Quintanrix
Withdrawn
This medicine's authorisation has been withdrawn
diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 1 August 2008, the marketing authorisation holder (MAH) responsible for Quintanrix, GlaxoSmithKline Biologicals, notified the European Commission of its decision to voluntarily withdraw the marketing authorisation for Quintanrix for commercial reasons. The MAH confirmed that this decision is not related to any safety concerns with Quintanrix.
Quintanrix was never marketed in the European Union. Quintanrix (diphtheria, tetanus, pertussis [whole cell], hepatitis B [rDNA] and Haemophilus type b conjugate vaccine [adsorbed]) was indicated for primary immunisation of infants during the first year of life against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and invasive diseases caused by Haemophilus influenzae type b (‘Hib’, a bacterium that causes meningitis), and for booster immunisation of young children during the second year of life. Alternative vaccines are available throughout the European Union. These contain the same active substances as Quintanrix (diphtheria toxoid, tetanus toxoid, inactivated Bordetella pertussis [a bacterium that causes whooping cough], recombinant hepatitis B surface antigen [r-HBsAg, parts of the hepatitis B virus] and Hib polysaccharides [sugars from the bacterium Hib]).
On 28 August 2008, the European Commission issued a decision to withdraw the marketing authorisation for Quintanrix. Pursuant to this decision, the European public assessment report (EPAR) for Quintanrix is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0008
11/12/2007
This medicine’s product information is available in all official EU languages.
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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).
Product details
- Name of medicine
- Quintanrix
- Active substance
- Diphtheria toxoid
- tetanus toxoid
- inactivated Bordetella pertussis
- hepatitis B surface antigen (rDNA)
- Haemophilus influenzae type b polysaccharide
- International non-proprietary name (INN) or common name
- diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)
- Therapeutic area (MeSH)
- Hepatitis B
- Tetanus
- Immunization
- Meningitis, Haemophilus
- Whooping Cough
- Diphtheria
- Anatomical therapeutic chemical (ATC) code
- J07CA10
Pharmacotherapeutic group
VaccinesTherapeutic indication
Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.
The use of Quintanrix should be determined on the basis of official recommendations.
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