Vaxneuvance

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pneumococcal polysaccharide conjugate vaccine (adsorbed)

Authorised
This medicine is authorised for use in the European Union.

Overview

Vaxneuvance is a vaccine used to protect against pneumonia (infection of the lungs) and other invasive diseases (diseases that occur when a bacterium spreads through the body) caused by the bacterium Streptococcus pneumoniae (S. pneumoniae) in people aged 18 and older.

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.

This EPAR was last updated on 25/04/2022

Authorisation details

Product details
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 monitoringAdditional 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
Marketing-authorisation holder
Merck Sharp & Dohme B.V. 
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
13/12/2021
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

22/04/2022 Vaxneuvance - EMEA/H/C/005477 - IB/0003

Product information documents contain:

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

pneumococcus, purified polysaccharides antigen conjugated

Therapeutic indication

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.

Assessment history

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