Overview
Iopamidol is a contrast agent developed by Bracco with nonionic, low-osmolar properties.
Background
Iopamidol is a contrast agent developed by Bracco with nonionic, low-osmolar properties.
Indication
本品用于腰、胸肌颈段脊髓造影，脑血管造影，周围动脉造影剂静脉造影；也用于心血管、冠状动脉、尿路、关节等的造影剂CT增强。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/13 | Phase 2 | Recruiting | |||
2022/08/05 | Not Applicable | UNKNOWN | Chongqing Emergency Medical Center | ||
2021/09/02 | N/A | Terminated | |||
2021/05/03 | Not Applicable | Completed | |||
2020/08/07 | Phase 1 | Terminated | Jennifer Lee Caswell-Jin | ||
2020/07/01 | N/A | Completed | |||
2018/12/19 | Phase 4 | Terminated | |||
2018/06/15 | Phase 4 | Completed | |||
2017/12/28 | Phase 4 | Completed | IRCCS Policlinico S. Donato | ||
2017/03/06 | Early Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bracco Diagnostics Inc | 0270-1316 | INTRAVENOUS | 755 mg in 1 mL | 3/2/2022 | |
| Bracco Diagnostics Inc | 0270-1411 | INTRATHECAL | 408 mg in 1 mL | 11/3/2022 | |
| Slate Run Pharmaceuticals | 70436-126 | INTRATHECAL | 612 mg in 1 mL | 10/9/2023 | |
| Bracco Diagnostics Inc | 0270-1412 | INTRATHECAL | 612 mg in 1 mL | 11/3/2022 | |
| BRACCO DIAGNOSTICS INC | 0270-1316 | INTRAVASCULAR | 755 mg in 1 mL | 11/17/2022 | |
| BRACCO DIAGNOSTICS INC | 0270-1315 | INTRAVASCULAR | 612 mg in 1 mL | 11/17/2022 | |
| Slate Run Pharmaceuticals, LLC | 70436-211 | INTRAVASCULAR | 408 mg in 1 mL | 10/10/2023 | |
| Bracco Diagnostics Inc | 0270-1315 | INTRAVENOUS | 612 mg in 1 mL | 3/2/2022 | |
| BRACCO DIAGNOSTICS INC | 0270-1314 | INTRAVASCULAR | 408 mg in 1 mL | 11/17/2022 | |
| BRACCO DIAGNOSTICS INC | 0270-1317 | INTRAVASCULAR | 510 mg in 1 mL | 11/17/2022 |
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 |
|---|---|---|---|---|---|
| IOPAMIRO 370 INJECTION 7.55 g/10 ml | SIN05907P | INJECTION | 7.55 g/10 ml | 5/22/1991 | |
| IOPAMIRO 300 INJECTION 6.12 g/10 ml | SIN05906P | INJECTION | 6.12 g/10 ml | 5/22/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Iopamidol Injection | 国药准字H20203203 | 化学药品 | 注射剂 | 5/12/2020 | |
| Iopamidol Injection | 国药准字H20184113 | 化学药品 | 注射剂 | 1/14/2020 | |
| Iopamidol Injection | 国药准字H20053384 | 化学药品 | 注射剂 | 2/21/2024 | |
| Iopamidol Injection | 国药准字H20233526 | 化学药品 | 注射剂 | 5/12/2023 | |
| Iopamidol Injection | 国药准字H20174099 | 化学药品 | 注射剂 | 1/14/2020 | |
| Iopamidol Injection | 国药准字H20053388 | 化学药品 | 注射剂 | 2/21/2024 | |
| Iopamidol Injection | 国药准字H20193196 | 化学药品 | 注射剂 | 5/14/2024 | |
| Iopamidol Injection | 国药准字H20237170 | 化学药品 | 注射剂 | 5/14/2024 | |
| Iopamidol Injection | 国药准字H20213528 | 化学药品 | 注射剂 | 6/18/2021 | |
| Iopamidol Injection | 国药准字H20073014 | 化学药品 | 注射剂 | 2/21/2024 |
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 |
|---|---|---|---|---|---|
| ISOVUE 300 61.24g/100mL injection vial | 47069 | Medicine | A | 12/6/1993 | |
| ISOVUE 370 37.76g/50mL injection vial | 47070 | Medicine | A | 12/6/1993 | |
| ISOVUE 300 30.62g/50mL injection vial | 47068 | Medicine | A | 12/6/1993 | |
| ISOVUE 370 151.04g/200mL injection vial | 47072 | Medicine | A | 12/6/1993 | |
| ISOVUE 370 75.52g/100mL injection vial | 47071 | Medicine | A | 12/6/1993 |