Twinrix Paediatric

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 22/01/2019

Authorisation details

Product details
Name
Twinrix Paediatric
Agency product number
EMEA/H/C/000129
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)
  • Immunization
  • Hepatitis B
  • Hepatitis A
Anatomical therapeutic chemical (ATC) code
J07BC20
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
10/02/1997
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

24/09/2018 Twinrix Paediatric - EMEA/H/C/000129 - IG/0960

Contents

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 Paediatric is indicated for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis-A and hepatitis-B infection.

Assessment history

How useful was this page?

Add your rating