🇺🇸 CardioGen-82 in United States

FDA authorised CardioGen-82 on 29 December 1989 · 183 US adverse-event reports

Marketing authorisations

FDA — authorised 29 December 1989

  • Application: NDA019414
  • Marketing authorisation holder: BRACCO
  • Local brand name: CARDIOGEN-82
  • Indication: INJECTABLE — INJECTION
  • 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. No Adverse Event — 77 reports (42.08%)
  2. Expired Product Administered — 26 reports (14.21%)
  3. Wrong Technique In Product Usage Process — 25 reports (13.66%)
  4. Product Preparation Error — 21 reports (11.48%)
  5. Radiation Overdose — 8 reports (4.37%)
  6. Exposure To Radiation — 7 reports (3.83%)
  7. Off Label Use — 6 reports (3.28%)
  8. Drug Ineffective — 5 reports (2.73%)
  9. Therapeutic Response Unexpected — 4 reports (2.19%)
  10. Wrong Technique In Drug Usage Process — 4 reports (2.19%)

Source database →

CardioGen-82 in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is CardioGen-82 approved in United States?

Yes. FDA authorised it on 29 December 1989; FDA has authorised it.

Who is the marketing authorisation holder for CardioGen-82 in United States?

BRACCO holds the US marketing authorisation.