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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:
12/01/2009
Trade Name:
Patanase
Generic Name or Proper Name (*):
olopatadine
Indications Studied:
Seasonal allergic rhinitis
Label Changes Summary:
Expanded age range down to 6 years; previously approved for use in 12 years and older Safety and effectiveness have not been established in < 6 years of age The incidence of epistaxis (nosebleed) was higher in children 6 -11 years of age compared to the adult and adolescent population Information on clinical trials, adverse reactions, and new one spray per nostril twice daily dosing in 6-11 years
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Alcon
Pediatric Exclusivity Granted Date:
08/12/2009
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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