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ICATIBANT AUXILIA
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1823330
Name of medicinal product:
ICATIBANT AUXILIA
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:
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated May 9, 2022)
Package information leaflet (PIL):
EST
(last updated May 9, 2022)
Labelling:
(last updated May 9, 2022)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Auxilia Pharma OÜ
Marketing authorization number:
1062122
Marketing authorization issued on:
May 9, 2022
Marketing authorization expires on:
May 9, 2027
Marketing authorization procedure type:
National
Prices
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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