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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:
08/21/2009
Trade Name:
Xyzal
Generic Name or Proper Name (*):
levocetirizine dihydrochloride
Indications Studied:
Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older
Label Changes Summary:
Expanded age range for CIU down to 6 months; previously approved for use in 12 years and older Expanded age range for PAR down to 6 months; previously approved for use in 6 years and older Expanded age range for SAR down to 2 years; previously approved for use in 6 years and older Pediatric use is supported by evidence from studies in adults with additional safety and PK data in pediatrics Patient population altered
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
UCB
Pediatric Exclusivity Granted Date:
08/25/2009
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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