Ambirix

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

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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.

What is Ambirix?

Ambirix is a vaccine that contains inactivated (killed) hepatitis-A virus and parts of the hepatitis-B virus as active substances. It is available as a suspension for injection.

What is Ambirix used for?

Ambirix is used to protect against hepatitis A and hepatitis B (diseases that affect the liver) in children between one and 15 years of age who are not already immune to these two diseases.

Ambirix is used as a two-dose schedule and protection against hepatitis B may not be obtained until after the second dose. Because of this, Ambirix should only be used when there is a low risk of hepatitis-B infection during the vaccination course, and when it is certain that the two-dose vaccination course can be completed.

The medicine can only be obtained with a prescription.

How is Ambirix used?

Ambirix is given as two injections six to 12 months apart into the muscle of the upper arm, or into the thigh in very young children. Individuals who receive the first injection should complete the course with Ambirix.

Where a booster dose of hepatitis A or B is desired, Ambirix, or a separate hepatitis-A or -B vaccine may be given.

How does Ambirix work?

Ambirix is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Ambirix contains small amounts of inactivated hepatitis-A viruses and the ‘surface antigen’ (proteins from the surface) of the hepatitis B virus. When a child is given the vaccine, the immune system recognises the viruses and surface antigens as ‘foreign’ and makes antibodies against them., The immune system will then be able to make antibodies more quickly when exposed to the viruses again. The antibodies will help to protect against the diseases caused by these viruses.

The vaccine is ‘adsorbed’. This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response. The surface antigens of the hepatitis-B virus are produced by a method known as ‘recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.

The active substances in Ambirix have been available in other vaccines authorised in the European Union (EU): Ambirix contains the same ingredients as Twinrix Adult, which has been authorised since 1996, and as Twinrix Paediatric, which has been authorised since 1997. The three vaccines are used to protect against the same diseases, but Twinrix Adult and Twinrix Paediatric are given as a three-dose schedule.

How has Ambirix been studied?

Because Ambirix and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Ambirix.

Three main studies of Ambirix were carried out in a total of 615 children from one year of age. All of the children received two doses of Ambirix six months apart. Two of the studies compared Ambirix with other vaccines against hepatitis A and B. The main measure of effectiveness was the proportion of vaccinated children who developed protective levels of antibodies one month after the last injection.

An additional study in 208 children compared the vaccine’s effectiveness when a six-month or a 12-month interval was used between the two injections.

What benefit has Ambirix shown during the studies?

Ambirix led to the development of protective levels of antibodies against hepatitis A and B in between 98 and 100% of the vaccinated children one month after the last injection. These levels were maintained in over 93% of the children after two years. Ambirix was as effective as other vaccines against hepatitis A and B once the full vaccination course had been completed. However, full protection against hepatitis B did not develop until the second dose of Ambirix had been given.

The additional study showed that the levels of protection with Ambirix were similar with a six- and a 12-month gap between injections.

What is the risk associated with Ambirix?

The most common side effects with Ambirix (seen in more than one in 10 doses of the vaccine) are loss of appetite, irritability, headache, fatigue (tiredness) and pain and redness at the site of injection. For the full list of all side effects reported with Ambirix, see the package leaflet.

Ambirix should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic). It must also not be used in people who have had an allergic reaction after being given hepatitis-A or hepatitis-B vaccines.

Vaccination with Ambirix should be postponed in patients with a severe sudden fever. The vaccine should never be injected into a vein.

Why has Ambirix been approved?

The CHMP decided that Ambirix’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Ambirix

The European Commission granted a marketing authorisation valid throughout the EU for Ambirix to GlaxoSmithKline Biologicals s.a. on 30 August 2002. After five years, the marketing authorisation was renewed for a further five years.

For more information about treatment with Ambirix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Ambirix : EPAR - Summary for the public BG = bălgarski 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public ES = español 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public CS = čeština 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public DA = dansk 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public DE = Deutsch 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public ET = eesti keel 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public EL = elliniká 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public EN = English 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public FR = français 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public IT = italiano 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public LV = latviešu valoda 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public LT = lietuvių kalba 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public HU = magyar 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public MT = Malti 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public NL = Nederlands 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public PL = polski 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public PT = português 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public RO = română 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public SK = slovenčina 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public SL = slovenščina 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public FI = suomi 15/04/2008 17/01/2011
Ambirix : EPAR - Summary for the public SV = svenska 15/04/2008 17/01/2011

This EPAR was last updated on 24/04/2014 .

Authorisation details

Product details

Product details for Ambirix
NameAmbirix
Agency product numberEMEA/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 Hepatitis BHepatitis AImmunization
Anatomical therapeutic chemical (ATC) code J07BC20

Publication details

Publication details for Ambirix
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.

Revision10
Date of issue of marketing authorisation valid throughout the European Union30/08/2002

Contact address:

GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

Product information

12/12/2013  Ambirix -EMEA/H/C/000426 -N/0053

Name Language First published Last updated
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014
Ambirix : EPAR - Product Information SV = svenska 24/09/2007 24/04/2014

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.


Name Language First published Last updated
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014
Ambirix : EPAR - All Authorised presentations SV = svenska 23/11/2005 24/04/2014

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Ambirix : EPAR - Procedural steps taken before authorisation SV = svenska 23/11/2005  
Ambirix : EPAR - Scientific Discussion SV = svenska 23/11/2005  

Authorised

This medicine is approved for use in the European Union