Apexxnar

RSS

pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 16/01/2023

Authorisation details

Product details
Name
Apexxnar
Agency product number
EMEA/H/C/005451
Active substance
  • Pneumococcal polysaccharide serotype 1
  • Pneumococcal polysaccharide serotype 3
  • Pneumococcal polysaccharide serotype 4
  • Pneumococcal polysaccharide serotype 5
  • Pneumococcal polysaccharide serotype 6A
  • Pneumococcal polysaccharide serotype 6B
  • Pneumococcal polysaccharide serotype 7F
  • Pneumococcal polysaccharide serotype 8
  • Pneumococcal polysaccharide serotype 9V
  • Pneumococcal polysaccharide serotype 10A
  • Pneumococcal polysaccharide serotype 11A
  • Pneumococcal polysaccharide serotype 12F
  • Pneumococcal polysaccharide serotype 14
  • Pneumococcal polysaccharide serotype 15b
  • Pneumococcal polysaccharide serotype 18C
  • Pneumococcal polysaccharide serotype 19A
  • Pneumococcal polysaccharide serotype 19F
  • Pneumococcal polysaccharide serotype 22F
  • Pneumococcal polysaccharide serotype 23F
  • Pneumococcal polysaccharide serotype 33F
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 monitoringAdditional 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
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
14/02/2022
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

01/12/2022 Apexxnar - EMEA/H/C/005451 - II/0006

Other EU languages available icon 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:

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.

See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.

Apexxnar should be used in accordance with official recommendations.

 

 

Assessment history

How useful was this page?

Add your rating
Average
2 ratings
2 ratings