🇺🇸 Mozobil in United States

FDA authorised Mozobil on 15 December 2008 · 366 US adverse-event reports

Marketing authorisations

FDA — authorised 15 December 2008

  • Application: NDA022311
  • Marketing authorisation holder: GENZYME
  • 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. Diarrhoea — 57 reports (15.57%)
  2. Nausea — 44 reports (12.02%)
  3. Febrile Neutropenia — 42 reports (11.48%)
  4. Thrombocytopenia — 37 reports (10.11%)
  5. Pyrexia — 36 reports (9.84%)
  6. Vomiting — 34 reports (9.29%)
  7. Fatigue — 32 reports (8.74%)
  8. Pneumonia — 30 reports (8.2%)
  9. Off Label Use — 29 reports (7.92%)
  10. Ascites — 25 reports (6.83%)

Source database →

Mozobil in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Mozobil approved in United States?

Yes. FDA authorised it on 15 December 2008; FDA has authorised it.

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

GENZYME holds the US marketing authorisation.