Twinrix Adult

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). 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 05/02/2018

Authorisation details

Product details
Name
Twinrix Adult
Agency product number
EMEA/H/C/000112
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
19
Date of issue of marketing authorisation valid throughout the European Union
19/09/1996
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

26/10/2017 Twinrix Adult - EMEA/H/C/000112 - N/0122

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

Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.

Assessment history

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