🇺🇸 Extended half-life FVIII concentrates with PK-guided dosing in United States

Extended half-life FVIII concentrates with PK-guided dosing (Extended half-life FVIII concentrates with PK-guided dosing) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Extended half-life FVIII concentrates with PK-guided dosing 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 Extended half-life FVIII concentrates with PK-guided dosing approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Extended half-life FVIII concentrates with PK-guided dosing in United States?

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