Prevenar 13

RSS

pneumococcal polysaccharide conjugate vaccine (13-valent, 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 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.

This EPAR was last updated on 24/10/2018

Authorisation details

Product details
Name
Prevenar 13
Agency product number
EMEA/H/C/001104
Active substance
  • pneumococcal polysaccharide serotype 1 / pneumococcal polysaccharide serotype 14 / pneumococcal polysaccharide serotype 18C / pneumococcal polysaccharide serotype 19A
  • pneumococcal polysaccharide serotype 19F / pneumococcal polysaccharide serotype 23F / pneumococcal polysaccharide serotype 3 / pneumococcal polysaccharide serotype 4
  • pneumococcal polysaccharide serotype 5
  • pneumococcal polysaccharide serotype 6A
  • pneumococcal polysaccharide serotype 6B / pneumococcal polysaccharide serotype 7F / pneumococcal polysaccharide serotype 9V protein
International non-proprietary name (INN) or common name
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Therapeutic area (MeSH)
  • Pneumococcal Infections
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07AL02
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
31
Date of issue of marketing authorisation valid throughout the European Union
08/12/2009
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

26/09/2018 Prevenar 13 - EMEA/H/C/001104 - T/0170

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 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

Changes since initial authorisation of medicine

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