FDA
- Status: approved
🇺🇸 Monorova in United States
2 US adverse-event reports
Marketing authorisation
Safety signals — FAERS
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 2
Most-reported reactions
- Incorrect Product Administration Duration — 1 report (50%)
- Off Label Use — 1 report (50%)
Monorova 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 Monorova approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Monorova in United States?
Yuhan Corporation is the originator. The local marketing authorisation holder may differ — check the official source linked above.