August 26, 2010 Approval Letter - Infanrix 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
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.
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Tradename: Infanrix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indications:
Product Information
Supporting Documents
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
Revise the Package Insert to add a warning regarding apnea in premature infants.
Revise the package insert to include safety data on the use of INFANRIX following three doses of PEDIARIX.
Fifth dose at 4-6 years of age after 4 prior doses of Infanrix.
Primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses of DTaP.