Overview
Streptococcus pneumoniae type 1 capsular polysaccharide diphtheria CRM197 protein conjugate antigen is a sterile vaccine that contains saccharides of the capsular antigens of Streptococcus pneumoniae serotype 1 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 Streptococcal Infection
- Otitis Media (OM) caused by Streptococcus Pneumoniae
- Invasive Infection caused by Streptococcus pneumoniae serotype 1
- Pneumonia caused by Streptococcus Pneumoniae
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-1944 | INTRAMUSCULAR | 2.2 ug in 0.5 mL | 8/29/2017 | |
| A-S Medication Solutions | 50090-6026 | INTRAMUSCULAR | 2.2 ug in 0.5 mL | 8/13/2025 | |
| Wyeth Pharmaceutical Division of Wyeth Holdings LLC | 0005-2000 | INTRAMUSCULAR | 2.2 ug in 0.5 mL | 4/18/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Synflorix Suspension for Injection (Prefilled Syringe) | SIN13775P | INJECTION, SUSPENSION | 1 μg PS1; 1.11-1.67 μg PD/dose | 3/19/2010 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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