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

On 23 October 2000, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Infanrix Penta (diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) vaccine (adsorbed)), indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis. 

On 30 May 2013, the Marketing Authorisation Holder of Infanrix Penta, GlaxoSmithKline Biologicals, informed the European Medicines Agency that marketing of Infanrix Penta had been permanently ceased on 21 December 2008. In accordance with article 14(5) of Regulation (EC) No 726/2004 ('sunset clause'), the marketing authorisation of a medicinal product lapses if the product has not been marketed in any of the Member States for three consecutive years. 

Because of this, the marketing authorisation for Infanrix Penta is no longer valid. The Marketing Authorisation Holder of Infanrix Penta has confirmed that cessation of marketing was due to lack of demand for this vaccine. 

Pursuant to the expiry of the marketing authorisation, the European Assessment Report (EPAR) for Infanrix Penta is updated to reflect that the marketing authorisation is no longer valid.

Infanrix Penta : EPAR - Summary for the public

Product information

Infanrix Penta : EPAR - Product Information

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

Adopted Reference Number: EMA/378903/2013

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

Adopted Reference 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