Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Hexyon   
Auth. number : EU/1/13/829
Active substance : diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07C - Bacterial and viral vaccines, combined
Chemical subgroup: J07CA - Bacterial and viral vaccines, combined
Chemical substance: J07CA09 - Diphtheria-hemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B
(See WHO ATC Index)
Indication: Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib)
Marketing Authorisation Holder: Sanofi Pasteur Europe
2 avenue Pont Pasteur, 69007 Lyon, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/04/2013 Centralised - Authorisation EMEA/H/C/2796 (2013)2303 of 17/04/2013
11/11/2013 Centralised - Variation EMEA/H/C/2796/IA/4
Updated with Decision(2014)8188 of 27/10/2014
08/05/2014 Centralised - Variation EMEA/H/C/2796/IA/10
Updated with Decision(2014)8188 of 27/10/2014
29/10/2014 Centralised - Yearly update (2014)8188 of 27/10/2014
07/01/2015 Centralised - Variation EMEA/H/C/2796/IB/20
Updated with Decision(2015)1391 of 24/02/2015
26/02/2015 Centralised - 2-Monthly update EMEA/H/C/2796/WS/676 (2015)1391 of 24/02/2015
21/05/2015 Centralised - Variation EMEA/H/C/2796/WS/702
Updated with Decision(2016)3164 of 20/05/2016
26/05/2015 Centralised - Notification EMEA/H/C/2796/N/30
Updated with Decision(2016)3164 of 20/05/2016
19/11/2015 Centralised - Variation EMEA/H/C/2796/WS/789
Updated with Decision(2016)3164 of 20/05/2016
28/04/2016 Centralised - Variation EMEA/H/C/2796/WS/907
Updated with Decision(2016)7416 of 11/11/2016
24/05/2016 Centralised - Yearly update (2016)3164 of 20/05/2016
15/11/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2796/T/57 (2016)7416 of 11/11/2016
03/01/2017 Centralised - Notification EMEA/H/C/2796/N/60
21/04/2017 Centralised - Variation EMEA/H/C/2796/WS/1146
21/04/2017 Centralised - Variation EMEA/H/C/2796/WS/1148/G