-
Vaccines, Blood & Biologics
-
Resources for You
-
-
Infanrix
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Tradename: Infanrix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indications:
- 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.
-
Supporting Documents
- February 12, 2010 Approval Letter - Infanrix
Revise the Package Insert to add a warning regarding apnea in premature infants. - March 12, 2009 Approval Letter
Revise the package insert to include safety data on the use of INFANRIX following three doses of PEDIARIX. - July 7, 2003 Approval Letter - Infanrix
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.
-
-
-