Synflorix

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pneumococcal polysaccharide conjugate vaccine (adsorbed)

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

Overview

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 30/11/2018

Authorisation details

Product details
Name
Synflorix
Agency product number
EMEA/H/C/000973
Active substance
  • pneumococcal polysaccharide serotype 1 / pneumococcal polysaccharide serotype 1, 4, 5, 6b, 7f, 9v, 14, 18c, 19f, 23f / pneumococcal polysaccharide serotype 14 / pneumococcal polysaccharide serotype 18c / pneumococcal polysaccharide serotype 19f
  • pneumococcal polysaccharide serotype 23f / pneumococcal polysaccharide serotype 4 / pneumococcal polysaccharide serotype 5 / pneumococcal polysaccharide serotype 6b / pneumococcal polysaccharide serotype 7f / pneumococcal polysaccharide serotype 9v
International non-proprietary name (INN) or common name
pneumococcal polysaccharide conjugate vaccine (adsorbed)
Therapeutic area (MeSH)
  • Pneumococcal Infections
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07AL52
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
31
Date of issue of marketing authorisation valid throughout the European Union
29/03/2009
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

22/11/2018 Synflorix - EMEA/H/C/000973 - R/0128

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Vaccines

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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