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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  12/17/2014
 
Trade Name:  QNASL
 
Generic Name or Proper Name (*):  beclomethasone dipropionate
 
Indications Studied:  Treatment of the nasal symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis
 
Label Changes Summary:  *Indication extended to pediatric patients aged 4 years and older. *The efficacy and safety of QNASL Nasal Aerosol have been established in 2 clinical trials of 2 to 12 weeks duration in total of 1255 pediatric patients 4 to 11 years of age with symptoms of seasonal or perennial allergic rhinitis. *The local nasal effects in children aged 4-11 years were similar to those reported in patients 12 years of age and older in clinical trials *Dosing information for children aged 4-11 years *The safety and effectiveness of QNASL Nasal Aerosol in children younger than 4 years of age have not been established
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Teva
 
Therapeutic Category:  Antiallergy
 
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