FDA — authorised 9 May 2023
- Application: BLA761161
- Marketing authorisation holder: CHIESI FARMACEUTICI SPA
- Local brand name: ELFABRIO
- Indication: VIAL — SINGLE-USE
- Status: approved
🇺🇸 ELFABRIO in United States
FDA authorised ELFABRIO on 9 May 2023
Marketing authorisations
FDA
- Status: approved
ELFABRIO in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is ELFABRIO approved in United States?
Yes. FDA authorised it on 9 May 2023; FDA has authorised it.
Who is the marketing authorisation holder for ELFABRIO in United States?
CHIESI FARMACEUTICI SPA holds the US marketing authorisation.