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ICATIBANT TEVA
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1822957
Name of medicinal product:
ICATIBANT TEVA
Active substances:
Icatibant
Estonian
,
English
,
Latin
ATC code:
B06AC02
Dosage form:
solution for injection in pre-filled syringe
Route of administration:
subcutaneous use
Strengh:
10mg 1ml
Amount in package:
3ml 3TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
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 July 6, 2021)
Package information leaflet (PIL):
EST
(last updated July 6, 2021)
Labelling:
(last updated July 6, 2021)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Teva B.V.
Marketing authorization number:
1036221
Marketing authorization issued on:
July 6, 2021
Marketing authorization expires on:
July 6, 2026
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: July 6, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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