Infanrix Penta

Lapsed

This medicine's authorisation has lapsed

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

Overview

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.

Infanrix Penta : EPAR - Summary for the public

Product information

Infanrix Penta : EPAR - Product Information

Latest procedure affecting product information: R/0067

31/08/2010

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).

Infanrix Penta : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Infanrix Penta
• 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:
  J07CA12

Pharmacotherapeutic group

Vaccines

Therapeutic indication

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

Authorisation details

• EMA product number:
  EMEA/H/C/000295
• Marketing authorisation holder:
  GlaxoSmithKline Biologicals S.A.

  Rue de l'Institut, 89; B-1330 Rixensart; Belgium

• Marketing authorisation issued:
  23/10/2000
• Lapse of marketing authorisation:
  30/05/2013
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Infanrix Penta : EPAR - Procedural steps taken and scientific information after authorisation

Infanrix Penta-H-C-295-P45-47 : EPAR - Assessment Report

AdoptedReference Number: EMA/378903/2013

Infanrix Penta-H-C-295-P46-59 : EPAR - Assessment Report

AdoptedReference Number: EMA/379037/2013

Infanrix Penta : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Infanrix Penta : EPAR - Scientific Discussion

Infanrix Penta : EPAR - Procedural steps taken before authorisation