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Community Register of medicinal products

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: J - General antiinfectives for systemic use
J07 - Vaccines
J07A - Bacterial vaccines
J07AH - Meningococcal vaccines
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

The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be 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