Product Information

• Package Insert - Pediarix (PDF - 137KB)

Supporting Information

• July 16, 2012 Approval Letter - Pediarix
  Updated information regarding instruction on the method of vaccine administration in the Dosage and Administration section of the package insert.
• March 12, 2012 Approval Letter - Pediarix
  To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.
• January 25, 2011 Approval Letter - Pediarix
  Revise labeling to address latex hypersensitivity in the Warnings and Precautions section of the package insert.
• March 5, 2010 Approval Letter - Pediarix
  Revised package insert to include the results from a postmarketing safety surveillance study that evaluated the risk of all seizures (with or without fever).
• February 12, 2010 Approval Letter - Pediarix
  Revise the Package Insert to add a warning regarding apnea in premature infants and to update the subsection on postmarketing adverse events.
• December 13, 2002 Approval Letter - Pediarix
  Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3.
• Clinical Review - November 25, 2002 - Pediarix
• Clinical Review - November 12, 2001 - Pediarix (PDF - 943KB)
• Summary Basis for Regulatory Action - Pediarix (PDF - 76KB)

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