterial blood pressure cannot be stabilised to target despite adequate volume substitution and application of catecholamines (see section 5.1).
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated November 26, 2020)
Package information leaflet (PIL):
EST
(last updated December 27, 2021)
Labelling:
(last updated April 3, 2018)
Last imported to Estonia:
October 31, 2023
Marketing authorization
Marketing authorization holder:
Orpha-Devel Handels und Vertriebs GmbH
Marketing authorization number:
963118
Marketing authorization issued on:
April 3, 2018
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Mutual recognition
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: July 4, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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