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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:  06/07/2017
 
Trade Name:  FIBRYNA
 
Generic Name or Proper Name (*):  Fibrinogen (Human)*
 
Indications Studied:  Treatment of acute bleeding episodes in adults and adolescents = 12 years of age with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia
 
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
 
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