FDA — authorised 11 October 2024
- Application: BLA761369
- Marketing authorisation holder: PFIZER INC
- Local brand name: HYMPAVZI
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 Hympavzi in United States
FDA authorised Hympavzi on 11 October 2024
Marketing authorisations
FDA
- Status: approved
Hympavzi 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 Hympavzi approved in United States?
Yes. FDA authorised it on 11 October 2024; FDA has authorised it.
Who is the marketing authorisation holder for Hympavzi in United States?
PFIZER INC holds the US marketing authorisation.