FDA — authorised 9 February 1996
- Application: NDA020372
- Marketing authorisation holder: MEDI-PHYSICS
- Local brand name: MYOVIEW 30ML
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Myoview in United States
FDA authorised Myoview on 9 February 1996 · 68 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: 68
Most-reported reactions
- Hypotension — 11 reports (16.18%)
- Blood Pressure Increased — 8 reports (11.76%)
- Dizziness — 8 reports (11.76%)
- Dyspnoea — 7 reports (10.29%)
- Renal Failure — 7 reports (10.29%)
- Lethargy — 6 reports (8.82%)
- Mental Status Changes — 6 reports (8.82%)
- Nausea — 6 reports (8.82%)
- Scan Abnormal — 5 reports (7.35%)
- Blister — 4 reports (5.88%)
Myoview 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 Myoview approved in United States?
Yes. FDA authorised it on 9 February 1996.
Who is the marketing authorisation holder for Myoview in United States?
MEDI-PHYSICS holds the US marketing authorisation.