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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:  03/29/2019
 
Trade Name:  Octaplas
 
Generic Name or Proper Name (*):  Pooled Plasma (Human), Solvent/Detergent Treated*
 
Indications Studied:  Indicated (1) as replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery and liver transplantation and (2) plasma exchange in patients with thrombotic thrombocytopenic purpura
 
Label Changes Summary:  See Package Insert for new information on biologics
 
PREA(P):  P
 
Sponsor:  Octapharma USA, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Pooled human plasma
 
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