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 18, 2018 Approval Letter - TWINRIX
- December 8, 2016 Approval Letter - Twinrix
To revise the labeling to address the suspension of Twinrix Prior to use of the product.
- April 25, 2016 Approval Letter - TWINRIX
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
To remove all references to the Pregnancy Registry from the package insert.
- Supporting Documents older than three years - TWINRIX