Label Changes for:
Soliris (Eculizumab) Concentrated Solution For Intravenous Infusion
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012
- As with all proteins, there is a potential for immunogenicity with Eculizumab….