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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:  08/02/2018
 
Trade Name:  PANZYGA
 
Generic Name or Proper Name (*):  Immune Globulin Intravenous, human-ifas*
 
Indications Studied:  Indicated for 1) Primary humoral immunodeficiency (PI) in patients 2 years of age and older 2) Chronic immune thrombocytopenic purpura (ITP) in adults
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Octapharma Pharmazeutika Produktionsges.m.b.H.
 
NNPS:  FALSE
 
Therapeutic Category:  Immunologic agent
 
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