FDA
- Status: approved
🇺🇸 FM+R in United States
FM+R (FM+R) regulatory status in United States.
Marketing authorisation
FM+R 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 FM+R approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for FM+R in United States?
University of Bologna is the originator. The local marketing authorisation holder may differ — check the official source linked above.