Fendrix

RSS

hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

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

Overview

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).

This EPAR was last updated on 24/11/2017

Authorisation details

Product details
Name
Fendrix
Agency product number
EMEA/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 (MeSH)
  • Hepatitis B
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BC01
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
01/02/2005
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

26/10/2017 Fendrix - EMEA/H/C/000550 - N/0060

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

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

How useful was this page?

Add your rating