FDA — authorised 20 November 2019
- Marketing authorisation holder: ALNYLAM PHARMS INC
- Status: approved
🇺🇸 Givlaari in United States
FDA authorised Givlaari on 20 November 2019
Marketing authorisations
FDA — authorised 20 November 2019
- Application: NDA212194
- Marketing authorisation holder: ALNYLAM PHARMS INC
- Local brand name: GIVLAARI
- Indication: SOLUTION — SUBCUTANEOUS
- 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 United States
Frequently asked questions
Is Givlaari approved in United States?
Yes. FDA authorised it on 20 November 2019; FDA authorised it on 20 November 2019.
Who is the marketing authorisation holder for Givlaari in United States?
ALNYLAM PHARMS INC holds the US marketing authorisation.