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Proper Name: Hepatitis A Vaccine, Inactivated
Tradename: Havrix
Manufacturer: GlaxoSmithKline Biologicals, License #1617

Indication:

To support lowering the age indication for Havrix from two years to 12 months of age.

October 1, 2009 Approval Letter
This fulfills your commitment to assess the safety and immunogenicity of concurrent administration of HAVRIX® (720 EL.U/0.5 mL dose) with Infanrix and ActHIB in healthy children 12 to 15 months of age.
September 17, 2009 Approval Letter - Havrix
Changes to the package insert regarding the possibility of cracked vials or syringes.
March 26, 2008 Approval Letter - Havrix
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.
February 21, 2006 Approval Letter - Havrix
Package insert labeling changes regarding geriatric use.
October 17, 2005 Approval Letter - Havrix
To support lowering the age indication for Havrix from two years to 12 months of age.
Clinical Review - Hepatitis A Vaccine, Inactivated (PDF - 772KB)
Summary for Basis of Approval - Hepatitis A Vaccine, Inactivated (PDF - 2341KB)