🇺🇸 Test in United States

FDA authorised Test on 5 October 2010 · 276 US adverse-event reports

Marketing authorisation

FDA — authorised 5 October 2010

  • Application: NDA022368
  • Marketing authorisation holder: PHARMAXIS EUROPE
  • Status: approved

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.

Most-reported reactions

  1. Dizziness — 33 reports (11.96%)
  2. Dyspnoea — 33 reports (11.96%)
  3. Fatigue — 28 reports (10.14%)
  4. Headache — 28 reports (10.14%)
  5. Diarrhoea — 27 reports (9.78%)
  6. Drug Ineffective — 27 reports (9.78%)
  7. Nausea — 27 reports (9.78%)
  8. Asthenia — 25 reports (9.06%)
  9. Pruritus — 24 reports (8.7%)
  10. Rash — 24 reports (8.7%)

Source database →

Frequently asked questions

Is Test approved in United States?

Yes. FDA authorised it on 5 October 2010.

Who is the marketing authorisation holder for Test in United States?

PHARMAXIS EUROPE holds the US marketing authorisation.