Product Information

• Package Insert - Pneumovax 23 (PDF - 160KB)
• Patient Information-Pneumovax 23 (PDF - 36KB)

Supporting Documents

• October 27, 2011 Approval Letter - PNEUMOVAX 23
  To allow the addition of information regarding concomitant administration with ZOSTAVAX® to the labeling and revise the labeling to comply with the Physician’s Labeling Rule (PLR).
• Summary Basis for Regulatory Action - Pneumovax 23 - October 25, 2011 (PDF - 66KB)
• January 21, 2011 Approval Letter -Pneumovax 23
  Revised with changes to the package insert to update the Geriatric Use and the Adverse Reactions sections.
• June 5, 2009 Approval Letter - PNEUMOVAX®23
  Revision to Package Insert: To include the addition of language to update the package insert to reference current ACIP recommendations.
• January 16, 2009 Approval Letter - Pneumovax 23
  Revisions to Package Insert: Revisions include the addition of language to the Adverse Reactions section indicating that certain systemic events may be associated with local injection site reactions and modified text under ....
• August 6, 2008 Approval Letter - Pneumovax 23
  Labeling Change: To include the new term “Leukocytosis” in the Adverse Reactions section of the package insert.
• Summary for Basis of Approval - PNEUMOVAX-23 - Pneumococcal Vaccine, PolyValent, June 30, 1983 (PDF - 274KB)

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