Quintanrix
diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)
Table of contents
Overview
The marketing authorisation for Quintanrix has been withdrawn at the request of the marketing authorisation holder
Authorisation details
| Product details | |
|---|---|
| Name |
Quintanrix
|
| Agency product number |
EMEA/H/C/000556
|
| Active substance |
|
| 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) |
|
| 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
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.