Bexsero - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

meningococcal group B Vaccine (rDNA, component, adsorbed)

Opinion

On 12 November 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bexsero. The marketing authorisation holder for this medicinal product is Glaxosmithkline Vaccines S.r.l.

The CHMP adopted an extension to the existing indication, as follows:

Bexsero is indicated for active immunisation of individuals from 2 months 6 weeks 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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold, removed text as strikethrough.

CHMP post-authorisation summary of positive opinion for Bexsero (VR-0000334463)

Adopted Reference Number: EMADOC-1700519818-3500154

Key facts

• Name of medicine:
  Bexsero
• EMA product number:
  EMEA/H/C/002333
• Active substance:
  • outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254)
  • recombinant Neisseria meningitidis group B fHbp fusion protein
  • recombinant Neisseria meningitidis group B NadA protein
  • recombinant Neisseria meningitidis group B NHBA fusion protein
• International non-proprietary name (INN) or common name:
  meningococcal group B Vaccine (rDNA, component, adsorbed)
• Therapeutic area (MeSH):
  Meningitis, Meningococcal
• Anatomical therapeutical chemical (ATC) code:
  J07AH09
• Marketing authorisation holder:
  GSK Vaccines S.r.l.
• Date of opinion:
  12/11/2026
• Status:
  Positive