ICATIBANT FRESENIUS
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1822913
Name of medicinal product:
ICATIBANT FRESENIUS
Active substances:
Icatibant
Estonian
,
English
,
Latin
ATC code:
B06AC02
Dosage form:
solution for injection in pre-filled syringe
Route of administration:
subcutaneous use
Strengh:
30mg 3ml
Amount in package:
3ml 1TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Icatibant Fresenius is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated 08 February 2022)
Package information leaflet (PIL):
EST
(last updated 08 February 2022)
Labelling:
(last updated 08 February 2022)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Marketing authorization number:
1051822
Marketing authorization issued on:
08 February 2022
Marketing authorization expires on:
08 February 2027
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: 08 February 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription