FIRAZYR

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Spain, UK.

Active ingredients

The drug FIRAZYR contains one active pharmaceutical ingredient (API):

1
UNII 325O8467XK - ICATIBANT ACETATE
 

Icatibant is a selective competitive antagonist at the bradykinin type 2 (B2) receptor. It is a synthetic decapeptide with a structure similar to bradykinin, but with 5 non-proteinogenic amino acids. In HAE increased bradykinin concentrations are the key mediator in the development of the clinical symptoms.

 
Read more about Icatibant

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 FIRAZYR Solution for injection MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
B06AC02 Icatibant B Blood and blood forming organs → B06 Other hematological agents → B06A Other hematological agents → B06AC Drugs used in hereditary angioedema
Discover more medicines within B06AC02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
BR Câmara de Regulação do Mercado de Medicamentos 501121040039017
CA Health Products and Food Branch 02425696
EE Ravimiamet 1381632, 1523607
ES Centro de información online de medicamentos de la AEMPS 08461001
FI Lääkealan turvallisuus- ja kehittämiskeskus 146529
FR Base de données publique des médicaments 61680479
GB Medicines & Healthcare Products Regulatory Agency 150324
HK Department of Health Drug Office 66935
IE Health Products Regulatory Authority 88148
IL מִשְׂרַד הַבְּרִיאוּת 6312
JP 医薬品医療機器総合機構 4490406G1029
LT Valstybinė vaistų kontrolės tarnyba 1033654, 1063755
NL Z-Index G-Standaard, PRK 128635
NZ Medicines and Medical Devices Safety Authority 17717
PL Rejestru Produktów Leczniczych 100218256
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W68202001
US FDA, National Drug Code 54092-702

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