VAXNEUVANCE Suspension for injection Ref.[28342] Active ingredients: Pneumococcus, purified polysaccharides antigen

Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Vaxneuvance suspension for injection in pre-filled syringe.

Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed).

Pharmaceutical Form
Suspension for injection (injection). The vaccine is an opalescent suspension.

Qualitative and quantitative composition

1 dose (0.5 mL) contains:

Pneumococcal polysaccharide serotype 1^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 3^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 4^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 5^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 6A^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 6B^1,2: 4.0 micrograms
Pneumococcal polysaccharide serotype 7F^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 9V^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 14^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 18C^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 19A^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 19F^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 22F^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 23F^1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 33F^1,2: 2.0 micrograms

¹ Conjugated to CRM₁₉₇ carrier protein. CRM₁₉₇ is a nontoxic mutant of diphtheria toxin (originating from Corynebacterium diphtheriae C7) expressed recombinantly in Pseudomonas fluorescens.
² Adsorbed on aluminium phosphate adjuvant.

1 dose (0.5 mL) contains 125 micrograms aluminium (Al³⁺) and approximately 30 micrograms CRM₁₉₇ carrier protein.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Pneumococcus, purified polysaccharides antigen

List of Excipients
Sodium chloride (NaCl) L-histidine Polysorbate 20 Water for injections For adjuvant, see section 2.

Pack sizes and marketing

0.5 mL suspension in pre-filled syringe (Type I glass) with a plunger stopper (latex-free bromobutyl rubber) and a tip cap (latex-free styrene-butadiene rubber).

Pack sizes of 1 or 10 pre-filled syringes, either without needles, with 1 separate needle, or with 2 separate needles.

Multipacks containing 50 (5 packs of 10) pre-filled syringes without needles.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/21/1591/001
EU/1/21/1591/002
EU/1/21/1591/003
EU/1/21/1591/004
EU/1/21/1591/005
EU/1/21/1591/006
EU/1/21/1591/007

Drugs

Drug	Countries
VAXNEUVANCE	Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, Romania, Turkey, United States

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