FDA — authorised 23 July 2019
- Application: BLA761059
- Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
- Local brand name: HADLIMA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 HADLIMA in United States
FDA authorised HADLIMA on 23 July 2019
Marketing authorisations
FDA
- Status: approved
HADLIMA 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 HADLIMA approved in United States?
Yes. FDA authorised it on 23 July 2019; FDA has authorised it.
Who is the marketing authorisation holder for HADLIMA in United States?
SAMSUNG BIOEPIS CO LTD holds the US marketing authorisation.