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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:
01/30/2015
Trade Name:
Pazeo
Generic Name or Proper Name (*):
olopatadine hydrochloride
Indications Studied:
Ocular itching associated with allergic conjunctivitis
Label Changes Summary:
*Safety and effectiveness have been established in pediatric patients 2 years and older. Use in these pediatric patients is supported by evidence from adequate and well-controlled studies in adults and an adequate and well controlled study evaluating the safety in pediatric and adult patients *New formulation
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Alcon
Therapeutic Category:
Antihistamine, topical
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