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BERINERT IV
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1836503
Name of medicinal product:
BERINERT IV
Active substances:
C1-inhibitor, plasma derived
Estonian
,
English
,
Latin
ATC code:
B06AC01
Dosage form:
powder and solvent for solution for injection/infusion
Route of administration:
intravenous use
Strengh:
500RÜ
Amount in package:
1TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
lahusti 10 ml
Indication:
Hereditary angioedema type I and II (HAE) Treatment and pre-procedure prevention of acute episodes.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated January 5, 2022)
Package information leaflet (PIL):
EST
(last updated January 5, 2022)
Labelling:
(last updated January 5, 2022)
Last imported to Estonia:
January 17, 2023
Marketing authorization
Marketing authorization holder:
CSL Behring GmbH
Marketing authorization number:
1036921
Marketing authorization issued on:
August 11, 2021
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: May 9, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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