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
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 | |
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Name of medicinal product |
Globorix
|
Agency opinion number |
H/W/848
|
Opinion status |
Withdrawn application
|
Active substance |
|
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) |
|
Anatomical therapeutic chemical (ATC) code |
J07CA09
|
Publication details | |
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Opinion holder |
GlaxoSmithKline Biologicals s.a. |
Pharmacotherapeutic group
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
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List item
Withdrawal assessment report for Globorix (PDF/1.08 MB)
Adopted
First published: 18/12/2007
EMEA/CHMP/300656/2007 -
List item
GlaxoSmithKline Biologicals withdraws its application for a scientific opinion for Globorix (PDF/33.57 KB)
First published: 16/10/2007
Last updated: 16/10/2007
EMEA/475583/2007