FDA — authorised 1 November 2013
- Application: BLA125486
- Marketing authorisation holder: GENENTECH
- Local brand name: GAZYVA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Gazyva in United States
FDA authorised Gazyva on 1 November 2013
Marketing authorisation
Gazyva in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Gazyva approved in United States?
Yes. FDA authorised it on 1 November 2013.
Who is the marketing authorisation holder for Gazyva in United States?
GENENTECH holds the US marketing authorisation.