Quintanrix

RSS

diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Quintanrix has been withdrawn at the request of the marketing authorisation holder

This EPAR was last updated on 10/09/2008

Authorisation details

Product details
Name
Quintanrix
Agency product number
EMEA/H/C/000556
Active substance
  • Diphtheria toxoid
  • tetanus toxoid
  • inactivated Bordetella pertussis
  • hepatitis B surface antigen (rDNA)
  • Haemophilus influenzae type b polysaccharide
International non-proprietary name (INN) or common name
diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)
Therapeutic area (MeSH)
  • Hepatitis B
  • Tetanus
  • Immunization
  • Meningitis, Haemophilus
  • Whooping Cough
  • Diphtheria
Anatomical therapeutic chemical (ATC) code
J07CA10
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
17/02/2005
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

11/12/2007 Quintanrix - EMEA/H/C/000556 - II/0008

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

Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.
The use of Quintanrix should be determined on the basis of official recommendations.

Assessment history

How useful was this page?

Add your rating