🇺🇸 FVIII concentrate in United States

4 US adverse-event reports

Marketing authorisation

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 — 1 report (25%)
  2. Factor Viii Inhibition — 1 report (25%)
  3. Parvovirus B19 Test Positive — 1 report (25%)
  4. Suspected Transmission Of An Infectious Agent Via Product — 1 report (25%)

Source database →

FVIII concentrate 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 FVIII concentrate approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for FVIII concentrate in United States?

Federico II University is the originator. The local marketing authorisation holder may differ — check the official source linked above.