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Vaccines, Blood & Biologics
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Resources for You
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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 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.
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Supporting Documents
- 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. - Summary Basis of Approval - Infanrix (PDF - 1815KB)
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