🇺🇸 concentrated FVIII in United States

concentrated FVIII (concentrated FVIII) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

concentrated FVIII 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 concentrated FVIII approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for concentrated FVIII in United States?

Beijing Children's Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.