FDA — authorised 6 December 2023
- Application: BLA761198
- Marketing authorisation holder: BIO-THERA SOLUTIONS LTD
- Local brand name: AVZIVI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 AVZIVI in United States
FDA authorised AVZIVI on 6 December 2023
Marketing authorisations
FDA
- Status: approved
AVZIVI in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is AVZIVI approved in United States?
Yes. FDA authorised it on 6 December 2023; FDA has authorised it.
Who is the marketing authorisation holder for AVZIVI in United States?
BIO-THERA SOLUTIONS LTD holds the US marketing authorisation.