Prevenar

Withdrawn

This medicine's authorisation has been withdrawn

pneumococcal saccharide conjugated vaccine, adsorbed

Overview

The marketing authorisation for Prevenar has been withdrawn at the request of the marketing authorisation holder.

Prevenar : EPAR - Summary for the public

Product information

Prevenar : EPAR - Product Information

Latest procedure affecting product information: PSUSA/00002452/201408

22/06/2015

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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Prevenar : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Prevenar
• Active substance:
  • pneumococcal oligosaccharide serotype 18C
  • Pneumococcal polysaccharide serotype 19F
  • Pneumococcal polysaccharide serotype 23F
  • Pneumococcal polysaccharide serotype 4
  • Pneumococcal polysaccharide serotype 6B
  • Pneumococcal polysaccharide serotype 9V
  • Pneumococcal polysaccharide serotype 14
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000323
• Marketing authorisation holder:
  Pfizer Limited

  Ramsgate Road; Sandwich; Kent; CT13 9NJ; United Kingdom

• Marketing authorisation issued:
  02/02/2001
• Revision:
  23

Assessment history

Changes since initial authorisation of medicine

Prevenar-H-C-PSUSA-00002452-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/722875/2014

Prevenar-H-C-323-P46-0130 : EPAR - Assessment Report

AdoptedReference Number: EMA/124579/2015

Prevenar-H-C-323-P46-0132 : EPAR - Assessment Report

AdoptedReference Number: EMA/125121/2015

Prevenar-H-C-323-P46-0129 : EPAR - Assessment Report

AdoptedReference Number: EMA/123675/2015

Prevenar-H-C-323-II-76 : EPAR - Scientific Discussion - Variation

Adopted

Prevenar-H-C-323-II-80 : EPAR - Scientific Discussion - Variation

Adopted

Prevenar : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Prevenar : EPAR - Procedural steps taken before authorisation

Prevenar : EPAR - Scientific Discussion