🇺🇸 Heliox in United States

FDA authorised Heliox on 5 July 2013 · 49 US adverse-event reports

Marketing authorisations

FDA — authorised 5 July 2013

  • Application: NDA205767
  • Marketing authorisation holder: LINDE NORTH AMERICA INC
  • Status: approved

FDA — authorised 21 July 2013

  • Application: NDA205849
  • Marketing authorisation holder: PRAXAIR INC
  • Status: approved

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. Drug Ineffective — 16 reports (32.65%)
  2. Condition Aggravated — 5 reports (10.2%)
  3. Off Label Use — 5 reports (10.2%)
  4. Dyspnoea — 4 reports (8.16%)
  5. Pneumonia — 4 reports (8.16%)
  6. Acute Respiratory Failure — 3 reports (6.12%)
  7. Agranulocytosis — 3 reports (6.12%)
  8. Dermatitis Bullous — 3 reports (6.12%)
  9. Hypoxia — 3 reports (6.12%)
  10. Maternal Exposure During Pregnancy — 3 reports (6.12%)

Source database →

Heliox 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 Heliox approved in United States?

Yes. FDA authorised it on 5 July 2013; FDA authorised it on 21 July 2013; FDA has authorised it.

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

LINDE NORTH AMERICA INC holds the US marketing authorisation.