Prevenar 13
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Prevenar 13. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prevenar 13.
Authorisation details
Product details | |
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Name |
Prevenar 13
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Agency product number |
EMEA/H/C/001104
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Active substance |
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International non-proprietary name (INN) or common name |
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J07AL02
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Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
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Revision |
40
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Date of issue of marketing authorisation valid throughout the European Union |
09/12/2009
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Contact address |
Product information
27/11/2020 Prevenar 13 - EMEA/H/C/001104 - N/0194
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
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Pharmacotherapeutic group
Vaccines
Therapeutic indication
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 17 years of age.
Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.
See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.
The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 201523/01/2015
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31/05/2013
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16/11/2012
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23/09/2011