STN: BL 125260
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
Manufacturer: GlaxoSmithKline Biologicals
- Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose.
April 25, 2016 Approval Letter - Kinrix(PDF - 27KB)
To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, titled, “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.
July 23, 2014 Approval Letter - Kinrix
To revise the package insert to include safety and immunogenicity data to support co-administration of Kinrix with varicella virus vaccine and to update the pharmacovigilance plan.
July 01, 2014 Summary Basis for Regulatory Action - KINRIX(PDF - 94KB) November 27, 2013 Approval Letter - Kinrix - ARCHIVED
To change the product labeling in accordance with the guidance issued on March 11, 2013.
July 16, 2012 Approval Letter - Kinrix - ARCHIVED
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 - ARCHIVED
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 - ARCHIVED
Revise the Package to address the presence of latex in the tip caps of the pre-filled syringes.
May 19, 2010 Approval Letter - Kinrix - ARCHIVED
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 - ARCHIVED
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[ARCHIVED]