Tritanrix HepB


diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)

This medicine is now withdrawn from use in the European Union.


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

This EPAR was last updated on 07/01/2014

Authorisation details

Product details
Tritanrix HepB
Agency product number
Active substance
  • Diphtheria toxoid
  • hepatitis B surface antigen
  • Bordetella pertussis (inactivated)
  • tetanus toxoid
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)
  • Hepatitis B
  • Tetanus
  • Immunization
  • Whooping Cough
  • Diphtheria
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Rue de l'Institut, 89
B-1330 Rixensart

Product information

01/01/2014 Tritanrix HepB - EMEA/H/C/000093 - II/0049

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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


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).

Assessment history

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