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Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (adsorbed))

Region
🇪🇺 EU
Active substance
pneumococcal polysaccharide conjugate vaccine (adsorbed)
Company
Merck Sharp & Dohme B.V.
Status
Authorised
Therapeutic area
Pneumococcal Infections
CHMP opinion
Thu 14 Oct 2021
EU approval
Mon 13 Dec 2021
Application
EMEA/H/C/005477
ATC
J07AL02
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.