EMA — authorised 30 April 2021
- Marketing authorisation holder: BioCryst Ireland Limited
- Status: approved
🇪🇺 Orladeyo in European Union
EMA authorised Orladeyo on 30 April 2021
Marketing authorisations
EMA — authorised 30 April 2021
- Application: EMEA/H/C/005138
- Marketing authorisation holder: BioCryst Ireland Limited
- Local brand name: Orladeyo
- Indication: Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
- Status: approved
Orladeyo 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 Orladeyo approved in European Union?
Yes. EMA authorised it on 30 April 2021; EMA authorised it on 30 April 2021.
Who is the marketing authorisation holder for Orladeyo in European Union?
BioCryst Ireland Limited holds the EU marketing authorisation.