Product Approval Information
Proper Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Tradename: Boostrix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Package Insert (PDF - 202 KB) - December, 2008
Date: December 4, 2008
Supplement BLA: To include single booster dose in adults 19-64 years of age for active immunization against tetanus, diphtheria, and pertussis.
December 4, 2008 Approval Letter
Date: December 29, 2005
Package Insert Revision: Include addition of clinical safety information to the package insert
December 29, 2005 Approval Letter
Date: May 3, 2005
Indication: Booster immunization against tetanus, diphtheria and pertussis as a single dose in adolescents 10-18 years of age
May 3, 2005 Approval Letter
First Combination Vaccine Approved to Help Protect Adolescents Against Whooping Cough - May 3, 2005