Overview
Iodixanol is a nonionic hydrophilic compound commonly used as a contrast agent during coronary angiography, particularly in individuals with renal dysfunction, as it is believed to be less toxic to the kidneys than most other intravascular contrast agents.
Background
Iodixanol is a nonionic hydrophilic compound commonly used as a contrast agent during coronary angiography, particularly in individuals with renal dysfunction, as it is believed to be less toxic to the kidneys than most other intravascular contrast agents.
Indication
Iodixanol is a contrast agent during coronary angiography.
Associated Conditions
No associated conditions information available.
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/05/08 | Phase 4 | Completed | |||
2012/04/18 | Phase 4 | UNKNOWN | Yong Huo | ||
2011/11/21 | Phase 4 | Completed | |||
2011/07/26 | Phase 4 | Terminated | |||
2011/06/20 | Phase 4 | Completed | |||
2011/03/30 | N/A | Terminated | |||
2010/08/25 | Not Applicable | Terminated | |||
2010/06/17 | Not Applicable | Completed | |||
2010/06/04 | Phase 4 | Terminated | |||
2010/06/04 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Iodixanol Injection | 国药准字HJ20181167 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字J20140156 | N/A | 注射剂 | 9/16/2019 | |
| Iodixanol Injection | 国药准字J20190026 | 化学药品 | 注射剂 | 11/28/2019 | |
| Iodixanol Injection | 国药准字HJ20191017 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字H20244413 | 化学药品 | 注射剂 | 7/9/2024 | |
| Iodixanol Injection | 国药准字H20244411 | 化学药品 | 注射剂 | 7/9/2024 | |
| Iodixanol Injection | 国药准字HJ20181165 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字H20174024 | 化学药品 | 注射剂 | 8/31/2020 | |
| Iodixanol Injection | 国药准字H20244409 | 化学药品 | 注射剂 | 7/9/2024 | |
| Iodixanol Injection | 国药准字J20200005 | 化学药品 | 注射剂 | 2/7/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VISIPAQUE iodixanol 27.5g/50mL (550mg/mL) injection vial | 49603 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 32.6g/50mL (652mg/mL) injection vial | 49594 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 97.8g/150mL (652mg/mL) injection bottle | 49598 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 65.2g/100mL (652mg/mL) injection bag | 49600 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 6.5g/10mL (652mg/mL) injection ampoule | 75927 | Medicine | A | 11/30/2000 | |
| VISIPAQUE iodixanol 13.0g/20mL (652mg/mL) injection ampoule | 75928 | Medicine | A | 11/30/2000 | |
| VISIPAQUE iodixanol 110g/200mL (550g/mL) injection bottle | 49606 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 26.1g/40mL (652mg/mL) injection ampoule | 75930 | Medicine | A | 11/30/2000 | |
| VISIPAQUE iodixanol 32.6g/50mL (652mg/mL) injection ampoule | 75926 | Medicine | A | 11/30/2000 | |
| VISIPAQUE iodixanol 5.5g/10mL (550mg/mL) injection ampoule | 75923 | Medicine | A | 11/30/2000 |