🇺🇸 rFVIIa in United States

28 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. Factor Viii Inhibition — 4 reports (14.29%)
  2. Treatment Failure — 4 reports (14.29%)
  3. Arthralgia — 3 reports (10.71%)
  4. Joint Swelling — 3 reports (10.71%)
  5. Muscle Haemorrhage — 3 reports (10.71%)
  6. Pulmonary Embolism — 3 reports (10.71%)
  7. Atrial Thrombosis — 2 reports (7.14%)
  8. Device Related Infection — 2 reports (7.14%)
  9. Drug Ineffective — 2 reports (7.14%)
  10. Haemorrhage — 2 reports (7.14%)

Source database →

rFVIIa 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 rFVIIa approved in United States?

Yes. FDA has authorised it.

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

Fondazione IRCCS Policlinico San Matteo di Pavia is the originator. The local marketing authorisation holder may differ — check the official source linked above.