🇺🇸 Enzyme replacement in United States

11 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. Anaemia — 2 reports (18.18%)
  2. Abdominal Distension — 1 report (9.09%)
  3. Abdominal Sepsis — 1 report (9.09%)
  4. Acidosis — 1 report (9.09%)
  5. Acquired Aminoaciduria — 1 report (9.09%)
  6. Beta 2 Microglobulin Urine Increased — 1 report (9.09%)
  7. Blood Calcium Decreased — 1 report (9.09%)
  8. Blood Phosphorus Decreased — 1 report (9.09%)
  9. Blood Uric Acid Decreased — 1 report (9.09%)
  10. Body Fat Disorder — 1 report (9.09%)

Source database →

Enzyme replacement 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 Enzyme replacement approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Enzyme replacement in United States?

Rigshospitalet, Denmark is the originator. The local marketing authorisation holder may differ — check the official source linked above.