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Label Changes for:

Gleevec (imatinib mesylate) Tablets

April 2011

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011

 

5 WARNINGS AND PRECAUTIONS

5.4 Hepatotoxicity
5.12 Children and Adolescents
  • ...growth retardation...
5.13 Tumor Lysis syndrome

 

6 ADVERSE REACTIONS

6.13 Postmarketing Experience
  • ...growth retardation...
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