Prevenar

RSS

pneumococcal saccharide conjugated vaccine, adsorbed

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Prevenar has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 24/11/2017

Authorisation details

Product details
Name
Prevenar
Agency product number
EMEA/H/C/000323
Active substance
  • pneumococcal polysaccharide serotype 4 / pneumococcal polysaccharide serotype 6B / pneumococcal polysaccharide serotype 9V / pneumococcal polysaccharide serotype 14
  • pneumococcal oligosaccharide serotype 18C / pneumococcal polysaccharide serotype 19F / pneumococcal polysaccharide serotype 23F
International non-proprietary name (INN) or common name
pneumococcal saccharide conjugated vaccine, adsorbed
Therapeutic area (MeSH)
  • Pneumococcal Infections
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07AL02
Publication details
Marketing-authorisation holder
Pfizer Limited
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
02/02/2001
Contact address
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

22/06/2015 Prevenar - EMEA/H/C/000323 - PSUSA/00002452/201408

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 disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.

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

Assessment history

Changes since initial authorisation of medicine

  • List item

    Prevenar-H-C-PSUSA-00002452-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/527.72 KB)


    First published: 16/07/2015
    Last updated: 24/11/2017
    EMA/CHMP/722875/2014

  • List item

    Prevenar-H-C-323-P46-0130 : EPAR - Assessment Report (PDF/1.06 MB)

    Adopted

    First published: 23/02/2015
    Last updated: 24/11/2017
    EMA/124579/2015

  • List item

    Prevenar-H-C-323-P46-0132 : EPAR - Assessment Report (PDF/2.48 MB)

    Adopted

    First published: 23/02/2015
    Last updated: 24/11/2017
    EMA/125121/2015

  • List item

    Prevenar-H-C-323-P46-0129 : EPAR - Assessment Report (PDF/1.05 MB)

    Adopted

    First published: 19/02/2015
    Last updated: 24/11/2017
    EMA/123675/2015

  • List item

    Prevenar-H-C-323-II-76 : EPAR - Scientific Discussion - Variation (PDF/635.94 KB)

    Adopted

    First published: 29/08/2007
    Last updated: 24/11/2017

  • List item

    Prevenar-H-C-323-II-80 : EPAR - Scientific Discussion - Variation (PDF/673.49 KB)

    Adopted

    First published: 29/08/2007
    Last updated: 24/11/2017

  • List item

    Prevenar : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/563.25 KB)


    First published: 21/10/2005
    Last updated: 24/11/2017

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