FDA — authorised 15 June 2023
- Application: BLA761309
- Marketing authorisation holder: GENENTECH INC
- Local brand name: COLUMVI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 COLUMVI in United States
FDA authorised COLUMVI on 15 June 2023
Marketing authorisations
FDA
- Status: approved
COLUMVI 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 COLUMVI approved in United States?
Yes. FDA authorised it on 15 June 2023; FDA has authorised it.
Who is the marketing authorisation holder for COLUMVI in United States?
GENENTECH INC holds the US marketing authorisation.