Bexsero
meningococcal group B Vaccine (rDNA, component, adsorbed)
Table of contents
Overview
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.
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List item
Bexsero : EPAR - Summary for the public (PDF/79.03 KB)
First published: 28/01/2013
Last updated: 11/07/2018
EMEA/H/C/002333 -
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List item
Bexsero : EPAR - Risk management plan summary (PDF/107.74 KB)
First published: 10/11/2021
Authorisation details
Product details | |
---|---|
Name |
Bexsero
|
Agency product number |
EMEA/H/C/002333
|
Active substance |
|
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 |
J07AH09
|
Publication details | |
---|---|
Marketing-authorisation holder |
GSK Vaccines S.r.l.
|
Revision |
32
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Date of issue of marketing authorisation valid throughout the European Union |
13/01/2013
|
Contact address |
Via Fiorentina, 1
IT-53100 Siena Italy |
Product information
26/04/2023 Bexsero - EMEA/H/C/002333 - WS2365
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic indication
Active immunisation against invasive disease caused by Neisseria meningitidis serogroup-B strains.