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Withdrawn

This medicine's authorisation has been withdrawn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

Overview

The marketing authorisation for Hexavac has been withdrawn at the request of the marketing-authorisation holder.

Hexavac : EPAR - Summary for the public

Product information

Hexavac : EPAR - 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).

Hexavac : EPAR - All Authorised presentations

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 2 poliovirus (MEF 1)
  • 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

Vaccines

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000298
• Marketing authorisation holder:
  Sanofi Pasteur MSD, SNC

  Sanofi Pasteur MSD SNC; 8 rue Jonas Salk; F-69007 Lyon; FRANCE

• Marketing authorisation issued:
  23/10/2000

Assessment history

Changes since initial authorisation of medicine

Hexavac : EPAR - Procedural steps taken and scientific information after authorisation

Hexavac : EPAR - Scientific Conclusion

Hexavac : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Hexavac : EPAR - Procedural steps taken before authorisation

Hexavac : EPAR - Scientific Discussion