STN: BL 103647
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Manufacturer: GlaxoSmithKline Biologicals, License #1617
- For active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children 6 weeks to 7 years of age.
April 28, 2016 Approval Letter – INFANRIX(PDF - 32KB)
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.”
November 27, 2013 Approval Letter - Infanrix
To change the product labeling in accordance with the guidance issued on March 11, 2013.
July 16, 2012 Approval Letter - Infanrix[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 - Infanrix[ARCHIVED]
To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.
August 26, 2010 Approval Letter - Infanrix[ARCHIVED]
Revised package insert to include a presentation in a prefilled syringe which has a tip cap which may contain natural rubber latex and plunger which does not contain latex
February 12, 2010 Approval Letter - Infanrix[ARCHIVED]
Revise the Package Insert to add a warning regarding apnea in premature infants.
March 12, 2009 Approval Letter[ARCHIVED]
Revise the package insert to include safety data on the use of INFANRIX following three doses of PEDIARIX.
July 7, 2003 Approval Letter - Infanrix[ARCHIVED]
Fifth dose at 4-6 years of age after 4 prior doses of Infanrix.
Clinical Review - Infanrix SmithKline Beecham Biologicals January 29, 1997 Approval Letter - Infanrix
Primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses of DTaP.
Summary Basis for Regulatory Action - Infanrix(PDF - 4.3MB)