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 11,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 31,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 41,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 51,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 6A1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 6B1,2: 4.0 micrograms
Pneumococcal polysaccharide serotype 7F1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 9V1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 141,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 18C1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 19A1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 19F1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 22F1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 23F1,2: 2.0 micrograms
Pneumococcal polysaccharide serotype 33F1,2: 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 Estonia, Finland, Ireland, Japan, Poland, Romania, Turkey, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.