FDA — authorised 14 December 2018
- Application: BLA761091
- Marketing authorisation holder: CELLTRION INC
- Status: supplemented
🇺🇸 Herzuma in United States
FDA authorised Herzuma on 14 December 2018
Marketing authorisations
FDA
- Status: approved
Herzuma 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 Herzuma approved in United States?
Yes. FDA authorised it on 14 December 2018; FDA has authorised it.
Who is the marketing authorisation holder for Herzuma in United States?
CELLTRION INC holds the US marketing authorisation.