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U.S. Department of Health and Human Services

Safety

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Invega (paliperidone) Extended-Release Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

ADVERSE REACTIONS

  • Extrapyramidal Symptoms (EPS)
    • Dystonia - Class Effect

Label approved 05/16/2008 is not available on Drugs@FDA

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