Tritanrix HepB
diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Table of contents
Overview
The marketing authorisation for Tritanrix HepB has lapsed because it ceased to be marketed in the European Union more than three years ago and an exemption granted by the European Commission has expired
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Tritanrix HepB : EPAR - Summary for the public (PDF/948.08 KB)
First published: 09/06/2008
Last updated: 07/01/2014 -
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Tritanrix HepB : EPAR - Risk-management-plan summary
First published: 05/03/2014
Authorisation details
| Product details | |
|---|---|
| Name |
Tritanrix HepB
|
| Agency product number |
EMEA/H/C/000093
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J07CA05
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
|
| Revision |
15
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/07/1996
|
| Contact address |
Rue de l'Institut, 89
B-1330 Rixensart Belgium |
Product information
01/01/2014 Tritanrix HepB - EMEA/H/C/000093 - II/0049
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
Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from six weeks onwards (see section 4.2).