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New Pediatric Labeling Information Database - Detail
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Pediatrics
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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