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HSA Approval

VAXNEUVANCE® Suspension for Injection

SIN16944P

VAXNEUVANCE® Suspension for Injection

VAXNEUVANCE® Suspension for Injection

February 7, 2024

MSD PHARMA (SINGAPORE) PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantMSD PHARMA (SINGAPORE) PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SUSPENSION

INTRAMUSCULAR

Medical Information

J07AL02

pneumococcus, purified polysaccharides antigen conjugated

Manufacturer Information

MSD PHARMA (SINGAPORE) PTE. LTD.

MSD International GmbH T/A MSD Ireland (Carlow)

Active Ingredients

(MBC) Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 9 v conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 1 conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 14 conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 23 f conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 3 conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 5 conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 6 a conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 7 f conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 18 c conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 19 a conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 19 f conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 22 f conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 33 f conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197

2μg

(mbc) pneumococcal polysaccharide serotype 4 conjugated to crm 197

(MBC) Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197

4μg

(mbc) pneumococcal polysaccharide serotype 6 b conjugated to crm 197

Documents

Package Inserts

VAxneuvance approved PI February 2024.pdf

Approved: February 7, 2024

Download

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