Product class:
|
Medicinal product with marketing authorization
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Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ICATIBANT FRESENIUS
|
Active substances:
|
|
ATC code:
|
B06AC02
|
Dosage form:
|
solution for injection in pre-filled syringe
|
Strength:
|
30mg 3ml
|
Legal status for supply*:
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Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated February 8, 2022)
|
Package information leaflet (PIL):
|
EST (last updated February 8, 2022)
|
Labelling:
|
(last updated February 8, 2022)
|
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
|
Marketing authorization holder:
|
Fresenius Kabi Polska Sp. z o.o.
|
Marketing authorization number:
|
1051822
|
Marketing authorization issued on:
|
February 8, 2022
|
Marketing authorization expires on:
|
February 8, 2027
|
Marketing authorization procedure type:
|
Decentralised
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1822913
|
ICATIBANT FRESENIUS
|
solution for injection in pre-filled syringe
|
30mg 3ml 3ml 1TK
|
Prescription
|
|
|
|
|
|
1822924
|
ICATIBANT FRESENIUS
|
solution for injection in pre-filled syringe
|
30mg 3ml 3ml 3TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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