EMA — authorised 2 March 2020
- Marketing authorisation holder: Alnylam Netherlands B.V.
- Status: approved
🇪🇺 Givlaari in European Union
EMA authorised Givlaari on 2 March 2020
Marketing authorisations
EMA — authorised 2 March 2020
- Application: EMEA/H/C/004775
- Marketing authorisation holder: Alnylam Netherlands B.V.
- Local brand name: Givlaari
- Indication: Treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
- Pathway: orphan, PRIME
- Status: approved
Givlaari 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 Givlaari approved in European Union?
Yes. EMA authorised it on 2 March 2020; EMA authorised it on 2 March 2020.
Who is the marketing authorisation holder for Givlaari in European Union?
Alnylam Netherlands B.V. holds the EU marketing authorisation.