FDA — authorised 10 June 2019
- Application: BLA761121
- Marketing authorisation holder: GENENTECH
- Local brand name: POLIVY
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Polatuzumab, bendamustin und rituximab in United States
FDA authorised Polatuzumab, bendamustin und rituximab on 10 June 2019
Marketing authorisation
Polatuzumab, bendamustin und rituximab in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Polatuzumab, bendamustin und rituximab approved in United States?
Yes. FDA authorised it on 10 June 2019.
Who is the marketing authorisation holder for Polatuzumab, bendamustin und rituximab in United States?
GENENTECH holds the US marketing authorisation.