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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:
02/26/2003
Trade Name:
Pulmicort
Generic Name or Proper Name (*):
budesonide
Indications Studied:
Maintenance and Prophylaxis of Asthma
Label Changes Summary:
Safety information in pediatric patients 6 to 12 months of age A dose dependent effect on growth was observed in the 12-week trial which supports the finding that the use of Pulmicort Respules in infants 6 to 12 months of age may result in systemic effects and is consistent with the findings of growth suppression in other studies with inhaled corticosteroids Pneumonia was observed more frequently in patients treated with Pulmicort Respules than in patients treated with placebo
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
11/12/2002
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic
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