🇺🇸 Elucirem in United States

FDA authorised Elucirem on 21 September 2022 · 12 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. Chest Discomfort — 2 reports (16.67%)
  2. Nausea — 2 reports (16.67%)
  3. Abdominal Pain — 1 report (8.33%)
  4. Dyspnoea — 1 report (8.33%)
  5. Generalised Oedema — 1 report (8.33%)
  6. Hypervolaemia — 1 report (8.33%)
  7. Procedural Complication — 1 report (8.33%)
  8. Pruritus — 1 report (8.33%)
  9. Throat Tightness — 1 report (8.33%)
  10. Urticaria — 1 report (8.33%)

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.