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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:
05/06/2011
Trade Name:
Plavix
Generic Name or Proper Name (*):
clopidogrel bisulfate
Indications Studied:
Reduction of the incidence of thrombosis in children with systemic to pulmonary artery shunts for palliation of cyanotic congenital heart disease
Label Changes Summary:
Safety and effectiveness in pediatric populations have not been establishedA randomized, placebo-controlled trial did not demonstrate a clinical benefit in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt.
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Sanofi Aventis
Pediatric Exclusivity Granted Date:
01/20/2011
NNPS:
FALSE'
Therapeutic Category:
Platelet inhibitor
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