Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Bexsero   
Auth. number : EU/1/12/812
INN : 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: Novartis Vaccines and Diagnostics 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