FDA
- Status: approved
🇺🇸 Standard approach in United States
Standard approach (Standard approach) regulatory status in United States.
Marketing authorisation
Standard approach 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 Standard approach approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Standard approach in United States?
Clinical Hospital Colentina is the originator. The local marketing authorisation holder may differ — check the official source linked above.