hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Ambirix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ambirix.

This EPAR was last updated on 24/05/2023

Authorisation details

Product details
Agency product number
Active substance
  • hepatitis A virus (inactivated)
  • hepatitis B surface antigen
International non-proprietary name (INN) or common name
hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Therapeutic area (MeSH)
  • Hepatitis B
  • Hepatitis A
  • Immunization
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Rue de l'Institut, 89
B-1330 Rixensart

Product information

26/04/2023 Ambirix - EMEA/H/C/000426 - WS2365

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-A and hepatitis-B infection.

Protection against hepatitis-B infections may not be obtained until after the second dose.


  • Ambirix should be used only when there is a relatively low risk of hepatitis-B infection during the vaccination course;
  • it is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.

Assessment history

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