🇺🇸 Innohep (tinzaparin) in United States

FDA authorised Innohep (tinzaparin) on 14 July 2000 · 72 US adverse-event reports

Marketing authorisation

FDA — authorised 14 July 2000

  • Application: NDA020484
  • Marketing authorisation holder: LEO PHARMA AS
  • Local brand name: INNOHEP
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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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. Incorrect Drug Administration Duration — 12 reports (16.67%)
  2. Off Label Use — 11 reports (15.28%)
  3. Maternal Exposure During Pregnancy — 9 reports (12.5%)
  4. Exposure During Pregnancy — 8 reports (11.11%)
  5. Pulmonary Embolism — 8 reports (11.11%)
  6. Deep Vein Thrombosis — 7 reports (9.72%)
  7. Caesarean Section — 5 reports (6.94%)
  8. Abdominal Pain — 4 reports (5.56%)
  9. Anaemia — 4 reports (5.56%)
  10. Ascites — 4 reports (5.56%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is Innohep (tinzaparin) approved in United States?

Yes. FDA authorised it on 14 July 2000.

Who is the marketing authorisation holder for Innohep (tinzaparin) in United States?

LEO PHARMA AS holds the US marketing authorisation.