Vaccines, Blood & Biologics
?
-
Havrix
STN: BL 103475
Proper Name: Hepatitis A Vaccine, Inactivated
Tradename: Havrix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indication:
- For active immunization against disease caused by hepatitis A virus (HAV) for persons ≥12 months of age.
-
Supporting Documents
July 16, 2012 Approval Letter - Havrix
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
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
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
Revisd the Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.June 2, 2010 Approval Letter - Havrix
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
To update the package insert to include additional adverse events.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 - Havrix (PDF - 772KB)Summary Basis for Regulatory Action - Havrix (PDF - 7.2MB)
-
Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
-
-