Synflorix
pneumococcal polysaccharide conjugate vaccine (adsorbed)
Table of contents
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.
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List item
Synflorix : EPAR - Summary for the public (PDF/91.65 KB)
First published: 12/05/2009
Last updated: 09/01/2018 -
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List item
Synflorix : EPAR - Risk-management-plan summary (PDF/112.52 KB)
First published: 01/04/2020
Authorisation details
Product details | |
---|---|
Name |
Synflorix
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Agency product number |
EMEA/H/C/000973
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Active substance |
|
International non-proprietary name (INN) or common name |
pneumococcal polysaccharide conjugate vaccine (adsorbed)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J07AL52
|
Publication details | |
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Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
|
Revision |
32
|
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
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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.