🇺🇸 Amnio-Maxx® Dual Layer Amnion Patch in United States

Amnio-Maxx® Dual Layer Amnion Patch (Amnio-Maxx® Dual Layer Amnion Patch) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Amnio-Maxx® Dual Layer Amnion Patch 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 Amnio-Maxx® Dual Layer Amnion Patch approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Amnio-Maxx® Dual Layer Amnion Patch in United States?

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