Vaccines, Blood & Biologics
STN: BL 103475
Proper Name: Hepatitis A Vaccine, Inactivated
Manufacturer: GlaxoSmithKline Biologicals, License #1617
- For active immunization against disease caused by hepatitis A virus (HAV) for persons ≥12 months of age.
- November 25, 2013 Approval Letter - Havrix [ARCHIVED]
To include language in the package insert addressing the presence of natural rubber latex in the pre-filled syringe tip cap component.
- June 11, 2013 Approval Letter-HAVRIX [ARCHIVED]
To include a revision of the United States prescription information’s (USPI).
- July 16, 2012 Approval Letter - Havrix [ARCHIVED]
Updated information regarding instruction on the method of vaccine administration to the Dosage and Administration section of the package insert.
- March 12, 2012 Approval LEtter - HAVRIX [ARCHIVED]
To the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.
- July 21, 2011 Summary Basis for Regulatory Action - Havrix (PDF - 188KB)
- July 22, 2011 Approval Letter - Havrix [ARCHIVED]
To include immunogenicity and safety data to support concomitant administration of Havrix with M-M-R®II and VARIVAX® among children 12-15 months of age.
- Dear Healthcare Provider Letter: Information Re: Havrix (Hepatitis A Vaccine) Tip Caps Of The Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions In Latex Sensitive Individuals
- August 23, 2010 Approval Letter - Havrix [ARCHIVED]
Revisd the Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.
- June 2, 2010 Approval Letter - Havrix [ARCHIVED]
Revised the package insert to include new National Drug Code (NDC) numbers for pre-filled syringes that contain no latex and a statement regarding the availability of pre-filled syringes with and without latex containing components.
- December 14, 2009 Approval Letter - Havrix [ARCHIVED]
To update the package insert to include additional adverse events.
- October 1, 2009 Approval Letter [ARCHIVED]
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 [ARCHIVED]
Changes to the package insert regarding the possibility of cracked vials or syringes.
- March 26, 2008 Approval Letter - Havrix [ARCHIVED]
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 [ARCHIVED]
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 - Havrix (PDF - 772KB)
- Summary Basis for Regulatory Action - Havrix (PDF - 7.2MB)