Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1381632
Name of medicinal product: FIRAZYR
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 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: nõel 1 TK
Indication: Firazyr 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):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: June 30, 2022
Marketing authorization holder: Takeda Pharmaceuticals International AG Ireland Branch 
Marketing authorization number: EU/1/08/461 
Marketing authorization issued on: July 15, 2008 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 10, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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