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2018/08/15 | Phase 4 | Withdrawn | |||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 | 7/29/2025 | |
| Liebel-Flarsheim Company LLC | 0019-1333 | INTRA-ARTERIAL, INTRAVENOUS | 741 mg in 1 mL | 7/29/2025 | |
| Liebel-Flarsheim Company LLC | 0019-1332 | INTRA-ARTERIAL, INTRAVENOUS | 636 mg in 1 mL | 7/29/2025 | |
| 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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OPTIRAY 160 (ULTRAJECT) | tyco healthcare | 02035618 | Solution - Intravascular | 34 % | N/A |
| OPTIRAY 320 (ULTRAJECT) | 02035626 | Solution - Intravascular | 68 % / W/V | 2/5/1995 | |
| OPTIRAY 240 (ULTRAJECT) | 02035332 | Solution - Subarachnoidal
,
Intravascular | 51 % / W/V | 12/31/1996 | |
| OPTIRAY 350 | 02034484 | Solution - Intravascular | 74 % / W/V | 12/31/1993 | |
| OPTIRAY 160 | tyco healthcare | 01900838 | Solution - Intravenous | 34 % | 12/31/1992 |
| OPTIRAY 320 | 01900854 | Solution - Intravascular | 68 % / W/V | 12/31/1990 | |
| OPTIRAY 300 | 02034492 | Solution - Intravascular | 64 % / W/V | 3/3/1998 | |
| OPTIRAY 350 (ULTRAJECT) | 02079992 | Solution - Intravascular | 74 % / W/V | 12/31/1996 | |
| OPTIRAY 240 | 02225263 | Solution - Intravascular
,
Subarachnoidal | 51 % / W/V | 11/20/1996 | |
| OPTIRAY 300 (ULTRAJECT) | 02387441 | Solution - Intravascular | 64 % / W/V | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OPTIRAY 350 mg/ml SOLUCION INYECTABLE | 62069 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized | |
| OPTIRAY 320 mg/ml SOLUCION INYECTABLE | 58469 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized | |
| OPTIRAY ULTRAJECT 300 mg/ml SOLUCION INYECTABLE | 62070 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized | |
| OPTIRAY 300 mg/ml SOLUCION INYECTABLE | 62068 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized | |
| OPTIRAY ULTRAJECT 350 mg/ml SOLUCION INYECTABLE | 62067 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized | |
| OPTIRAY 240 mg/ml SOLUCION INYECTABLE | 58468 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not Commercialized | |
| OPTIRAY ULTRAJECT 240 mg/ml SOLUCION INYECTABLE | 60713 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not Commercialized | |
| OPTIRAY ULTRAJECT 320 mg/ml SOLUCION INYECTABLE | 60714 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized |
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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