FDA — authorised 25 April 2019
- Application: BLA761066
- Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
- Local brand name: ETICOVO
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ETICOVO in United States
FDA authorised ETICOVO on 25 April 2019
Marketing authorisations
FDA
- Status: approved
ETICOVO 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 ETICOVO approved in United States?
Yes. FDA authorised it on 25 April 2019; FDA has authorised it.
Who is the marketing authorisation holder for ETICOVO in United States?
SAMSUNG BIOEPIS CO LTD holds the US marketing authorisation.