Ambirix

RSS

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

Authorised
This medicine is authorised for use in the European Union.

Overview

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 27/10/2017

Authorisation details

Product details
Name
Ambirix
Agency product number
EMEA/H/C/000426
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
J07BC20
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
30/08/2002
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

27/10/2017 Ambirix - EMEA/H/C/000426 - N/0088

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

VACCINES

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.

Therefore:

  • 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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