Register of
Medicinal Products

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 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 
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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