meningococcal group-B vaccine (rDNA, component, adsorbed)

This medicine is authorised for use in the European Union.


Bexsero is a vaccine used to protect individuals from the age of two months against invasive meningococcal disease caused by one group of the bacterium Neisseria meningitidis (group B). Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).

Bexsero contains parts of the bacteria N. meningitidis group B.

This EPAR was last updated on 11/07/2018

Authorisation details

Product details
Agency product number
Active substance
recombinant Neisseria meningitidis group-B NHBA fusion protein / recombinant Neisseria meningitidis group-B NadA protein / recombinant Neisseria meningitidis group B fHbp fusion protein / outer membrane vesicles from Neisseria meningitidis group-B strain NZ98/254 measured as amount of total protein containing the PortA P1.4
International non-proprietary name (INN) or common name
meningococcal group-B vaccine (rDNA, component, adsorbed)
Therapeutic area (MeSH)
Meningitis, Meningococcal
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
GSK Vaccines S.r.l.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Via Fiorentina, 1
IT-53100 Siena

Product information

06/06/2018 Bexsero - EMEA/H/C/002333 - II/0059


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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Pharmacotherapeutic group

Meningococcal vaccines

Therapeutic indication

Active immunisation against invasive disease caused by Neisseria meningitidis serogroup-B strains.

Assessment history

Changes since initial authorisation of medicine

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