🇺🇸 MIBOLERONE in United States

MIBOLERONE (MIBOLERONE) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

MIBOLERONE 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 MIBOLERONE approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.