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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:
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]
PREA(P):
P
Sponsor:
Bristol-Myers Squibb
NNPS:
FALSE
Therapeutic Category:
Antineoplastic
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