Overview

The marketing authorisation for Prevenar has been withdrawn at the request of the marketing authorisation holder.

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Product information

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Latest procedure affecting product information: PSUSA/00002452/201408

22/06/2015

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

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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

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