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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:  03/15/2013
 
Trade Name:  Recothrom
 
Generic Name or Proper Name (*):  Thrombin, topical (Recombinant) *
 
Indications Studied:  Aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Zymogenetics, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Topical thrombin
 
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