Overview
A complex of gadolinium with a chelating agent, diethylenetriamine penta-acetic acid (DTPA see pentetic acid), that is given to enhance the image in cranial and spinal MRIs. (From Martindale, The Extra Pharmacopoeia, 30th ed, p706)
Indication
For use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues as well as lesions with abnormal vascularity in the head and neck. Also used to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart).
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/04/10 | N/A | Completed | |||
2015/02/26 | Not Applicable | Withdrawn | |||
2014/10/30 | Early Phase 1 | Completed | Michael Vogelbaum, MD, PhD | ||
2014/03/06 | Not Applicable | Completed | |||
2014/02/07 | Not Applicable | Terminated | |||
2013/10/08 | Phase 4 | UNKNOWN | |||
2011/08/15 | Not Applicable | Withdrawn | |||
2011/06/20 | N/A | Completed | |||
2010/12/15 | Phase 3 | Completed | |||
2010/09/30 | Phase 3 | 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 |
|---|---|---|---|---|---|
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字H20253071 | 化学药品 | 注射剂 | 1/8/2025 | |
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字H10950231 | 化学药品 | 注射剂 | 11/13/2019 | |
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字H10950271 | 化学药品 | 注射剂 | 11/13/2019 | |
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字H10950272 | 化学药品 | 注射剂 | 11/13/2019 | |
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字H10950270 | 化学药品 | 注射剂 | 11/13/2019 | |
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字H10860002 | 化学药品 | 注射剂 | 9/21/2020 | |
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字H20013088 | 化学药品 | 注射剂 | 9/21/2020 | |
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字HJ20160597 | 化学药品 | 注射剂 | 7/5/2021 | |
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字HJ20160598 | 化学药品 | 注射剂 | 7/5/2021 | |
| Gadopentetic Acid Dimeglumine Salt Injection | 国药准字HJ20160593 | 化学药品 | 注射剂 | 7/5/2021 |
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 |
|---|---|---|---|---|---|
| MAGNEVIST gadopentetate dimeglumine 7.035 g/15mL injection vial | 48494 | Medicine | A | 5/4/1994 | |
| MAGNEVIST gadopentetate dimeglumine 4.69g/10mL injection syringe | 54671 | Medicine | A | 4/4/1996 | |
| MAGNEVIST gadopentetate dimeglumine 14.07g/30mL injection vial | 59542 | Medicine | A | 6/3/1997 | |
| MAGNEVIST gadopentetate dimeglumine 7.035g/15mL injection syringe | 54670 | Medicine | A | 4/4/1996 | |
| MAGNEVIST gadopentetate dimeglumine 46.9g/100mL injection bottle | 90883 | Medicine | A | 9/17/2002 | |
| MAGNEVIST gadopentetate dimeglumine 9.38g/20mL injection vial | 48495 | Medicine | A | 5/4/1994 | |
| MAGNEVIST gadopentetate dimeglumine 4.69g/10mL injection vial | 10697 | Medicine | A | 8/19/1991 | |
| MAGNEVIST gadopentetate dimeglumine 9.38g/20mL injection syringe | 54669 | Medicine | A | 4/4/1996 |
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