Overview
A non-depolarizing neuromuscular blocking agent with short duration of action. Its lack of significant cardiovascular effects and its lack of dependence on good kidney function for elimination provide clinical advantage over alternate non-depolarizing neuromuscular blocking agents.
Indication
For use, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/07/05 | Not Applicable | UNKNOWN | |||
2022/02/15 | Not Applicable | UNKNOWN | |||
2021/10/28 | Early Phase 1 | Completed | |||
2016/12/29 | Not Applicable | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Meitheal Pharmaceuticals Inc. | 71288-702 | INTRAVENOUS | 10 mg in 1 mL | 9/30/2019 | |
| AuroMedics Pharma LLC | 55150-217 | INTRAVENOUS | 100 mg in 10 mL | 2/14/2022 | |
| Meitheal Pharmaceuticals Inc. | 71288-701 | INTRAVENOUS | 10 mg in 1 mL | 9/30/2019 | |
| Hospira, Inc. | 0409-1109 | INTRAVENOUS | 10 mg in 1 mL | 11/1/2022 | |
| Hospira, Inc. | 0409-1105 | INTRAVENOUS | 10 mg in 1 mL | 11/1/2022 | |
| AuroMedics Pharma LLC | 55150-216 | INTRAVENOUS | 50 mg in 5 mL | 5/30/2022 |
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 |
|---|---|---|---|---|---|
| Atracurium-hameln Injection 10mg/ml | SIN14533P | INJECTION, SOLUTION | 10.0 mg per ml | 4/1/2014 | |
| TRACRIUM INJECTION 10 mg/ml | SIN06058P | INJECTION | 10 mg/ml | 5/22/1991 | |
| NOTRIXUM 50 INJECTION 50MG/5ML | SIN16945P | INJECTION, SOLUTION | 50mg/5ml | 2/7/2024 | |
| ATRACURIUM LABATEC IV SOLUTION FOR INJECTION 10MG/ML | SIN14836P | INJECTION, SOLUTION | 10 mg/ml | 8/28/2015 |
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 |
|---|---|---|---|---|---|
| NOTRIXUM SOLUTION FOR INJECTION/INFUSION 50MG/5ML | N/A | N/A | N/A | 2/11/2025 | |
| NOTRIXUM SOLUTION FOR INJECTION/INFUSION 25MG/2.5ML | N/A | N/A | N/A | 2/11/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TRACRIUM atacurium besilate 50mg/5mL injection ampoules | 39289 | Medicine | A | 6/12/1992 | |
| DBL ATRACURIUM BESYLATE 25mg/2.5mL injection ampoule | 57992 | Medicine | A | 12/19/1996 | |
| ATRACURIUM BESILATE MEDICIANZ atracurium besilate 50 mg/5 mL solution for injection ampoule | 400349 | Medicine | A | 11/20/2023 | |
| ATRACURIUM BESILATE MEDSURGE atracurium besilate 25 mg/2.5 mL solution for injection ampoule | 400346 | Medicine | A | 11/20/2023 | |
| Hospira Atracurium Besilate 10 mg/mL Solution for Injection 250 mg/25 mL vial | 314817 | Medicine | A | 2/26/2019 | |
| Hospira Atracurium Besilate 10 mg/mL Injection 250 mg/25 mL vial | 125094 | Medicine | A | 1/17/2006 | |
| TRACRIUM atracurium besilate 25mg/2.5mL injection ampoule | 11008 | Medicine | A | 8/2/1991 | |
| Hospira Atracurium besilate Injection 100mg/10mL vial | 59210 | Medicine | A | 3/6/1997 | |
| Atracurium besilate Injection 25 mg/2.5 mL vial | 141124 | Medicine | A | 6/27/2007 | |
| ATRACURIUM BESILATE MEDICIANZ atracurium besilate 25 mg/2.5 mL solution for injection ampoule | 400348 | Medicine | A | 11/20/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ATRACURIUM BESYLATE INJECTION | 02236759 | Liquid - Intravenous | 10 MG / ML | 1/20/1998 | |
| TRACRIUM | 00675210 | Liquid - Intravenous | 10 MG / ML | 12/31/1990 | |
| ATRACURIUM - (FOR SINGLE DOSE ) | ivax pharmaceuticals incorporated | 02240300 | Solution - Intravenous | 10 MG / ML | N/A |
| ATRACURIUM BESYLATE INJECTION | ABBOTT LABORATORIES, LIMITED | 02229757 | Liquid - Intravenous | 10 MG / ML | 2/11/1998 |
| ATRACURIUM - (FOR MULTIPLE DOSE VIAL - WITH PRESERVATIVE) | ivax pharmaceuticals incorporated | 02240303 | Solution - Intravenous | 10 MG / ML | N/A |
| ATRACURIUM BESYLATE INJECTION | hospira healthcare ulc | 02236319 | Solution - Intravenous | 10 MG / ML | 7/13/1998 |
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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