Overview
Streptococcus pneumoniae type 6b capsular polysaccharide antigen is a vaccine that contains highly purified capsular polysaccharides from the invasive pneumococcal type 6b of Streptococcus pneumoniae. It is an active immunization for intramuscular or subcutaneous injection against pneumococcal disease such as pneumococcal pneumonia and pneumococcal bacteremia.
Indication
No indication information available.
Associated Conditions
- Pneumococcal Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/03/08 | Phase 3 | Active, not recruiting | Fosun Adgenvax Biopharmaceutical Co.,Ltd. | ||
2013/08/21 | Phase 4 | Completed | |||
2013/07/04 | Phase 3 | Completed | Karolinska University Hospital | ||
2010/08/04 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 12/9/2009 | ||
Authorised | 3/29/2009 | ||
Authorised | 2/14/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
APEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML | SIN16648P | INJECTION, SUSPENSION | 4.4 μg/0.5ml | 11/30/2022 | |
Prevenar 13 Suspension For Injection | SIN13824P | INJECTION, SUSPENSION | 4.4mcg | 7/2/2010 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
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