Overview
Fumazenil is an imidazobenzodiazepine derivative and a potent benzodiazepine receptor antagonist that competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex, thereby reversing the effects of benzodiazepine on the central nervous system.
Background
Fumazenil is an imidazobenzodiazepine derivative and a potent benzodiazepine receptor antagonist that competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex, thereby reversing the effects of benzodiazepine on the central nervous system.
Indication
For the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, and where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures. Also for the management of benzodiazepine overdose as an adjunct for appropriate supportive and symptomatic measures.
Associated Conditions
- Sedation caused by benzodiazepine
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/20 | Not Applicable | Completed | |||
2024/08/01 | Phase 1 | Not yet recruiting | Qianfoshan Hospital | ||
2024/07/22 | Phase 4 | Completed | Central South University | ||
2024/01/16 | Early Phase 1 | Not yet recruiting | Sichuan Provincial People's Hospital | ||
2023/07/11 | Not Applicable | Recruiting | |||
2023/01/12 | Phase 4 | Completed | |||
2022/07/21 | Phase 4 | Completed | |||
2022/06/28 | Not Applicable | Completed | |||
2022/05/31 | Not Applicable | Completed | |||
2022/05/19 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 0143-9683 | INTRAVENOUS | 0.1 mg in 1 mL | 11/20/2023 | |
| Sina Health Inc | 70385-2021 | INTRAVENOUS | 0.1 mg in 1 mL | 4/9/2017 | |
| Medical Purchasing Solutions, LLC | 71872-7008 | INTRAVENOUS | 0.1 mg in 1 mL | 10/13/2022 | |
| West-ward Pharmaceutical Corp. | 0641-6032 | INTRAVENOUS | 0.1 mg in 1 mL | 9/28/2011 | |
| Medical Purchasing Solutions, LLC | 71872-7038 | INTRAVENOUS | 0.1 mg in 1 mL | 5/31/2023 | |
| HF Acquisition Co. LLC, DBA HealthFirst | 51662-1254 | INTRAVENOUS | 0.1 mg in 1 mL | 1/28/2024 | |
| HF Acquisition Co. LLC, DBA Health First | 51662-1253 | INTRAVENOUS | 0.1 mg in 1 mL | 1/29/2024 | |
| REMEDYREPACK INC. | 70518-3456 | INTRAVENOUS | 0.1 mg in 1 mL | 1/11/2024 | |
| Fresenius Kabi USA, LLC | 63323-424 | INTRAVENOUS | 0.1 mg in 1 mL | 10/20/2017 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1579 | INTRAVENOUS | 0.1 mg in 1 mL | 6/28/2021 |
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 |
|---|---|---|---|---|---|
| FLUMAZENIL-BAXTER SOLUTION FOR INJECTION 0.5 MG/5 ML | SIN15209P | INJECTION, SOLUTION | 0.1 mg/mL | 4/11/2017 | |
| ANEXATE INJECTION 0.5 mg/5 ml | SIN01509P | INJECTION | 0.5 mg/5 ml | 5/25/1988 | |
| FLUMAZENIL KABI SOLUTION FOR INJECTION OR INFUSION 0.1MG/ML | SIN15610P | INJECTION, SOLUTION | 0.1mg/ml | 1/9/2019 | |
| FLUMAZENIL-HAMELN INJECTION 0.1MG/ML | SIN15750P | SOLUTION, STERILE | 0.1 mg per ml | 7/23/2019 | |
| FLUMAZENIL-BAXTER SOLUTION FOR INJECTION 1 MG/10 ML | SIN15210P | INJECTION, SOLUTION | 0.1 mg/mL | 4/11/2017 | |
| GP-FLUMAZENIL SOLUTION FOR I.V. INJECTION 0.5 MG/5 ML | SIN17223P | INJECTION, SOLUTION | 0.5 mg/5ml | 4/23/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Flumazenil Injection | 国药准字H20093463 | 化学药品 | 注射剂 | 3/15/2024 | |
| Flumazenil Injection | 国药准字H20063822 | 化学药品 | 注射剂 | 5/25/2020 | |
| Flumazenil Injection | 国药准字H20093461 | 化学药品 | 注射剂 | 3/15/2024 | |
| Flumazenil Injection | 国药准字H20020498 | 化学药品 | 注射剂 | 4/15/2020 | |
| Flumazenil Injection | 国药准字H20143151 | 化学药品 | 注射剂 | 7/14/2020 | |
| Flumazenil Injection | 国药准字H20243371 | 化学药品 | 注射剂 | 3/19/2024 | |
| Flumazenil Injection | 国药准字H20093462 | 化学药品 | 注射剂 | 3/15/2024 | |
| Flumazenil Injection | 国药准字H20093649 | 化学药品 | 注射剂 | 11/21/2023 | |
| Flumazenil Injection | 国药准字H20066462 | 化学药品 | 注射剂 | 10/28/2020 | |
| Flumazenil Injection | 国药准字H20234635 | 化学药品 | 注射剂 | 12/13/2023 |
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 |
|---|---|---|---|---|---|
| FLUMAZENIL KABI flumazenil 1mg/10mL solution for injection ampoules | 260017 | Medicine | A | 10/25/2016 | |
| GenRx Flumazenil flumazenil 0.5 mg / 5 mL solution for injection ampoule | 236673 | Medicine | A | 2/15/2016 | |
| ANEXATE 0.5mg/5mL injection | 13706 | Pharmaco Australia Ltd | Medicine | A | 8/23/1991 |
| Flumazenil-Baxter flumazenil 0.5 mg/5 mL solution for injection ampoule | 231405 | Medicine | A | 12/2/2015 | |
| APO-Flumazenil flumazenil 0.5 mg/ 5 mL solution for injection ampoule | 236674 | Medicine | A | 2/15/2016 | |
| Flumazenil-Baxter flumazenil 1 mg/10 mL solution for injection ampoule | 231406 | Medicine | A | 12/2/2015 | |
| FLUMAZENIL KABI flumazenil 0.5mg/5mL solution for injection ampoules | 260016 | Medicine | A | 10/25/2016 |