🇺🇸 BETIBEGLOGENE AUTOTEMCEL in United States

8 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. Acute Myeloid Leukaemia — 3 reports (37.5%)
  2. Endocrine Disorder — 1 report (12.5%)
  3. Hypothalamo-Pituitary Disorder — 1 report (12.5%)
  4. Leukaemia Recurrent — 1 report (12.5%)
  5. Minimal Residual Disease — 1 report (12.5%)
  6. Off Label Use — 1 report (12.5%)

Source database →

BETIBEGLOGENE AUTOTEMCEL 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 BETIBEGLOGENE AUTOTEMCEL approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for BETIBEGLOGENE AUTOTEMCEL in United States?

Marketing authorisation holder not available in our data.