Overview
Fibrinogen concentrate (human) is a hematological agent. It works by replacing a certain protein in the blood that helps with blood clotting. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. It is a physiological substrate for three enzymes: plasmin, factor XIIIa and thrombin. It is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Indication
Human fibrinogen is used for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. In combination with thrombin, it is used indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.
Associated Conditions
- Bleeding
- Dura Mater Nick Cut or Tear
- Surgical Bleeding
- Acute bleeding episodes
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/03 | Not Applicable | Not yet recruiting | Unidade Local de Saude do Arco Ribeirinho | ||
2024/02/12 | N/A | Recruiting | |||
2023/03/22 | Phase 2 | Completed | IRCCS Policlinico S. Donato | ||
2022/07/08 | Phase 3 | Recruiting | |||
2022/05/26 | Phase 4 | Recruiting | Brno University Hospital | ||
2022/03/29 | Phase 3 | Recruiting | |||
2021/10/25 | Phase 2 | Recruiting | |||
2020/10/26 | Not Applicable | Completed | |||
2020/06/16 | Phase 2 | Terminated | IRCCS Policlinico S. Donato | ||
2020/05/28 | Phase 4 | UNKNOWN | Antoni Sabaté Pes |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 0338-8701 | TOPICAL | 5.5 mg in 1 1 | 4/13/2022 | |
| Corza Medical GmbH | 83078-704 | TOPICAL | 5.5 mg in 1 1 | 9/1/2023 | |
| Baxter Healthcare Corporation | 0338-8702 | TOPICAL | 5.5 mg in 1 1 | 4/13/2022 | |
| Baxter Healthcare Corporation | 0338-8704 | TOPICAL | 5.5 mg in 1 1 | 4/13/2022 | |
| Corza Medical GmbH | 83078-701 | TOPICAL | 5.5 mg in 1 1 | 9/1/2023 | |
| Corza Medical GmbH | 83078-702 | TOPICAL | 5.5 mg in 1 1 | 9/1/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/8/2004 | ||
Withdrawn | 10/5/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FIBRYGA POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL | SIN15829P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1 g | 10/16/2019 | |
| HAEMOCOMPLETTAN P POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL | SIN15895P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 0.900-1.300 g/vial | 2/28/2020 | |
| TACHOSIL, MEDICATED SPONGE | SIN14441P | SPONGE | 5.5 mg per sq cm | 11/20/2013 | |
| VERASEAL SOLUTIONS FOR SEALANT, 80 mg/ml, 500 IU/ml | SIN16143P | SOLUTION | 80 mg/ml | 4/1/2021 | |
| TISSEEL FIBRIN SEALANT VH S/D (FROZEN) | SIN14707P | SOLUTION | 72-110 mg/ml | 12/22/2014 | |
| ARTISS SOLUTIONS FOR SEALANT, DEEP FROZEN | SIN14719P | SOLUTION | 72 – 110 mg/ml | 1/6/2015 | |
| BERIPLAST P COMBI-SET 1ML POWDERS AND SOLVENTS FOR SEALANT | SIN16775P | OTHER | 90mg | 5/10/2023 | |
| BERIPLAST P COMBI-SET 3ML POWDERS AND SOLVENTS FOR SEALANT | SIN16776P | OTHER | 270mg | 5/10/2023 |
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 |
|---|---|---|---|---|---|
| ARTISS fibrin sealant VH S/D 4 IU (frozen) solution for sealant syringe | 163515 | Medicine | A | 8/19/2010 | |
| TISSEEL VH S/D fibrin sealant syringe | 147141 | Medicine | A | 3/13/2009 | |
| TACHOSIL human fibrinogen 5.5mg/square cm and human thrombin 2.0IU/square cm medicated sponge blister pack | 176631 | Medicine | A | 3/22/2012 | |
| VeraSeal solutions for sealant 4 mL (Human fibrinogen 80 mg/mL syringe 2 ml / Human thrombin 500 IU/mL syringe 2 ml) | 336835 | Medicine | A | 11/3/2021 | |
| VeraSeal solutions for sealant 2 mL (Human fibrinogen 80 mg/mL syringe 1 mL / Human thrombin 500 IU/mL syringe 1 mL) | 335950 | Medicine | A | 11/2/2021 | |
| VeraSeal solutions for sealant 6 mL (Human fibrinogen 80 mg/mL syringe 3 ml / Human thrombin 500 IU/mL syringe 3 ml) | 336836 | Medicine | A | 11/3/2021 | |
| RIASTAP human fibrinogen 1g powder for injection vial | 162828 | Medicine | A | 8/9/2010 | |
| VeraSeal solutions for sealant 10 mL (Human fibrinogen 80 mg/mL syringe 5 ml / Human thrombin 500 IU/mL syringe 5 ml) | 336837 | Medicine | A | 11/3/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| VISTASEAL | 02514222 | Solution - Topical | 80 MG / 1 ML | 4/10/2023 | |
| TISSEEL KIT VH 5.0 | osterreichisches institut fur haemoderivate ges m.b.h. | 01974327 | Powder For Solution - Topical | 110 MG / ML | 12/31/1992 |
| TISSEEL KIT VH 2.0 | osterreichisches institut fur haemoderivate ges m.b.h. | 01949012 | Powder For Solution - Topical | 110 MG / ML | 12/31/1992 |
| TISSEEL KIT VH | osterreichisches institut fur haemoderivate ges m.b.h. | 00677558 | Jelly - Topical | 110 MG / PCK | 12/31/1986 |
| TACHOSIL | 02439042 | Patch - Topical | 5.5 MG / SQ CM | 9/18/2015 | |
| VISTASEAL | 02514230 | Solution - Topical | 160 MG / 2 ML | 1/19/2022 | |
| TACHOSIL | 02439026 | Patch - Topical | 5.5 MG / SQ CM | N/A | |
| EVICEL | 02348497 | Solution
,
Kit - Topical | 90 MG / ML | 3/1/2011 | |
| RIASTAP | csl behring canada inc | 02393352 | Powder For Solution - Intravenous | 1000 MG / VIAL | 1/31/2013 |
| TISSEEL KIT VH 5.0 | 02233275 | Liquid
,
Kit
,
Powder For Solution - Topical | 550 MG / 5 ML | 10/13/1998 |
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. | |||||
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