🇺🇸 APAC in United States

APAC (APAC) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

APAC 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 APAC approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for APAC in United States?

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