Globorix: Opinion on medicine for use outside EU

Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw), hepatitis B (rDNA) (HBV), Haemophilus type b (HIB) and Neisseria meningitidis group A and C (MenAC) conjugate vaccine (adsorbed)

Table of contents

Opinion on medicine for use outside the European Union
Withdrawn application

Overview

On 11 October 2007, GlaxoSmithKline Biologicals s.a. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a scientific opinion for Globorix, for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B, invasive disease caused by Haemophilus influenzae type b and Neisseria meningitidis group A and C, and for booster immunisation of young children during the second year of life.

The application for a CHMP scientific opinion for Globorix was being evaluated in co-operation with the World Health Organization (WHO) because it was to be used as part of the ‘Expanded Programme on Immunization’. Globorix was to be used exclusively in markets outside the European Union, primarily in sub-Saharan Africa.

Opinion details

Product details
Name of medicinal product
Globorix
Agency opinion number
H/W/848
Opinion status
Withdrawn application
Active substance
  • Diphtheria toxoid
  • Tetanus toxoid
  • Bordetella pertussis (inactivated)
  • Haemophilus influenzae type b polysaccharide
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid
  • hepatitis B surface antigen
International non-proprietary name (INN) or common name
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw), hepatitis B (rDNA) (HBV), Haemophilus type b (HIB) and Neisseria meningitidis group A and C (MenAC) conjugate vaccine (adsorbed)
Therapeutic area (MeSH)
  • Immunization
  • Hepatitis B
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Bordetella pertussis
  • Haemophilus influenzae type b
  • Neisseria meningitidis, Serogroup A
  • Neisseria meningitidis, Serogroup C
Anatomical therapeutic chemical (ATC) code
J07CA09
Publication details
Opinion holder

GlaxoSmithKline Biologicals s.a.

Pharmacotherapeutic group

Bacterial and viral vaccines, combined

Therapeutic indication

Primary immunisation of infants (during the first year of life) and for booster immunisation (during the second year of life) against diphtheria, tetanus, pertussis, hepatitis B, invasive disease caused by Haemophilus influenzae type b and Neisseria meningitidis serogroups A and C.

Assessment history

How useful was this page?

Add your rating