🇺🇸 OPUVIZ in United States

FDA authorised OPUVIZ on 20 May 2024

Marketing authorisations

FDA — authorised 20 May 2024

  • Application: BLA761350
  • Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
  • Local brand name: OPUVIZ
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA

  • Status: approved

OPUVIZ 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 OPUVIZ approved in United States?

Yes. FDA authorised it on 20 May 2024; FDA has authorised it.

Who is the marketing authorisation holder for OPUVIZ in United States?

SAMSUNG BIOEPIS CO LTD holds the US marketing authorisation.