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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/10/01 | Phase 4 | UNKNOWN | |||
2018/09/14 | N/A | Completed | |||
2018/08/15 | Phase 4 | Withdrawn | |||
2017/11/06 | Phase 3 | Completed | Enrico Ammirati | ||
2017/04/18 | Phase 4 | Terminated | |||
2016/03/24 | Not Applicable | UNKNOWN | Chinese PLA General Hospital | ||
2015/04/01 | Not Applicable | Completed | Chinese PLA General Hospital | ||
2014/06/24 | Phase 3 | Completed | |||
2013/09/04 | Not Applicable | Withdrawn | VA Greater Los Angeles Healthcare System | ||
2013/07/25 | Early Phase 1 | Completed | Azienda Sanitaria Locale 9, Grosseto |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| GE Healthcare Inc. | 0407-2223 | INTRAVASCULAR | 320 mg in 1 mL | 4/30/2023 | |
| GE Healthcare Inc. | 0407-2222 | INTRAVASCULAR | 270 mg in 1 mL | 4/30/2023 | |
| GE Healthcare Inc. | 0407-2223 | INTRAVASCULAR | 320 mg in 1 mL | 3/1/2024 | |
| FRESENIUS KABI USA, LLC | 65219-381 | INTRAVASCULAR | 270 mg in 1 mL | 5/31/2022 | |
| GE Healthcare Inc. | 0407-2223 | INTRAVASCULAR | 320 mg in 1 mL | 4/30/2023 | |
| GE Healthcare Inc. | 0407-2222 | INTRAVASCULAR | 270 mg in 1 mL | 4/30/2023 | |
| FRESENIUS KABI USA, LLC | 65219-383 | INTRAVASCULAR | 320 mg in 1 mL | 5/31/2022 |
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 |
|---|---|---|---|---|---|
| VISIPAQUE INJECTION 320 mgI/ml | SIN08883P | INJECTION | 652 mg/ml | 8/28/1996 | |
| VISIPAQUE INJECTION 270 mgI/ml | SIN08882P | INJECTION | 550 mg/ml | 8/28/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Iodixanol Injection | 国药准字HJ20201004 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字HJ20191032 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字HJ20191016 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字H20247332 | 化学药品 | 注射剂 | 12/31/2024 | |
| Iodixanol Injection | 国药准字HJ20181170 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字HJ20181164 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字HJ20181169 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字HJ20191031 | 化学药品 | 注射剂 | 1/15/2024 | |
| Iodixanol Injection | 国药准字J20140157 | N/A | 注射剂 | 9/16/2019 | |
| Iodixanol Injection | 国药准字H20203628 | 化学药品 | 注射剂 | 12/2/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| VISIPAQUE INJ 320MG I/ML | N/A | N/A | N/A | 9/5/1998 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VISIPAQUE iodixanol 110g/200mL (550mg/mL) injection bag | 49609 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 13.0g/20mL (652mg/mL) injection ampoule | 154370 | Medicine | A | 10/29/2008 | |
| VISIPAQUE iodixanol 82.5g/150mL (550mg/mL) injection bag | 49608 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 27.5g/50mL (550mg/mL) injection ampoule | 75925 | Medicine | A | 11/30/2000 | |
| VISIPAQUE iodixanol 11.0g/20mL (550mg/mL) injection vial | 154369 | Medicine | A | 10/29/2008 | |
| VISIPAQUE iodixanol 130.4g/200mL (652mg/mL) injection bag | 49602 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 65.2g/100mL (652mg/mL) injection bottle | 49597 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 97.8g/150mL (652mg/mL) injection bag | 49601 | Medicine | A | 6/27/1995 | |
| VISIPAQUE iodixanol 11.0g/20mL (550mg/mL) injection vial | 75924 | Medicine | A | 11/30/2000 | |
| VISIPAQUE iodixanol 22.0g/40mL (550mg/mL) injection ampoule | 75929 | Medicine | A | 11/30/2000 |