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EMA Product

Vaxneuvance

Product approved by European Medicines Agency (EU)

Basic Information

Vaxneuvance

Regulatory Information

EMEA/H/C/005477

Authorised

December 13, 2021

October 14, 2021

7

January 16, 2025

Company Information

the netherlands

Waarderweg 39 2031 BN Haarlem

Merck Sharp & Dohme BV

Drug Classification

Additional Monitoring

Active Substances Detail

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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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