FDA — authorised 6 February 2019
- Application: BLA761112
- Marketing authorisation holder: ABLYNX NV
- Status: supplemented
🇺🇸 Cablivi in United States
FDA authorised Cablivi on 6 February 2019
Marketing authorisations
FDA
- Status: approved
Cablivi 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 Cablivi approved in United States?
Yes. FDA authorised it on 6 February 2019; FDA has authorised it.
Who is the marketing authorisation holder for Cablivi in United States?
ABLYNX NV holds the US marketing authorisation.