Product Information

• Package Insert - Kinrix (PDF - 148KB)

Supporting Documents

• July 16, 2012 Approval Letter - Kinrix
  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 - Kinrix
  To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information
• January 20, 2011 Approval Letter - Kinrix
  Revise the Package to address the presence of latex in the tip caps of the pre-filled syringes.
• May 19, 2010 Approval Letter - Kinrix
  Revised the package insert to include a new presentation of a single-dose prefilled syringe that does not contain latex.
• October 8, 2009 Approval Letter - Kinrix
  Changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist.
• June 24, 2008 Approval Letter - Kinrix
  Indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series.
• Summary Basis for Regulatory Action - KINRIX
• Approval History, Letters, Reviews, and Related Documents - KINRIX

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