Register of
Medicinal Products

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 February 8, 2022)
Package information leaflet (PIL): EST  (last updated February 8, 2022)
Labelling:  (last updated February 8, 2022)
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 8, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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