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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:
12/10/2004
Trade Name:
Agrylin
Generic Name or Proper Name (*):
anagrelide
Indications Studied:
Myeloproliferative disorders
Label Changes Summary:
An open-label study evaluated PK/PD but not efficacy. Information on PK/PD profile, dosing, AEs, and safety in patients > 6 years to 17 years No overall difference in dosing and safety were observed between pediatric and adult patients Established recommended starting dose based on limited data. Dosage should be adjusted to the lowest effective dosage
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Shire
Pediatric Exclusivity Granted Date:
05/25/2004
NNPS:
FALSE'
Therapeutic Category:
Hematology/Coagulation
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