Vaccines, Blood & Biologics
STN: BL 103850
Proper Name: Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
Manufacturer: GlaxoSmithKline Biologicals, License #1617
- 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
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
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
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
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
To rivise the package insert to comply with the Physician Labeling Rule.
September 3, 2010 Approval Letter - Twinrix
Updated the package insert to include the appropriate warnings regarding latex containing components.
December 2, 2009 Approval Letter - Twinrix
Updating the Package Insert to include additional adverse events.
September 16, 2009 Approval Letter - Twinrix
Changes to the package insert regarding the possibility of cracked vials or syringes.
March 28, 2007 Approval Letter - Twinrix
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.