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.
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)