🇺🇸 Drug: "Tocilizmab" in United States

FDA authorised Drug: "Tocilizmab" on 8 June 1992 · 5,845 US adverse-event reports

Marketing authorisations

FDA — authorised 8 June 1992

  • Application: NDA020066
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Status: supplemented

FDA — authorised 12 April 1993

  • Application: NDA019658
  • Marketing authorisation holder: BAYER HEALTHCARE LLC
  • Status: supplemented

FDA — authorised 8 December 1995

  • Application: NDA019835
  • Marketing authorisation holder: KENVUE BRANDS
  • Status: supplemented

FDA — authorised 16 December 2008

  • Application: ANDA079096
  • Marketing authorisation holder: AMNEAL PHARMS NY
  • Status: supplemented

FDA — authorised 28 December 2012

  • Application: ANDA202071
  • Marketing authorisation holder: SHREE HARI INTL
  • Status: approved

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. Nausea — 937 reports (16.03%)
  2. Drug Ineffective — 600 reports (10.27%)
  3. Dyspnoea — 576 reports (9.85%)
  4. Pain — 574 reports (9.82%)
  5. Vomiting — 573 reports (9.8%)
  6. Dizziness — 551 reports (9.43%)
  7. Blood Glucose Increased — 537 reports (9.19%)
  8. Diarrhoea — 514 reports (8.79%)
  9. Fatigue — 500 reports (8.55%)
  10. Pyrexia — 483 reports (8.26%)

Source database →

Drug: "Tocilizmab" 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 Drug: "Tocilizmab" approved in United States?

Yes. FDA authorised it on 8 June 1992; FDA authorised it on 12 April 1993; FDA authorised it on 8 December 1995.

Who is the marketing authorisation holder for Drug: "Tocilizmab" in United States?

HALEON US HOLDINGS holds the US marketing authorisation.