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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.
Product information documents contain:
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.