Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1853816
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: 5TK
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 April 5, 2022)
Package information leaflet (PIL): EST  (last updated January 5, 2022)
Labelling:  (last updated January 5, 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: CSL Behring GmbH 
Marketing authorization number: 1037121 
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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