🇺🇸 Rotarix vaccine in United States

Rotarix vaccine (Rotarix vaccine) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Rotarix vaccine 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 Rotarix vaccine approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Rotarix vaccine in United States?

Oxford University Clinical Research Unit, Vietnam is the originator. The local marketing authorisation holder may differ — check the official source linked above.