Product Approval Information
Proper Name: Pneumococcal Vaccine, Polyvalent
Tradename: Pneumovax 23
Manufacturer: Merck & Co., Inc, License #0002
Package Insert (PDF - 91 KB) - Approved: January 2009
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Date: January 16, 2009
Revisions to Package Insert: To 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 the heading, Pediatric Use, in the Precautions section.
January 16, 2009 Approval Letter
Date: August 6, 2008
Labeling Change: To include the new term “Leukocytosis” in the Adverse Reactions section of the package insert
August 6, 2008 Approval Letter