Label Changes for:

Soliris (Eculizumab) Concentrated Solution For Intravenous Infusion

December 2012

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

 

ADVERSE REACTIONS

  • As with all proteins, there is a potential for immunogenicity with Eculizumab….

 

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