Proper Name: Hepatitis B Vaccine (Recombinant)
Manufacturer: GlaxoSmithKline Biologicals
Indications: ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
- December 19, 2018 Approval Letter - Engerix-B
- April 28, 2016 Approval Letter - ENGERIX-B
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.”
- September 15, 2015 Approval Letter - Engerix_B
To include safety and immunogenicity data for adults with type 2 diabetes mellitus in the Engerix-B Package Insert Prescribing Information.
- September 11, 2015 Summary Basis for Regulatory Action - Engerix - B
- Supporting Documents older than three years-ENGERIX-B