Regulatory PathRegulatory requirements compared

Active substance

Hepatitis b surface antigen

Open in the medicines table

EMA European Union — centrally authorised medicines

Fendrix GlaxoSmithKline Biologicals S.A. · Authorised · authorised 2 Feb 2005 · ATC J07BC01

Therapeutic indication (EMA)

Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).

Heplisav B Dynavax GmbH · Authorised · authorised 18 Feb 2021 · ATC J07BC01

Therapeutic indication (EMA)

Heplisav B is indicated for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The use of Heplisav B should be in accordance with official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with Heplisav B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

PreHevbri VBI Vaccines B.V. · Withdrawn · authorised 25 Apr 2022 · ATC J07BC01

Therapeutic indication (EMA)

PreHevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ENGERIX-B0248702010 MCG / 0.5 MLSUSPENSION · INTRAMUSCULARGLAXOSMITHKLINE INC
ENGERIX-B0248703920 MCG / 1 MLSUSPENSION · INTRAMUSCULARGLAXOSMITHKLINE INC
RECOMBIVAX HB0224597740 MCG / MLSUSPENSION · INTRAMUSCULARMERCK CANADA INC
RECOMBIVAX HB025614765 MCG / 0.5 MLSOLUTION · INTRAMUSCULARMERCK CANADA INC
RECOMBIVAX HB0256148410 MCG / 1 MLSOLUTION · INTRAMUSCULARMERCK CANADA INC

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.