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Drug

Icatibant acetate

Approved · EMA

Also known as Firazyr, Icatibant.

RxNorm1294605
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Icatibant Accord (EMA)

Regulatory2021-07-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Icatibant acetate
Aliases & brands
FirazyrIcatibant
RxNorm CUI
1294605
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-07-16
Latest approval
2021-07-16
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2021-07-16Approval
Approval: Icatibant Accord (EMA)
Indication: Icatibant Accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1… Show full indication

Icatibant Accord 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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Regulatory event sources are credited in the Regulatory Timeline above.