Label Changes for:

Synagis (palivizumab) For Intramuscular Administration

August 2008

Changes have been made to the ADVERSE REACTIONS sections of the safety label.


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.


Summary View

Sections Modified

ADVERSE REACTIONS

  • 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...
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