BERINERT SC
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1836525
Name of medicinal product:
BERINERT SC
Active substances:
C1-inhibitor, plasma derived
Estonian
,
English
,
Latin
ATC code:
B06AC01
Dosage form:
powder and solvent for solution for injection
Route of administration:
subcutaneous use
Strengh:
2000RÜ
Amount in package:
1TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
lahusti 4 ml
Indication:
Berinert for subcutaneous injection is indicated for prevention of recurrent Hereditary Angioedema (HAE) attacks in adolescent and adult patients with C1-esterase inhibitor deficiency.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated 05 April 2022)
Package information leaflet (PIL):
EST
(last updated 05 January 2022)
Labelling:
(last updated 05 January 2022)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
CSL Behring GmbH
Marketing authorization number:
1037121
Marketing authorization issued on:
11 August 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: 18 October 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription