Prevenar

Withdrawn

This medicine's authorisation has been withdrawn

pneumococcal saccharide conjugated vaccine, adsorbed

Overview

On 21 November 2017, the European Commission withdrew the marketing authorisation for Prevenar (pneumococcal polysaccharide conjugate vaccine (7-valent, adsorbed)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Pfizer Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Prevenar was granted marketing authorisation in the EU on 2 February 2001 for immunisation against disease caused by Streptococcus pneumoniae. The marketing authorisation was initially valid for a 5- year period. It was subsequently renewed for an additional 5-year period in 2006 and then granted unlimited validity in 2011. 

The European Public Assessment Report (EPAR) for Prevenar is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Prevenar : EPAR - Summary for the public

Product information

Prevenar : EPAR - Product Information

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
• Withdrawal of marketing authorisation:
  21/11/2017
• 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

Adopted Reference Number: EMA/124579/2015

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

Adopted Reference Number: EMA/125121/2015

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

Adopted Reference 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