Product Approval Information
Proper Name: Hepatitis A Vaccine, Inactivated
Tradename: Havrix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Package Insert (PDF - 167 KB) - Approved: March 26, 2008
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Date: March 26, 2008
Efficacy Supplement: To include coadministration of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Prevnar®) with Hepatitis A Vaccine Inactivated (Havrix®) for children in the second year of life
March 26, 2008 Approval Letter
Date: February 21, 2006
Package insert labeling changes regarding geriatric use
February 21, 2006 Approval Letter
Date: October 17, 2005
Indication: To support lowering the age indication for Havrix from two years to 12 months of age
October 17, 2005 Approval Letter
Clinical Review (PDF - 772 KB)