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Streptococcus pneumoniae type 19A capsular polysaccharide diphtheria CRM197 protein conjugate antigen

Generic Name
Streptococcus pneumoniae type 19A capsular polysaccharide diphtheria CRM197 protein conjugate antigen
Brand Names
Prevnar 13, Prevnar 20, Vaxneuvance
Drug Type
Biotech
Unique Ingredient Identifier
B970MQT365

Overview

Streptococcus pneumoniae type 19a capsular polysaccharide diphtheria CRM197 protein conjugate antigen is a sterile vaccine that contains saccharides of the capsular antigens of Streptococcus pneumoniae serotype 19A individually conjugated to the CRM197 protein, a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197). The saccharides in the vaccine are prepared from purified polysaccharides that are chemically activated then conjugated to the protein carrier CRM197 to form the glycoconjugate.

Background

Streptococcus pneumoniae type 19a capsular polysaccharide diphtheria CRM197 protein conjugate antigen is a sterile vaccine that contains saccharides of the capsular antigens of Streptococcus pneumoniae serotype 19A individually conjugated to the CRM197 protein, a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197). The saccharides in the vaccine are prepared from purified polysaccharides that are chemically activated then conjugated to the protein carrier CRM197 to form the glycoconjugate.

Indication

No indication information available.

Associated Conditions

  • Invasive Infection caused by Streptococcus pneumoniae serotype 19A

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
Wyeth Pharmaceutical Division of Wyeth Holdings LLC
INTRAMUSCULAR
2.2 ug in 0.5 mL
2025/04/18
0005-2000
INTRAMUSCULAR
2.2 ug in 0.5 mL
2017/08/29
50090-1944

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
INJECTION, SUSPENSION
3 μg PS19F; 3.33-6.00 μg DT/dose
2010/03/19
SIN13775P

NMPA Approved Products

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Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import

No NMPA products found

No NMPA products found for this drug

PPB Approved Products

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Registration Code
Company
Category
Sale Type
Reg. Date

No PPB products found

No PPB products found for this drug

TGA Approved Products

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ARTG ID
Sponsor
Status
Reg. Date
Ingredient

No TGA products found

No TGA products found for this drug

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