Fendrix

hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Fendrix?

Fendrix is a vaccine, which is available as a suspension for injection. It contains parts of the hepatitis B virus as the active substance.

What is Fendrix used for?

Fendrix is used to protect patients with kidney problems against hepatitis B. It can be used in patients from the age of 15 years, including patients needing haemodialysis (a blood clearance technique).

The medicine can only be obtained with a prescription.

How is Fendrix used?

The recommended vaccination schedule for Fendrix is four doses. There should be a gap of one month between the first and second, and between the second and third injections. The fourth injection is given four months after the third. It is recommended that individuals who receive the first dose should complete the course with Fendrix. The vaccine is injected into the muscle at the top of the arm.

A booster dose of Fendrix may be given, according to official recommendations.

How does Fendrix work?

Fendrix is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Fendrix contains small amounts of the ‘surface antigen’ (proteins from the surface) of the hepatitis B virus. When a patient is given the vaccine, the immune system recognises the surface antigens as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to make antibodies more quickly when it is exposed to the hepatitis B virus. The antibodies will help to protect against the disease caused by the virus.

The surface antigens 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 substance in Fendrix has been available in other vaccines authorised in the European Union (EU) for a number of years, including Engerix-B, Ambirix, Twinrix, Tritanrix-HepB and Infanrix-HepB. In Fendrix, it is used with an ‘adjuvant system’ which contains ‘MPL’, a purified fat from bacteria, and an aluminium compound. This system enhances the response of the immune system, which can help when vaccines are used in patients who may have a lower response, such as those with kidney problems.

How has Fendrix been studied?

Because the active substance in Fendrix has been available in the EU in other vaccines, some of the data used to support the use of the other vaccines were used to support the use of Fendrix.

Fendrix has been studied in one main study involving 165 patients aged 15 years and above who had kidney disease and needed haemodialysis. Fendrix was compared with Engerix-B (another hepatitis B vaccine) used as a double dose. The main measure of effectiveness was the proportion of patients who developed protective levels of antibodies to the hepatitis B virus.

The company also presented data on the use of Fendrix in liver transplant patients, but it withdrew the application for the use of Fendrix in these patients during the assessment.

What benefit has Fendrix shown during the studies?

Fendrix was as effective as a double dose of the comparator vaccine. One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against hepatitis B, compared with 84% of those receiving the comparator.

The effect of Fendrix lasted longer than that of the comparator vaccine: 80% of the patients receiving Fendrix maintained protective levels of antibody for up to three years, compared with 51% of those receiving the comparator.

What is the risk associated with Fendrix?

The most common side effects with Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling at the injection site and fatigue (tiredness). For the full list of side effects reported with Fendrix, see the package leaflet.

Fendrix must not be used in people who are hypersensitive (allergic) to the active substance or any of the other ingredients, have had an allergic reaction after being given a hepatitis B vaccine. Fendrix should not be given to patients with a severe sudden fever.

Why has Fendrix been approved?

The CHMP decided that Fendrix’s benefits are greater than its risks for active immunisation against hepatitis B virus infection caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients), from the age of 15 years onwards. The Committee recommended that Fendrix be given marketing authorisation.

Other information about Fendrix

The European Commission granted a marketing authorisation valid throughout the European Union for Fendrix on 2 February 2005.

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

Name Language First published Last updated
Fendrix : EPAR - Summary for the public BG = bălgarski 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public ES = español 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public CS = čeština 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public DA = dansk 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public DE = Deutsch 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public ET = eesti keel 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public EL = elliniká 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public EN = English 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public FR = français 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public IT = italiano 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public LV = latviešu valoda 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public LT = lietuvių kalba 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public HU = magyar 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public MT = Malti 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public NL = Nederlands 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public PL = polski 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public PT = português 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public RO = română 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public SK = slovenčina 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public SL = slovenščina 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public FI = suomi 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public SV = svenska 2008-07-09 2014-12-22
Fendrix : EPAR - Summary for the public HR = Hrvatski 2008-07-09 2014-12-22

This EPAR was last updated on 10/12/2015 .

Authorisation details

Product details

Product details for Fendrix
NameFendrix
Agency product numberEMEA/H/C/000550
Active substance

hepatitis B surface antigen

International non-proprietary name (INN) or common name

hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

Therapeutic area Hepatitis BImmunization
Anatomical therapeutic chemical (ATC) code J07BC01

Publication details

Publication details for Fendrix
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.

Revision9
Date of issue of marketing authorisation valid throughout the European Union02/02/2005

Contact address:

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

Product information

Product information

12/11/2015  Fendrix -EMEA/H/C/000550 -N/0048

Name Language First published Last updated
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10
Fendrix : EPAR - Product Information HR = Hrvatski 2009-04-07 2015-12-10

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
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02
Fendrix : EPAR - All Authorised presentations HR = Hrvatski 2005-12-21 2014-05-02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

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).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Fendrix : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-04-07 2015-12-10

Initial marketing-authorisation documents

Name Language First published Last updated
Fendrix : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-12-21  
Fendrix : EPAR - Scientific Discussion HR = Hrvatski 2005-12-21  

Authorised

This medicine is approved for use in the European Union