🇺🇸 Elucirem in United States

FDA authorised Elucirem on 21 September 2022 · 55 US adverse-event reports

Marketing authorisations

FDA — authorised 21 September 2022

  • Application: NDA216986
  • Marketing authorisation holder: GUERBET
  • Local brand name: ELUCIREM
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

Read official source →

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. Urticaria — 10 reports (18.18%)
  2. Anaphylactic Reaction — 9 reports (16.36%)
  3. Pruritus — 7 reports (12.73%)
  4. Rash — 7 reports (12.73%)
  5. Contrast Media Reaction — 5 reports (9.09%)
  6. Dyspnoea — 4 reports (7.27%)
  7. Sneezing — 4 reports (7.27%)
  8. Cough — 3 reports (5.45%)
  9. Hypersensitivity — 3 reports (5.45%)
  10. Nausea — 3 reports (5.45%)

Source database →

Elucirem 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 Elucirem approved in United States?

Yes. FDA authorised it on 21 September 2022; FDA has authorised it.

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

GUERBET holds the US marketing authorisation.