Hexavac

diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

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The marketing authorisation for Hexavac has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Hexavac : EPAR - Summary for the public ES = español 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public CS = čeština 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public DA = dansk 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public DE = Deutsch 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public ET = eesti keel 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public EL = elliniká 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public EN = English 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public FR = français 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public IT = italiano 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public LV = latviešu valoda 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public LT = lietuvių kalba 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public HU = magyar 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public NL = Nederlands 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public PL = polski 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public PT = português 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public SK = slovenčina 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public SL = slovenščina 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public FI = suomi 2005-10-25 2012-08-16
Hexavac : EPAR - Summary for the public SV = svenska 2005-10-25 2012-08-16

This EPAR was last updated on 16/08/2012 .

Authorisation details

Product details

Product details for Hexavac
NameHexavac
Agency product numberEMEA/H/C/000298
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 Meningitis, HaemophilusHepatitis BDiphtheriaPoliomyelitisWhooping CoughImmunizationTetanus
Anatomical therapeutic chemical (ATC) code J07CA

Publication details

Publication details for Hexavac
Marketing-authorisation holder

Sanofi Pasteur MSD, SNC

Revision0
Date of issue of marketing authorisation valid throughout the European Union23/10/2000

Contact address:

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

Product information

Product information

28/06/2012  Hexavac -EMEA/H/C/000298

Name Language First published Last updated
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16
Hexavac : EPAR - Product Information SV = svenska 2006-03-23 2012-08-16

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - All Authorised presentations SV = svenska 2005-10-25 2012-08-16

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Hexavac : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2006-03-23 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac-H-C-298-Z-28 : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Scientific Conclusion SV = svenska 2006-03-21 2012-08-16
Hexavac : EPAR - Steps taken after authorisation when a cutoff date has been used SV = svenska 2005-10-25 2012-08-16

Initial marketing-authorisation documents

Name Language First published Last updated
Hexavac : EPAR - Procedural steps taken before authorisation SV = svenska 2005-10-25 2012-08-16
Hexavac : EPAR - Scientific Discussion SV = svenska 2005-10-25 2012-08-16

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Hexavac