Iodixanol

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.

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
Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography	2013/05/08	NCT01848899	Phase 4	Completed	NYU Langone Health
Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction	2012/04/18	NCT01580046	Phase 4	UNKNOWN	Yong Huo
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography	2011/11/21	NCT01475097	Phase 4	Completed	GE Healthcare
Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients	2011/07/26	NCT01402219	Phase 4	Terminated	Guangdong Provincial People's Hospital
Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis	2011/06/20	NCT01376089	Phase 4	Completed	GE Healthcare
Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection	2011/03/30	NCT01326364	N/A	Terminated	Stanford University
Pulmonary Interstitial Lymphography in Early Stage Lung Cancer	2010/08/25	NCT01188486	Not Applicable	Terminated	Stanford University
DynaCT in Preoperative Imaging Before Insertion of Stentgraft	2010/06/17	NCT01146639	Not Applicable	Completed	Norwegian University of Science and Technology
Kidney Damage In Patients With Severe Fall In eGFR	2010/06/04	NCT01136915	Phase 4	Terminated	Bracco Diagnostics, Inc
Kidney Damage in Patients With Moderate Fall in eGFR	2010/06/04	NCT01136876	Phase 4	Completed	Bracco Diagnostics, Inc

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	GE Healthcare AS	国药准字HJ20181167	化学药品	注射剂	1/15/2024
Iodixanol Injection	GE Healthcare AS	国药准字J20140156	N/A	注射剂	9/16/2019
Iodixanol Injection	GE Healthcare AS	国药准字J20190026	化学药品	注射剂	11/28/2019
Iodixanol Injection	GE Healthcare AS	国药准字HJ20191017	化学药品	注射剂	1/15/2024
Iodixanol Injection	通用电气药业（上海）有限公司	国药准字H20244413	化学药品	注射剂	7/9/2024
Iodixanol Injection	通用电气药业（上海）有限公司	国药准字H20244411	化学药品	注射剂	7/9/2024
Iodixanol Injection	GE Healthcare AS	国药准字HJ20181165	化学药品	注射剂	1/15/2024
Iodixanol Injection	江苏恒瑞医药股份有限公司	国药准字H20174024	化学药品	注射剂	8/31/2020
Iodixanol Injection	通用电气药业（上海）有限公司	国药准字H20244409	化学药品	注射剂	7/9/2024
Iodixanol Injection	GE Healthcare AS	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	GE Healthcare Australia Pty Ltd	Medicine	A	6/27/1995
VISIPAQUE iodixanol 32.6g/50mL (652mg/mL) injection vial	49594	GE Healthcare Australia Pty Ltd	Medicine	A	6/27/1995
VISIPAQUE iodixanol 97.8g/150mL (652mg/mL) injection bottle	49598	GE Healthcare Australia Pty Ltd	Medicine	A	6/27/1995
VISIPAQUE iodixanol 65.2g/100mL (652mg/mL) injection bag	49600	GE Healthcare Australia Pty Ltd	Medicine	A	6/27/1995
VISIPAQUE iodixanol 6.5g/10mL (652mg/mL) injection ampoule	75927	GE Healthcare Australia Pty Ltd	Medicine	A	11/30/2000
VISIPAQUE iodixanol 13.0g/20mL (652mg/mL) injection ampoule	75928	GE Healthcare Australia Pty Ltd	Medicine	A	11/30/2000
VISIPAQUE iodixanol 110g/200mL (550g/mL) injection bottle	49606	GE Healthcare Australia Pty Ltd	Medicine	A	6/27/1995
VISIPAQUE iodixanol 26.1g/40mL (652mg/mL) injection ampoule	75930	GE Healthcare Australia Pty Ltd	Medicine	A	11/30/2000
VISIPAQUE iodixanol 32.6g/50mL (652mg/mL) injection ampoule	75926	GE Healthcare Australia Pty Ltd	Medicine	A	11/30/2000
VISIPAQUE iodixanol 5.5g/10mL (550mg/mL) injection ampoule	75923	GE Healthcare Australia Pty Ltd	Medicine	A	11/30/2000

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