FDA
- Status: approved
🇺🇸 Systemic in United States
Systemic (Systemic) regulatory status in United States.
Marketing authorisation
Systemic 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 Systemic approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Systemic in United States?
Fraunhofer-Institute of Toxicology and Experimental Medicine is the originator. The local marketing authorisation holder may differ — check the official source linked above.