🇺🇸 Haemostatic solution "Haemoblock" application in United States

FDA authorised Haemostatic solution "Haemoblock" application on 22 October 2004 · 123,244 US adverse-event reports

Marketing authorisation

FDA — authorised 22 October 2004

• Application: NDA050801
• Marketing authorisation holder: NORVIUM BIOSCIENCE
• Status: supplemented

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.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 123,244

Most-reported reactions

1. Application Site Erythema — 25,533 reports (20.72%)
2. Application Site Pruritus — 21,948 reports (17.81%)
3. Application Site Pain — 21,252 reports (17.24%)
4. Application Site Rash — 13,381 reports (10.86%)
5. Application Site Irritation — 11,974 reports (9.72%)
6. Application Site Reaction — 6,936 reports (5.63%)
7. Application Site Vesicles — 6,366 reports (5.17%)
8. Drug Ineffective — 6,063 reports (4.92%)
9. Off Label Use — 4,943 reports (4.01%)
10. Application Site Swelling — 4,848 reports (3.93%)

Source database →

Frequently asked questions

Is Haemostatic solution "Haemoblock" application approved in United States?

Yes. FDA authorised it on 22 October 2004.

Who is the marketing authorisation holder for Haemostatic solution "Haemoblock" application in United States?

NORVIUM BIOSCIENCE holds the US marketing authorisation.