Vaccines, Blood & Biologics
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Engerix-B
STN: 103239
Proper Name: Hepatitis B Vaccine (Recombinant)
Tradename: Engerix-B
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indications: ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
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Supporting Documents
July 16, 2012 Approval Letter - Engerix-B
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- ENGERIX-B
To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing InformationFebruary 27, 2012 Approval Letter - Engerix-B
To include updated information regarding multiple sclerosis in the Warnings and Precautions section of the package insert.December 23, 2010 Approval Letter - Engerix-B
Revisions to the package insert in order to comply with the Physician Labeling Rule.Dear Healthcare Provider Letter: Information Re: Engerix-B (Hepatitis B Vaccine (Recombinant)) 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 - Engerix-B
Revised Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.June 2, 2010 Approval Letter - Engerix
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.May 5, 2010 Approval Letter - Engerix-B
Updated: The Prescribing Information to include the addition of new adverse events and a warning regarding apnea in premature infants.December 23, 2009 Approval Letter - Engerix-B
To update the Package Insert to include the addition of text to visually inspect vials or syringes for cracks prior to administration.October 15, 2009 Approval Letter - Engerix-B
Introduction of a 10 pack carton of Engerix-B 10 mcg Pre-Filled Syringes for Pediatric/Adolescent use, and accompanying Package Insert.January 30, 2007 Approval Letter - Engerix-B
Thimerosal-free formulation.March 28, 2000 Approval Letter - Engerix-B
Preservative-free pediatric monodose presentation.July 7, 1998 Approval Letter - Engerix-B
In individuals (adults) with chronic Hepatitis C infection.Summary for Basis of Approval - Engerix-B (PDF - 649KB)Clinical Review - Engerix-B (PDF - 296KB)
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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
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