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Vaccines, Blood & Biologics
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Resources for You
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Pneumovax 23 - Pneumococcal Vaccine, Polyvalent
Proper Name: Pneumococcal Vaccine, Polyvalent
Tradename: Pneumovax 23
Manufacturer: Merck & Co., Inc, License #0002
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Supporting Documents
- 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 (PDF - 306KB)
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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