🇺🇸 Prometa in United States

FDA authorised Prometa on 30 March 1992 · 11 US adverse-event reports

Marketing authorisations

FDA — authorised 30 March 1992

  • Application: ANDA073340
  • Marketing authorisation holder: MURO
  • Local brand name: PROMETA
  • Indication: SOLUTION — INHALATION
  • Status: approved

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FDA

  • 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. Diarrhoea — 2 reports (18.18%)
  2. Alcohol Abuse — 1 report (9.09%)
  3. Alopecia — 1 report (9.09%)
  4. Arthralgia — 1 report (9.09%)
  5. Atrial Fibrillation — 1 report (9.09%)
  6. Cataract — 1 report (9.09%)
  7. Contusion — 1 report (9.09%)
  8. Cytomegalovirus Infection — 1 report (9.09%)
  9. Death — 1 report (9.09%)
  10. Depression — 1 report (9.09%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Prometa approved in United States?

Yes. FDA authorised it on 30 March 1992; FDA has authorised it.

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

MURO holds the US marketing authorisation.