Prevenar 13
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Prevenar 13. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prevenar 13.
Authorisation details
Product details | |
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Name |
Prevenar 13
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Agency product number |
EMEA/H/C/001104
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Active substance |
|
International non-proprietary name (INN) or common name |
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J07AL02
|
Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
43
|
Date of issue of marketing authorisation valid throughout the European Union |
09/12/2009
|
Contact address |
Boulevard de la Plaine 17 |
Product information
01/10/2021 Prevenar 13 - EMEA/H/C/001104 - N/0201
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Vaccines
Therapeutic indication
Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.
Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.
See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.
The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 201523/01/2015
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31/05/2013
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16/11/2012
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23/09/2011