🇺🇸 human coagulation Factor IX in United States

human coagulation Factor IX (human coagulation Factor IX) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

human coagulation Factor IX in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is human coagulation Factor IX approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for human coagulation Factor IX in United States?

Prothya Biosolutions is the originator. The local marketing authorisation holder may differ — check the official source linked above.