Overview
Sulfur hexafluoride is an ultrasound contrast agent indicated for use •in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms •in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
Indication
Echocardiography: Sulfur hexafluoride is indicated for use in adult patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricularendocardial border. Ultrasonography of the Liver: Sulfur hexafluoride is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/07/12 | Phase 3 | Recruiting | Central Hospital, Nancy, France | ||
2023/01/23 | Phase 3 | Recruiting | |||
2022/12/13 | Phase 3 | Recruiting | |||
2019/07/05 | Phase 3 | UNKNOWN | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2018/03/26 | Phase 1 | Completed | St. Olavs Hospital | ||
2017/12/28 | Phase 3 | UNKNOWN | |||
2017/11/07 | Phase 3 | Completed | |||
2017/09/21 | Phase 3 | Terminated | |||
2017/08/01 | Phase 4 | Terminated | |||
2017/04/05 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
BRACCO DIAGNOSTICS INC | 0270-7097 | INTRAVESICAL, INTRAVENOUS | 60.7 mg in 1 mg | 1/10/2021 | |
BRACCO DIAGNOSTICS INC | 0270-7097 | INTRAVESICAL, INTRAVENOUS | 60.7 mg in 1 mg | 7/26/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 3/26/2001 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
SONOVUE POWDER FOR DISPERSION FOR INJECTION 8 microlitres/ml | SIN12349P | INJECTION, POWDER, FOR SOLUTION | 8 microlitres/ml | 7/18/2003 |
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. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SONOVUE | 02287684 | Powder For Suspension - Intravenous
,
Intravesical | 8 MCL / ML | 9/22/2016 |
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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