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.
Authorisation details
Product details | |
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Name |
Bexsero
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Agency product number |
EMEA/H/C/002333
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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
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International non-proprietary name (INN) or common name |
meningococcal group-B vaccine (rDNA, component, adsorbed)
|
Therapeutic area (MeSH) |
Meningitis, Meningococcal
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Anatomical therapeutic chemical (ATC) code |
J07AH09
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Publication details | |
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Marketing-authorisation holder |
GSK Vaccines S.r.l.
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Revision |
19
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Date of issue of marketing authorisation valid throughout the European Union |
13/01/2013
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Contact address |
Product information
22/11/2018 Bexsero - EMEA/H/C/002333 - PSUSA/00010043/201801
Contents
- 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
Therapeutic indication
Active immunisation against invasive disease caused by Neisseria meningitidis serogroup-B strains.