Medicine information APEXXNAR suspension for injection in pre-filled syringe

Product code:
W68478002
Quantity:
1
Indicated for:
prevention of pneumococcal disease
Route of administration:
injectable
ATC
J07AL02 — Antiinfectives for systemic use | Bacterial vaccines | Pneumococcal vaccines
The 20-valent adsorbed pneumococcal polysaccharide conjugate vaccine is designed to protect against infections caused by 20 different serotypes of the Streptococcus pneumoniae bacterium. It is used to prevent invasive pneumococcal diseases such as pneumonia, meningitis, and sepsis, as well as otitis media, particularly in high-risk groups such as young children, the elderly, and individuals with chronic conditions or immunosuppression.

This vaccine is a conjugate and adsorbed product, meaning that the capsular polysaccharides of the bacterium are linked to a carrier protein and fixed onto an adjuvant (usually aluminum hydroxide). This combination enhances the immune response, increasing the vaccine's effectiveness, especially in children under 2 years old and individuals with weakened immune systems.

The vaccine is administered via intramuscular injection according to a vaccination schedule established by public health authorities. It is well-tolerated, but mild side effects such as pain at the injection site, fever, fatigue, or irritability may occur. Severe reactions, such as allergic responses, are rare.

Following the recommended vaccination schedule is essential to ensure optimal protection against pneumococcal diseases.

General data about APEXXNAR

Substance:
20-valent adsorbed conjugated polysaccharide pneumococcal vaccine
Date of latest medicines list:
01-06-2026
Product code:
W68478002
Pharmaceutical form:
suspension for injection in pre-filled syringe
Quantity:
1
Product type:
Original
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
PFIZER MANUFACTURING BELGIUM N.V. - BELGIA
Holder:
PFIZER EUROPE MA EEIG - BELGIA
Number:
1612/2022/02
Shelf life:
24 months

Official documents

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Source institution
EMA
Document language
English
Source record: first published
02/03/2022
Source record: last updated
18/11/2025

Warnings:

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring

This medicine is subject to additional monitoring.

Refrigerated storage

Store in the refrigerator as instructed in the leaflet.

Protect from light

Store protected from light.