APEXXNAR Suspension for injection Ref.[49639] Active ingredients: Pneumococcus, purified polysaccharides antigen

Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Product name and form

Apexxnar suspension for injection in pre-filled syringe.

Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed).

Pharmaceutical Form
Suspension for injection. The vaccine is a homogeneous white suspension.

Qualitative and quantitative composition

One dose (0.5 mL) contains:

Pneumococcal polysaccharide serotype 1^1,2 2.2 µg
Pneumococcal polysaccharide serotype 3^1,2 2.2 µg
Pneumococcal polysaccharide serotype 4^1,2 2.2 µg
Pneumococcal polysaccharide serotype 5^1,2 2.2 µg
Pneumococcal polysaccharide serotype 6A^1,2 2.2 µg
Pneumococcal polysaccharide serotype 6B^1,2 4.4 µg
Pneumococcal polysaccharide serotype 7F^1,2 2.2 µg
Pneumococcal polysaccharide serotype 8^1,2 2.2 µg
Pneumococcal polysaccharide serotype 9V^1,2 2.2 µg
Pneumococcal polysaccharide serotype 10A^1,2 2.2 µg
Pneumococcal polysaccharide serotype 11A^1,2 2.2 µg
Pneumococcal polysaccharide serotype 12F^1,2 2.2 µg
Pneumococcal polysaccharide serotype 14^1,2 2.2 µg
Pneumococcal polysaccharide serotype 15B^1,2 2.2 µg
Pneumococcal polysaccharide serotype 18C^1,2 2.2 µg
Pneumococcal polysaccharide serotype 19A^1,2 2.2 µg
Pneumococcal polysaccharide serotype 19F^1,2 2.2 µg
Pneumococcal polysaccharide serotype 22F^1,2 2.2 µg
Pneumococcal polysaccharide serotype 23F^1,2 2.2 µg
Pneumococcal polysaccharide serotype 33F^1,2 2.2 µg

¹ Conjugated to CRM197 carrier protein (approximately 51 µg per dose)
² Adsorbed on aluminium phosphate (0.125 mg aluminium per dose)

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Pneumococcus, purified polysaccharides antigen

List of Excipients
Sodium chloride Succinic acid Polysorbate 80 Water for injections For adjuvant, see section 2.

Pack sizes and marketing

0.5 mL suspension for injection in pre-filled syringe (Type I glass) with a tip cap (synthetic isoprene/bromobutyl blend rubber) and a plunger stopper (chlorobutyl rubber).

Pack sizes of 1, 10, and multipack of 50 (5 × 10) prefilled syringes, with or without needle.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/21/1612/001
EU/1/21/1612/002
EU/1/21/1612/003
EU/1/21/1612/004
EU/1/21/1612/005
EU/1/21/1612/006

Drugs

Drug	Countries
APEXXNAR	Austria, Estonia, Finland, Croatia, Poland, Romania

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