🇺🇸 VPRIV in United States

FDA authorised VPRIV on 26 February 2010 · 366 US adverse-event reports

Marketing authorisations

FDA — authorised 26 February 2010

  • Application: BLA022575
  • Marketing authorisation holder: SHIRE HUMAN GENETIC
  • Local brand name: VPRIV
  • Indication: POWDER — 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. Infusion Related Reaction — 74 reports (20.22%)
  2. Death — 48 reports (13.11%)
  3. No Adverse Event — 47 reports (12.84%)
  4. Fatigue — 41 reports (11.2%)
  5. Headache — 29 reports (7.92%)
  6. Inappropriate Schedule Of Drug Administration — 28 reports (7.65%)
  7. Pyrexia — 28 reports (7.65%)
  8. Arthralgia — 24 reports (6.56%)
  9. Nausea — 24 reports (6.56%)
  10. Inappropriate Schedule Of Product Administration — 23 reports (6.28%)

Source database →

VPRIV 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 VPRIV approved in United States?

Yes. FDA authorised it on 26 February 2010; FDA has authorised it.

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

SHIRE HUMAN GENETIC holds the US marketing authorisation.