Overview
Gadodiamide is a paramagnetic gadolinium-based contrast agent (GBCA) that is used in MR imaging procedures to assist in the visualization of blood vessels. It is intravenously injected and is commonly marketed under the trade name Omniscan.
Indication
For intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues.
Associated Conditions
- Stenosis
- Abnormal vascularity
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/03/01 | Phase 4 | UNKNOWN | The Central Hospital of Lishui City | ||
2020/05/04 | Phase 4 | Recruiting | |||
2009/05/25 | Phase 4 | Completed | |||
2005/09/21 | Phase 3 | Completed | |||
2005/09/21 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| GE Healthcare Inc. | 0407-0690 | INTRAVENOUS | 287 mg in 1 mL | 1/31/2024 | |
| GE Healthcare Inc. | 0407-0690 | INTRAVENOUS | 287 mg in 1 mL | 10/25/2018 | |
| GE Healthcare Inc. | 0407-0691 | INTRAVENOUS | 287 mg in 1 mL | 1/31/2024 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| OMNISCAN gadodiamide 11.48g/40mL injection ampoule | 72351 | Medicine | A | 1/7/2000 | |
| OMNISCAN gadodiamide 2.87g/10mL injection ampoule | 60112 | Medicine | A | 10/29/1997 | |
| OMNISCAN gadodiamide 5.74g/20mL injection ampoule | 60113 | Medicine | A | 10/29/1997 | |
| OMNISCAN Gadodiamide 14.35g/50mL injection ampoule | 72352 | Medicine | A | 1/7/2000 | |
| OMNISCAN gadodiamide 2.87g/10ml injection vial | 46378 | Medicine | A | 12/16/1993 | |
| OMNISCAN gadodiamide 4.305g/15ml injection ampoule | 60114 | Medicine | A | 10/29/1997 | |
| OMNISCAN gadodiamide 2.87g/10ml injection syringe | 74070 | Medicine | A | 5/31/2000 | |
| OMNISCAN gadodiamide 5.74g/20mL injection vial | 47380 | Medicine | A | 12/16/1993 | |
| OMNISCAN gadodiamide 1.435g/5mL injection vial | 62200 | Medicine | A | 12/18/1997 | |
| OMNISCAN gadodiamide 5.74g/20mL injection syringe | 74071 | Medicine | A | 5/31/2000 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OMNISCAN LIQ IV 287MG/ML | sanofi canada, inc. | 02093197 | Liquid - Intravenous | 287 MG / ML | 12/31/1994 |
| OMNISCAN | ge healthcare canada inc | 02172771 | Solution - Intravenous | 287 MG / ML | 3/25/1997 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OMNISCAN 0,5 mmol/ml SOLUCION INYECTABLE | Ge Healthcare Bio-Sciences, S.A.U. | 62699 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not Commercialized |
| OMNISCAN 0,5 mmol/ml SOLUCION INYECTABLE EN JERINGA PRECARGADA | Ge Healthcare Bio-Sciences, S.A.U. | 60331 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not 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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