🇺🇸 Elaprase in United States

FDA authorised Elaprase on 24 July 2006 · 1,069 US adverse-event reports

Marketing authorisations

FDA — authorised 24 July 2006

  • Application: BLA125151
  • Marketing authorisation holder: SHIRE
  • Status: supplemented

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 — 258 reports (24.13%)
  2. Pyrexia — 176 reports (16.46%)
  3. Death — 115 reports (10.76%)
  4. Pneumonia — 97 reports (9.07%)
  5. Dyspnoea — 94 reports (8.79%)
  6. Urticaria — 84 reports (7.86%)
  7. Cough — 72 reports (6.74%)
  8. Rash — 62 reports (5.8%)
  9. Inappropriate Schedule Of Product Administration — 58 reports (5.43%)
  10. Convulsion — 53 reports (4.96%)

Source database →

Elaprase 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 Elaprase approved in United States?

Yes. FDA authorised it on 24 July 2006; FDA has authorised it.

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

SHIRE holds the US marketing authorisation.