🇺🇸 Cathflo Activase in United States

FDA authorised Cathflo Activase on 13 November 1987 · 3,074 US adverse-event reports

Marketing authorisations

FDA — authorised 13 November 1987

  • Application: BLA103172
  • Marketing authorisation holder: GENENTECH
  • 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. No Adverse Event — 1,343 reports (43.69%)
  2. Off Label Use — 698 reports (22.71%)
  3. Product Storage Error — 310 reports (10.08%)
  4. Intercepted Product Storage Error — 187 reports (6.08%)
  5. Intercepted Medication Error — 161 reports (5.24%)
  6. Drug Ineffective — 117 reports (3.81%)
  7. Death — 103 reports (3.35%)
  8. Nausea — 54 reports (1.76%)
  9. Fatigue — 51 reports (1.66%)
  10. Pyrexia — 50 reports (1.63%)

Source database →

Cathflo Activase 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 Cathflo Activase approved in United States?

Yes. FDA authorised it on 13 November 1987; FDA has authorised it.

Who is the marketing authorisation holder for Cathflo Activase in United States?

GENENTECH holds the US marketing authorisation.