Product Approval Information
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Tradename: Infanrix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Package Insert (PDF - 103 KB) - Approved: July 7, 2003
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Date: July 7, 2003
Indication: Fifth dose at 4-6 years of age after 4 prior doses of Infanrix
July 7, 2003 Approval Letter
Clinical Review
Date: January 29, 1997
Indication: Primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses of DTaP
January 29, 1997 Approval Letter