🇺🇸 OAC monotherapy in United States

OAC monotherapy (OAC monotherapy) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

OAC monotherapy 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 OAC monotherapy approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for OAC monotherapy in United States?

St. Antonius Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.