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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:  03/23/2012
 
Trade Name:  QNASL
 
Generic Name or Proper Name (*):  beclomethasone dipropionate
 
Indications Studied:  Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis
 
Label Changes Summary:  "Safety and effectiveness in children 12 years and older have been established "Safety and effectiveness in <12 years have not been established "Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QNASL Nasal Aerosol "The potential for QNASL Nasal Aerosol to cause reduction in growth velocity in susceptible patients or when given at higher than recommended dosages cannot be ruled out "Information on safety, adverse events and clinical trials "New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Teva
 
Therapeutic Category:  Anti-inflammatory, topical
 
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