FDA — authorised 16 November 2017
- Marketing authorisation holder: GENENTECH INC
- Status: approved
🇺🇸 Hemlibra in United States
FDA authorised Hemlibra on 16 November 2017
Marketing authorisation
Hemlibra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Hemlibra approved in United States?
Yes. FDA authorised it on 16 November 2017.
Who is the marketing authorisation holder for Hemlibra in United States?
GENENTECH INC holds the US marketing authorisation.