Hexavac
Withdrawn
This medicine's authorisation has been withdrawn
diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 23 October 2000, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Hexavac (diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis b (recombinant) and haemophilus influenzae type b conjugate vaccine, adjuvanted), which had been approved for diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b immunisation.
On 17 November 2005, the European Commission suspended the marketing authorisation on the recommendation of the Agency’s Committee for Medicinal Products for Human Use (CHMP) further to the CHMP’s review of the short and long-term protection afforded by recombinant hepatitis B vaccines. The marketing authorisation holder (MAH) for Hexavac was Sanofi Pasteur MSD, SNC.
The European Commission was notified by a letter dated 11 April 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Hexavac for commercial reasons. Hexavac has not been marketed in any EU country since the suspension in 2005. On 28 June 2012, the European Commission issued a decision withdrawing the marketing authorisation for Hexavac.
Pursuant to this decision the European Public Assessment Report for Hexavac is updated to reflect the fact that the marketing authorisation is no longer valid.
Product information
28/06/2012
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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
- Hexavac
- Active substance
- purified diphtheria toxoid
- purified tetanus toxoid
- purified pertussis toxoid
- purified pertussis filamentous haemagglutinin
- hepatitis B surface antigen
- Inactivated Type 1 Poliovirus (Mahoney)
- Inactivated Type 3 Poliovirus (Saukett)
- Haemophilus influenzae type b polysaccharide
- International non-proprietary name (INN) or common name
- diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted
- Therapeutic area (MeSH)
- Hepatitis B
- Tetanus
- Immunization
- Meningitis, Haemophilus
- Whooping Cough
- Poliomyelitis
- Diphtheria
- Anatomical therapeutic chemical (ATC) code
- J07CA
Pharmacotherapeutic group
VaccinesTherapeutic indication
This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
Assessment history
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