Iobitridol

Overview

Iobitridol has been used in trials studying the diagnostic of Diagnostic Imaging, Coronary Artery Disease, Type 2 Diabetes Mellitus, and Coronary Atherosclerosis.

Indication

用于Ｘ线尿路静脉造影、动脉造影、头颅和全身计算机断层扫描（ＣＴ）、静脉血管数字减影。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship	2013/07/25	NCT01908309	Early Phase 1	Completed	Azienda Sanitaria Locale 9, Grosseto
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography	2010/12/07	NCT01255722	Phase 4	Completed	Guerbet
Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis	2010/12/06	NCT01254552	Phase 4	Completed	Guerbet
A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography	2006/09/29	NCT00382317	Phase 4	Completed	Guerbet
A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications	2006/07/04	NCT00347022	Phase 4	Completed	Guerbet

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
XENETIX 350 INJECTION 350 mgi/ml	GUERBET	SIN08867P	INJECTION	76.78g	8/22/1996
XENETIX 300 INJECTION 300 mgi/ml	GUERBET	SIN08866P	INJECTION	65.81 g	8/22/1996

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Iobitridol Injection	LIEBEL-FLARSHEIM COMPANY LLC	国药准字HJ20160377	化学药品	注射剂	6/8/2021
Iobitridol Injection	LIEBEL-FLARSHEIM COMPANY LLC	国药准字HJ20160373	化学药品	注射剂	6/8/2021
Iobitridol Injection	重庆圣华曦药业股份有限公司	国药准字H20249462	化学药品	注射剂	12/1/2024
Iobitridol Injection	LIEBEL-FLARSHEIM COMPANY LLC	国药准字HJ20160376	化学药品	注射剂	6/8/2021
Iobitridol Injection	重庆圣华曦药业股份有限公司	国药准字H20249463	化学药品	注射剂	12/1/2024
Iobitridol Injection	LIEBEL-FLARSHEIM COMPANY LLC	国药准字HJ20160375	化学药品	注射剂	6/8/2021
Iobitridol Injection	LIEBEL-FLARSHEIM COMPANY LLC	国药准字HJ20160374	化学药品	注射剂	6/8/2021

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
No TGA approvals found for this drug.

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