FDA — authorised 21 April 2017
- Application: BLA761054
- Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
- Local brand name: RENFLEXIS
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 RENFLEXIS in United States
FDA authorised RENFLEXIS on 21 April 2017
Marketing authorisations
FDA
- Status: approved
RENFLEXIS 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 RENFLEXIS approved in United States?
Yes. FDA authorised it on 21 April 2017; FDA has authorised it.
Who is the marketing authorisation holder for RENFLEXIS in United States?
SAMSUNG BIOEPIS CO LTD holds the US marketing authorisation.