STN: BL 103850
Proper Name: Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
Manufacturer: GlaxoSmithKline Biologicals
- Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus
December 8, 2016 Approval Letter - Twinrix(PDF - 33KB)
To revise the labeling to address the suspension of Twinrix Prior to use of the product.
April 25, 2016 Approval Letter – TWINRIX(PDF - 32KB)
To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, titled, “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not made with Natural Rubber Latex.”
August 7, 2015 Approval Letter - Twinrix(PDF - 41KB)
To remove all references to the Pregnancy Registry from the package insert.
November 25, 2013 Approval Letter - Twinrix
To include language in the package insert addressing the presence of natural rubber latex in the pre-filled syringe tip cap component.
July 16, 2012 Approval Letter - Twinrix[ARCHIVED]
Updated information regarding instruction on the method of vaccine administration to the Dosage and Administration section of the package insert.
April 12, 2012 Approval Letter - TWINRIX[ARCHIVED]
To revise the package insert to add the text "immediate injection site pain, stinging, and burning sensation" to the Postmarketing Experience Section.
March 12, 2012 Approval Letter - Twinrix[ARCHIVED]
To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.
September 23, 2011 Approval Letter - Twinrix[ARCHIVED]
To rivise the package insert to comply with the Physician Labeling Rule.
September 3, 2010 Approval Letter - Twinrix[ARCHIVED]
Updated the package insert to include the appropriate warnings regarding latex containing components.
December 2, 2009 Approval Letter - Twinrix[ARCHIVED]
Updating the Package Insert to include additional adverse events.
September 16, 2009 Approval Letter - Twinrix[ARCHIVED]
Changes to the package insert regarding the possibility of cracked vials or syringes.
March 28, 2007 Approval Letter - Twinrix[ARCHIVED]
Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus.
May 11, 2001 Approval Letter - Twinrix
For an accelerated dosing schedule of 0, 7, 21-30 days and a month 12 booster dose.