FDA
- Status: approved
1 US adverse-event reports
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA has authorised it.
Etienne Xavier Keller is the originator. The local marketing authorisation holder may differ — check the official source linked above.