Register of
Medicinal Products

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 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 
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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