Icatibant Accord (icatibant)
Generic
- Region
- 🇪🇺 EU
- Active substance
- icatibant
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Angioedemas, Hereditary
- CHMP opinion
- Thu 20 May 2021
- EU approval
- Fri 16 Jul 2021
- Designations
- Generic
- Application
- EMEA/H/C/005083
- ATC
- B06AC02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Firazyr Authorised · Takeda Pharmaceuticals International AG
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.