Vaxneuvance
pneumococcal polysaccharide conjugate vaccine (adsorbed)
Table of contents
Overview
Vaxneuvance is a vaccine used to protect against three types of infections caused by the bacterium Streptococcus pneumoniae (S. pneumoniae):
- acute otitis media (ear infection), in children aged from 6 weeks to less than 18 years
- pneumonia (infection of the lungs), in adults and children from 6 weeks of age;
- invasive disease in adults and children from 6 weeks of age. (Invasive disease occurs when the bacterium spreads through the body, causing conditions such as septicaemia (blood infection) and meningitis (infection of the membranes around the brain and spine)).
Vaxneuvance contains parts from 15 different types of the S. pneumoniae bacterium. It also contains an adjuvant, a substance containing aluminium, to stimulate a better immune response.
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List item
Vaxneuvance : EPAR - Medicine overview (PDF/149.8 KB)
First published: 17/01/2022
Last updated: 29/11/2022
EMA/804710/2022 -
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Vaxneuvance : EPAR - Risk management plan summary (PDF/91.15 KB)
First published: 17/01/2022
Last updated: 12/05/2023
Authorisation details
Product details | |
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Name |
Vaxneuvance
|
Agency product number |
EMEA/H/C/005477
|
Active substance |
pneumococcal polysaccharide conjugate vaccine (adsorbed)
|
International non-proprietary name (INN) or common name |
pneumococcal polysaccharide conjugate vaccine (adsorbed)
|
Therapeutic area (MeSH) |
Pneumococcal Infections
|
Anatomical therapeutic chemical (ATC) code |
J07AL02
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
13/12/2021
|
Contact address |
Waarderweg 39 |
Product information
26/04/2023 Vaxneuvance - EMEA/H/C/005477 - II/0013
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
Vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.
Vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.
The use of Vaxneuvance should be in accordance with official recommendations.