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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:
09/14/2015
Trade Name:
Velcade
Generic Name or Proper Name (*):
bortezomib
Indications Studied:
Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
Label Changes Summary:
*Effectiveness in pediatric patients with relapsed pre-B ALL has not been established. *The activity and safety of Velcade in combination with intensive reinduction chemotherapy was evaluated in pediatric and young adult patients with lymphoid malignancies. There were 140 patients with ALL or LL enrolled and evaluated for safety. *No new safety concerns were observed
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Millennium Pharmaceuticals, Inc.
NNPS:
FALSE
Therapeutic Category:
Antineoplastic
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