Overview
Ioversol is a non-ionic compound with a tri-iodinated benzene ring used as a contrast dye in diagnostic procedures to visualize different types of organs and tissues. Iodine has a high atomic density, which gives it the ability to attenuate X-rays. The intravascular administration of iodine compounds, such as ioversol, enhances the contrast between vessels in the path of the flow of the contrast medium and normal tissue, allowing the visualization of internal structures. Ioversol is a highly hydrophilic agent considered to be generally safe; however, serious adverse reactions have been reported due to the inadvertent intrathecal administration of ioversol, which is only indicated for intra-arterial and intravenous use. Ioversol was approved by the FDA in 1989 and is currently indicated for computed tomographic (CT) imaging and contrast enhancement in peripheral arteriography, coronary arteriography, and left ventriculography.
Indication
As the product Optiray 300, the intra-arterial use of ioversol is indicated for cerebral arteriography and peripheral arteriography in adults, while its intravenous use is indicated for CT imaging of the head and body, venography, and intravenous excretory urography in adults. As the product Optiray 320, the intra-arterial use of ioversol is indicated for cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography in adults, and angiocardiography in pediatic patients. The intravenous use of this product is indicated for CT imaging of the head and body, venography, and intravenous excretory urography in adults and CT imaging of the head and body, and intravenous excretory urography in pediatric patients. As the product Optiray 350, the intra-arterial use of ioversol is indicated for peripheral arteriography coronary arteriography, and left ventriculography in adults, and angiocardiography in pediatic patients. The intravenous use of this product is indicated for CT imaging of the head and body, venography, intravenous excretory urography, and intravenous digital subtraction angiography (IV-DSA) in adults and CT imaging of the head and body, and intravenous excretory urography in pediatric patients.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/08/15 | Phase 4 | Withdrawn | |||
2014/04/17 | Early Phase 1 | Completed | |||
2008/11/19 | Phase 4 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Liebel-Flarsheim Company LLC | 0019-1323 | INTRA-ARTERIAL, INTRAVENOUS | 678 mg in 1 mL | 11/18/2017 | |
| Liebel-Flarsheim Company LLC | 0019-1333 | INTRA-ARTERIAL, INTRAVENOUS | 741 mg in 1 mL | 11/18/2017 | |
| Liebel-Flarsheim Company LLC | 0019-1332 | INTRA-ARTERIAL, INTRAVENOUS | 636 mg in 1 mL | 11/18/2017 | |
| Liebel-Flarsheim Company LLC | 0019-1333 | INTRA-ARTERIAL, INTRAVENOUS | 741 mg in 1 mL | 11/23/2020 | |
| Liebel-Flarsheim Company LLC | 0019-1333 | INTRA-ARTERIAL, INTRAVENOUS | 741 mg in 1 mL | 2/5/2023 | |
| Liebel-Flarsheim Company LLC | 0019-1332 | INTRA-ARTERIAL, INTRAVENOUS | 636 mg in 1 mL | 11/23/2020 | |
| Liebel-Flarsheim Company LLC | 0019-1323 | INTRA-ARTERIAL, INTRAVENOUS | 678 mg in 1 mL | 2/5/2023 | |
| Liebel-Flarsheim Company LLC | 0019-1323 | INTRA-ARTERIAL, INTRAVENOUS | 678 mg in 1 mL | 11/23/2020 | |
| Liebel-Flarsheim Company LLC | 0019-1332 | INTRA-ARTERIAL, INTRAVENOUS | 636 mg in 1 mL | 2/5/2023 |
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 |
|---|---|---|---|---|---|
| OPTIRAY 350 INJECTION 74% | SIN07748P | INJECTION | 741 mg/ml | 6/15/1994 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ioversol Injection | 国药准字HJ20150572 | 化学药品 | 注射剂 | 9/9/2020 | |
| Ioversol Injection | 国药准字H20243653 | 化学药品 | 注射剂 | 4/30/2024 | |
| Ioversol Injection | H20150340 | 化学药品 | 注射剂 | 7/26/2019 | |
| Ioversol Injection | 国药准字HJ20150567 | 化学药品 | 注射剂 | 9/9/2020 | |
| Ioversol Injection | H20150333 | 化学药品 | 注射剂 | 7/26/2019 | |
| Ioversol Injection | 国药准字HJ20150566 | 化学药品 | 注射剂 | 9/9/2020 | |
| Ioversol Injection | 国药准字H20234353 | 化学药品 | 注射剂 | 10/24/2023 | |
| Ioversol Injection | 国药准字HJ20150338 | 化学药品 | 注射剂 | 5/30/2024 | |
| Ioversol Injection | 国药准字HJ20150332 | 化学药品 | 注射剂 | 5/30/2024 | |
| Ioversol Injection | H20150341 | 化学药品 | 注射剂 | 7/26/2019 |
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 |
|---|---|---|---|---|---|
| OPTIRAY 320 Ioversol 20.34g/30mL injection | 49421 | Medicine | A | 7/11/1994 | |
| OPTIRAY 350 ULTRAJECT Ioversol 74% w/v injection | 51796 | Medicine | A | 4/21/1995 | |
| OPTIRAY 350 Ioversol 92.6g/125mL injection syringe | 61984 | Medicine | A | 11/10/1997 | |
| OPTIRAY 320 Ioversol 135.6g/200mL injection vial | 49425 | Medicine | A | 7/11/1994 | |
| OPTIRAY 320 Ioversol 33.9 g/50 mL injection | 46641 | Medicine | A | 10/7/1993 | |
| OPTIRAY 350 Ioversol 74% w/v injection syringe | 70059 | Medicine | A | 7/16/1999 | |
| OPTIRAY 350 Ioversol 74% w/v injection | 47997 | Medicine | A | 7/11/1994 | |
| OPTIRAY 320 Ioversol 67.8g/100mL injection vial | 49423 | Medicine | A | 7/11/1994 | |
| OPTIRAY 320 Ioversol 33.9g/50mL injection | 49422 | Medicine | A | 7/11/1994 | |
| OPTIRAY 320 ULTRAJECT ioversol 50.8g/75mL injection syringe | 73580 | Medicine | A | 4/6/2000 |
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