EMA — authorised 11 July 2008
- Marketing authorisation holder: Shire Pharmaceuticals Ireland Limited
- Status: approved
🇪🇺 Firazyr in European Union
EMA authorised Firazyr on 11 July 2008
Marketing authorisations
EMA — authorised 16 July 2021
- Application: EMEA/H/C/005083
- Marketing authorisation holder: Accord Healthcare S.L.U.
- Local brand name: Icatibant Accord
- 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.
- Status: approved
Firazyr in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in European Union
Frequently asked questions
Is Firazyr approved in European Union?
Yes. EMA authorised it on 11 July 2008; EMA authorised it on 16 July 2021.
Who is the marketing authorisation holder for Firazyr in European Union?
Shire Pharmaceuticals Ireland Limited holds the EU marketing authorisation.