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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:  04/18/2019
 
Trade Name:  Opdivo
 
Generic Name or Proper Name (*):  nivolumab
 
Indications Studied:  Treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC)
 
Label Changes Summary:  *New recommended dosage regimens for nivolumab for the treatment of patients with MSI-H or dMMR mCRC in adults and pediatric patients. *Additionally, a modification of the recommended dosage regimen for nivolumab in adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC for OPDIVO 240 mg intravenously over 30 minutes every 2 weeks until disease progression or unacceptable toxicity, to limit this dosage regimen to adult and pediatric patients weighing 40 kg or more. *Postmarketing study.
 
Product Labeling:  [INVALID]  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bristol-Myers Squibb
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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