Page:Ultomiris (ravulizumab-cwvz) injection (Corrected Supplement Approval).pdf/7

BLA 761108/S-021 Page 7 {|style="width:100%"
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 * style="width:50%"|Tanya Wroblewski, MD Associate Director of Therapeutic Review Division of Nonmalignant Hematology Office of Cardiology, Hematology, Endocrinology, and Nephrology Center for Drug Evaluation and Research
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ENCLOSURES:
 * • Content of Labeling
 * o Prescribing Information
 * o Medication Guide
 * o Instructions for Use
 * • Carton and Container Labeling
 * • REMS

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov