Apexxnar
pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
Table of contents
Overview
Apexxnar is a vaccine to protect adults against pneumonia (infection of the lungs) and invasive diseases (diseases that occur when a bacterium spreads through the body) caused by the bacterium Streptococcus pneumoniae (S. pneumoniae).
Apexxnar contains parts from 20 different types of S. pneumoniae.
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Apexxnar : EPAR - Medicine Overview (PDF/120.36 KB)
First published: 02/03/2022
EMA/779603/2021 -
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Apexxnar : EPAR - Risk management plan summary (PDF/122.67 KB)
First published: 02/03/2022
Last updated: 16/01/2023
Authorisation details
Product details | |
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Name |
Apexxnar
|
Agency product number |
EMEA/H/C/005451
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Active substance |
|
International non-proprietary name (INN) or common name |
pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
|
Therapeutic area (MeSH) |
Pneumococcal Infections
|
Anatomical therapeutic chemical (ATC) code |
J07AL02
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
14/02/2022
|
Contact address |
Boulevard de la Plaine 17 |
Product information
01/12/2022 Apexxnar - EMEA/H/C/005451 - II/0006
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 and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. Apexxnar should be used in accordance with official recommendations. |