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U.S. Department of Health and Human Services


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Synagis (palivizumab) For Intramuscular Administration August 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 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. Read about the new physician labeling format.

Summary View

Sections Modified


  • Postmarketing Experience
    • Blood and Lymphatic System Disorders
      • Severe Thrombocytopenia (platelet count <50,000/microliter)
    • General Disorders and Administration Site Conditions
      • Injection Site Reactions
    • Immune System Disorders
      • Severe acute hypersensitivity reactions and anaphylaxis...