Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Hexacima   
Auth. number : EU/1/13/828
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: 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
Marketing Authorisation Holder: Sanofi Pasteur SA
2 avenue Pont Pasteur, F-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/2702 (2013)2302 of 17/04/2013
11/11/2013 Centralised - Variation EMEA/H/C/2702/IA/4
Updated with Decision(2014)8291 of 30/10/2014
03/11/2014 Centralised - Yearly update (2014)8291 of 30/10/2014
26/02/2015 Centralised - 2-Monthly update EMEA/H/C/2702/WS/676 (2015)1392 of 24/02/2015
22/05/2015 Centralised - Variation EMEA/H/C/2702/WS/702
Updated with Decision(2016)316 of 13/05/2016
30/07/2015 Centralised - Notification EMEA/H/C/2702/N/33
Updated with Decision(2016)316 of 13/05/2016
19/11/2015 Centralised - Variation EMEA/H/C/2702/WS/789
Updated with Decision(2016)316 of 13/05/2016
03/02/2016 Centralised - Notification EMEA/H/C/2702/N/44
Updated with Decision(2016)316 of 13/05/2016
24/05/2016 Centralised - Yearly update (2016)316 of 13/05/2016