Prevenar

pneumococcal saccharide conjugated vaccine, adsorbed

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The marketing authorisation for Prevenar has been withdrawn at the request of the marketing authorisation holder. 

Name Language First published Last updated
Prevenar : EPAR - Summary for the public BG = bălgarski 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public ES = español 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public CS = čeština 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public DA = dansk 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public DE = Deutsch 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public ET = eesti keel 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public EL = elliniká 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public EN = English 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public FR = français 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public IT = italiano 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public LV = latviešu valoda 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public LT = lietuvių kalba 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public HU = magyar 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public MT = Malti 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public NL = Nederlands 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public PL = polski 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public PT = português 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public RO = română 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public SK = slovenčina 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public SL = slovenščina 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public FI = suomi 2008-03-17 2017-11-24
Prevenar : EPAR - Summary for the public SV = svenska 2008-03-17 2017-11-24

This EPAR was last updated on 24/11/2017 .

Authorisation details

Product details

Product details for Prevenar
NamePrevenar
Agency product numberEMEA/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 Pneumococcal InfectionsImmunization
Anatomical therapeutic chemical (ATC) code J07AL02

Publication details

Publication details for Prevenar
Marketing-authorisation holder

Pfizer Limited

Revision23
Date of issue of marketing authorisation valid throughout the European Union02/02/2001

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

Product information

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

Name Language First published Last updated
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24
Prevenar : EPAR - Product Information SV = svenska 2009-10-08 2017-11-24

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.


Name Language First published Last updated
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24
Prevenar : EPAR - All Authorised presentations SV = svenska 2008-04-25 2017-11-24

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

Initial marketing-authorisation documents

Name Language First published Last updated
Prevenar : EPAR - Procedural steps taken before authorisation SV = svenska 2005-10-21 2017-11-24
Prevenar : EPAR - Scientific Discussion SV = svenska 2005-10-21 2017-11-24

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Prevenar