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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:
09/01/2004
Trade Name:
Clarinex
Generic Name or Proper Name (*):
desloratadine
Indications Studied:
Seasonal and perennial allergic rhinitis, and the symptomatic relief of pruritus, and hives
Label Changes Summary:
Indicated for seasonal allergic rhinitis down to 2 years of age. Extended age range down to 6 months for perennial allergic rhinitis and chronic idiopathic urticaria Safety and effectiveness of tablets or syrup has not been established in pediatric patients less than 6 months of age Information on dose, PK parameters, and AE profile in pediatric patients 6 months - 11 years of age
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Schering
Pediatric Exclusivity Granted Date:
02/12/2003
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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