🇺🇸 Mircera in United States

FDA authorised Mircera on 14 November 2007 · 486 US adverse-event reports

Marketing authorisation

FDA — authorised 14 November 2007

  • Application: BLA125164
  • Marketing authorisation holder: HOFFMAN-LA ROCHE
  • Local brand name: MIRCERA
  • Indication: SOLUTION — INJECTION
  • Status: approved

Read official source →

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. Death — 79 reports (16.26%)
  2. Hypertension — 75 reports (15.43%)
  3. Haemoglobin Decreased — 59 reports (12.14%)
  4. Pneumonia — 57 reports (11.73%)
  5. Anaemia — 52 reports (10.7%)
  6. Cardiac Failure — 41 reports (8.44%)
  7. Sepsis — 35 reports (7.2%)
  8. Fall — 31 reports (6.38%)
  9. Renal Impairment — 30 reports (6.17%)
  10. Acute Myocardial Infarction — 27 reports (5.56%)

Source database →

Mircera in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Mircera approved in United States?

Yes. FDA authorised it on 14 November 2007.

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

HOFFMAN-LA ROCHE holds the US marketing authorisation.