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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:
05/11/2018
Trade Name:
Gilenya
Generic Name or Proper Name (*):
fingolimod
Indications Studied:
Treatment of relapsing forms of multiple sclerosis to include pediatric patients 10 years of age and above
Label Changes Summary:
*Safety and effectiveness for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years were established in one randomized, double-blind clinical study in 215 patients. *Safety and effectiveness in pediatric patients below the age of 10 years have not been established. *Safety in pediatric patients was similar to that observed in adult patients. *In the pediatric study, cases of seizures were reported in 5.6% of Gilenya treated patients and 0.9% of interferon beta-1a treated patients. *It is recommended that pediatric patients if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating Gilenya therapy. *Information on dosing, dosing in pediatric patients with renal impairment, PK parameters, adverse reactions, and clinical trial. *Postmarking study.
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B,P
Sponsor:
Novartis
Pediatric Exclusivity Granted Date:
04/16/2018
NNPS:
FALSE
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