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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  10/18/2019
 
Trade Name:  Ultomiris
 
Generic Name or Proper Name (*):  ravulizumab-cwvz
 
Indications Studied:  Treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
 
Label Changes Summary:  *Safety and effectiveness for the treatment of aHUS have been established in pediatric patients aged one month and older. *Use for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety, and efficacy data in pediatric patients aged 10 months to <17 years. *Safety and efficacy for the treatment of paroxysmal nocturnal hemoglobinuria in pediatric patients have not been established. *Information on dosing recommendations and considerations, adverse reactions, and clinical trial. *New indication.
 
PREA(P):  P
 
Sponsor:  Alexion Pharmaceuticals, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Humanized monoclonal antibody
 
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