CanadaTAVNEOS (avacopan) capsules, 10 mg — identified by the product name and 10 mg strength — are affected. Health Canada is reviewing significant concerns about the data integrity of the pivotal ADVOCATE trial that served as the primary efficacy study supporting TAVNEOS’s authorization; see key messages above for what to do.
How to identify it
TAVNEOS (avacopan) capsules, 10 mg
The hazard
Health Canada is reviewing significant concerns regarding the data integrity of the pivotal ADVOCATE trial, which served as the primary efficacy study supporting the authorization of TAVNEOS (avacopan).
##
What to do
See key messages above
Where it was sold
National
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)