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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:  10/13/2006
 
Trade Name:  Tirosint capsules
 
Generic Name or Proper Name (*):  levothyroxine
 
Indications Studied:  Replacement or supplemental therapy in hypothyroidism; treatment or prevention of euthyroid goiters
 
Label Changes Summary:  * Contraindicated in infants, small children, or any child who may be unable to swallow a capsule. * Dosing information provided * Information to monitor disease provided * No clinical studies submitted * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Institute Biochimique SA
 
NNPS:  FALSE
 
Therapeutic Category:  Thyroid replacement
 
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