Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
BERINERT IV
|
Active substances:
|
|
ATC code:
|
B06AC01
|
Dosage form:
|
powder and solvent for solution for injection/infusion
|
Strength:
|
500RÜ
|
Legal status for supply*:
|
Subject to medicinal prescription
|
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)
|
Indication:
|
Hereditary angioedema type I and II (HAE)
Treatment and pre-procedure prevention of acute episodes.
|
Safety features:
|
Yes
|
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
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1836503
|
BERINERT IV
|
powder and solvent for solution for injection/infusion
|
500RÜ 1TK
|
Prescription
|
|
|
17.10.2023
|
|
lahusti 10 ml
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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