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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:  09/12/2018
 
Trade Name:  Actemra
 
Generic Name or Proper Name (*):  tocilizumab
 
Indications Studied:  Systemic juvenile idiopathic arthritis in pediatric patients 2 through 17 years – Subcutaneous
 
Label Changes Summary:  *Approved new subcutaneous dosing and administration for the active systemic juvenile idiopathic arthritis in patients 2 years of age and older. *Information on dosing, clinical trials. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Genentech/Hoffmann-La Roche
 
Pediatric Exclusivity Granted Date:  07/18/2018
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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