Overview
Protein S human is a vitamin K-dependent plasma glycoprotein which has antcoagulant properties . It serves as a negative feedback mechanism in the coagulation cascade.
Indication
For use in the emergency reversal of coagulation factor deficiency in patients recieving vitamin K antagonist therapy . Protein S is administered as part of a cocktail containing several other coagulation factors.
Associated Conditions
- Vitamin K antagonist induced major bleeding
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 |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU | SIN14933P | INJECTION, POWDER, FOR SOLUTION | 240 - 640 IU/vial | 1/28/2016 |
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 |
|---|---|---|---|---|---|
| BERIPLEX AU human prothrombin complex 250 IU powder for injection vial | 328514 | Medicine | A | 7/7/2020 | |
| BERIPLEX P/N human prothrombin complex 250 IU powder for injection vial | 156330 | Medicine | A | 2/5/2010 | |
| BERIPLEX AU human prothrombin complex 1000 IU powder for injection vial | 328516 | Medicine | A | 7/7/2020 | |
| BERIPLEX AU human prothrombin complex 500 IU powder for injection vial | 328515 | Medicine | A | 7/7/2020 | |
| BERIPLEX P/N human prothrombin complex 500 IU powder for injection vial | 156459 | Medicine | A | 2/5/2010 | |
| PRONATIV human prothrombin complex powder for injection vial and solution for injection vial | 129151 | Octapharma Australia Pty Ltd | Medicine | A | 10/12/2007 |
| BERIPLEX P/N human prothrombin complex 1000 IU powder for injection vial | 228338 | Medicine | A | 8/5/2015 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OCTAPLEX | octapharma pharmazeutika produktionsges m b h | 02294664 | Kit
,
Powder For Solution - Intravenous | 640 UNIT / VIAL | 7/8/2008 |
| BERIPLEX P/N 1000 | csl behring canada inc | 02410826 | Powder For Solution - Intravenous | 1360 UNIT | 11/21/2013 |
| BERIPLEX P/N 500 | csl behring canada inc | 02359251 | Powder For Solution - Intravenous | 680 UNIT | 7/28/2011 |
| OCTAPLEX | octapharma pharmazeutika produktionsges m b h | 02434970 | Powder For Solution
,
Kit - Intravenous | 1280 UNIT / VIAL | 8/11/2015 |
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.