🇺🇸 Plasma-derived FVIII/VWF concentrate in United States
12 US adverse-event reports
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: 12
Most-reported reactions
- Haemorrhage — 2 reports (16.67%)
- Pulmonary Embolism — 2 reports (16.67%)
- Cardiomegaly — 1 report (8.33%)
- Device Related Infection — 1 report (8.33%)
- Drug Intolerance — 1 report (8.33%)
- Factor Viii Inhibition — 1 report (8.33%)
- Infection — 1 report (8.33%)
- Pneumonia — 1 report (8.33%)
- Pneumothorax — 1 report (8.33%)
- Right Ventricular Failure — 1 report (8.33%)
Other Hematology approved in United States
Frequently asked questions
Is Plasma-derived FVIII/VWF concentrate approved in United States?
Plasma-derived FVIII/VWF concentrate does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for Plasma-derived FVIII/VWF concentrate in United States?
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the originator. The local marketing authorisation holder may differ — check the official source linked above.