Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Bexsero   
Auth. number : EU/1/12/812
Active substance : Meningococcal group B Vaccine (rDNA, component, adsorbed)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07A - Bacterial vaccines
Chemical subgroup: J07AH - Meningococcal vaccines
Chemical substance: J07AH09 - Meningococcus B, multicomponent vaccine
(See WHO ATC Index)
Indication: Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.
The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group B strains in different geographical areas should be considered when vaccinating. See section 5.1 for information on protection against specific group B strains.
The use of this vaccine should be in accordance with official recommendations.
Marketing Authorisation Holder: GlaxoSmithKline Vaccines S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia
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
18/01/2013 Centralised - Authorisation EMEA/H/C/2333 (2013)218 of 14/01/2013
26/03/2013 Rectificative Decision EMEA/H/C/2333 (2013)1849 of 22/03/2013
02/05/2013 Corrigendum (2013)2651 of 29/04/2013
24/10/2013 Centralised - Variation EMEA/H/C/2333/II/5
Updated with Decision(2014)7191 of 01/10/2014
25/04/2014 Centralised - Variation EMEA/H/C/2333/II/8
Updated with Decision(2014)7191 of 01/10/2014
26/06/2014 Centralised - Variation EMEA/H/C/2333/II/12
Updated with Decision(2014)7191 of 01/10/2014
26/06/2014 Centralised - Variation EMEA/H/C/2333/II/13
Updated with Decision(2014)7191 of 01/10/2014
03/10/2014 Centralised - Yearly update (2014)7191 of 01/10/2014
22/01/2015 Centralised - Variation EMEA/H/C/2333/II/24
Updated with Decision(2016)633 of 28/01/2016
23/07/2015 Centralised - Variation EMEA/H/C/2333/II/31
Updated with Decision(2016)633 of 28/01/2016
24/09/2015 Centralised - Variation EMEA/H/C/2333/IAin/37/G
Updated with Decision(2016)633 of 28/01/2016
19/11/2015 Centralised - Variation EMEA/H/C/2333/II/32/G
Updated with Decision(2016)633 of 28/01/2016
01/02/2016 Centralised - Yearly update (2016)633 of 28/01/2016
15/09/2016 Centralised - Variation EMEA/H/C/2333/II/44/G
15/09/2016 Centralised - Variation EMEA/H/C/2333/II/45
08/02/2017 Centralised - Variation EMEA/H/C/2333/IB/49
17/02/2017 Corrigendum (2016)633 of 28/01/2017
06/07/2017 Centralised - Variation EMEA/H/C/2333/II/54