Infanrix Penta


diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)

This medicine is now withdrawn from use in the European Union.


This marketing authorisation for Infanrix Penta has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

This EPAR was last updated on 23/08/2013

Authorisation details

Product details
Infanrix Penta
Agency product number
Active substance
  • Diphtheria toxoid
  • tetanus toxoid
  • Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin)
  • poliovirus (inactivated) (type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain))
  • hepatitis B surface antigen
International non-proprietary name (INN) or common name
diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Therapeutic area (MeSH)
  • Hepatitis B
  • Tetanus
  • Immunization
  • Whooping Cough
  • Poliomyelitis
  • 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

31/08/2010 Infanrix Penta - EMEA/H/C/000295 - R/0067

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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

Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.

Assessment history

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