pneumococcal polysaccharide conjugate vaccine (adsorbed)

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Synflorix. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Synflorix.

For practical information about using Synflorix, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 24/05/2023

Authorisation details

Product details
Agency product number
Active substance
  • Pneumococcal polysaccharide serotype 23F
  • Pneumococcal polysaccharide serotype 4
  • Pneumococcal polysaccharide serotype 5
  • Pneumococcal polysaccharide serotype 6B
  • Pneumococcal polysaccharide serotype 7F
  • Pneumococcal polysaccharide serotype 9V
  • Pneumococcal polysaccharide serotype 1
  • Pneumococcal polysaccharide serotype 14
  • Pneumococcal polysaccharide serotype 18C
  • Pneumococcal polysaccharide serotype 19F
International non-proprietary name (INN) or common name
pneumococcal polysaccharide conjugate vaccine (adsorbed)
Therapeutic area (MeSH)
  • Pneumococcal Infections
  • Immunization
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Rue de l'Institut, 89
B-1330 Rixensart

Product information

26/04/2023 Synflorix - EMEA/H/C/000973 - WS2365

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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


Therapeutic indication

Active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. See sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes.

The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.

Assessment history

Changes since initial authorisation of medicine

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