Overview
Gadoversetamide, marketed under the trade name OptiMARK, is a gadolinium compound used as a contrast agent in magnetic resonance imaging (MRI), particularly imaging of the brain, spine and liver.
Indication
Gadoversetamide is an MRI contrast agent used for MRI diagnostic procedures to provide increased enhancement and visualization of lesions of the brain, spine and liver, including tumors.
Associated Conditions
- Liver Lesions
- Spinal Cord Lesions
- Intracranial lesion
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/09/25 | Not Applicable | Completed | Daniel S. Berman | ||
2010/03/25 | Phase 4 | Completed |
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OPTIMARK | liebel-flarsheim canada inc | 02393158 | Solution - Intravenous | 330.9 MG / ML | N/A |
| OPTIMARK | liebel-flarsheim canada inc | 02393182 | Solution - Intravenous | 330.9 MG / ML | N/A |
| OPTIMARK | liebel-flarsheim canada inc | 02242986 | Solution - Intravenous | 330.9 MG / ML | 8/20/2001 |
| OPTIMARK | liebel-flarsheim canada inc | 02393166 | Solution - Intravenous | 330.9 MG / ML | N/A |
| OPTIMARK | liebel-flarsheim canada inc | 02393174 | Solution - Intravenous | 330.9 MG / ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OPTIMARK 500 MICROMOL/ml SOLUCION INYECTABLE EN UN VIAL | Mallinckrodt Deutschland Gmbh | 07398004 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not Commercialized |
| OPTIMARK 500 MICROMOL/ml SOLUCION INYECTABLE EN JERINGA PRECARGADA | Mallinckrodt Deutschland Gmbh | 07398011 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not Commercialized |
| OPTIMARK 500 MICROMOL/ml SOLUCION INYECTABLE EN UN VIAL | Mallinckrodt Deutschland Gmbh | 07398006 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not Commercialized |
| OPTIMARK 500 MICROMOL/ml SOLUCION INYECTABLE EN JERINGA PRECARGADA | Mallinckrodt Deutschland Gmbh | 07398009 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not Commercialized |
| OPTIMARK 500 MICROMOL/ml SOLUCION INYECTABLE EN UN VIAL | Mallinckrodt Deutschland Gmbh | 07398002 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not Commercialized |
| OPTIMARK 500 MICROMOL/ml SOLUCION INYECTABLE EN JERINGA PRECARGADA | Mallinckrodt Deutschland Gmbh | 07398013 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Not Commercialized |
| OPTIMARK 500 MICROMOL/ml SOLUCION INYECTABLE EN JERINGA PRECARGADA | Mallinckrodt Deutschland Gmbh | 07398007 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | 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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.