Prevenar
Withdrawn
This medicine's authorisation has been withdrawn
pneumococcal saccharide conjugated vaccine, adsorbed
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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Assessment Report (EPAR) for Prevenar is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
PSUSA/00002452/201408
22/06/2015
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).
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
VaccinesTherapeutic 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.
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