Overview
Manganese is a transition metal with a molar mass of 54.94g/mol. Manganese is considered critical for human health, and plays important roles in development, metabolism, and the antioxidant system. That said, excessive manganese intake is associated with manganism, a neurodegenerative disorder that causes dopaminergic neuronal death and parkinsonian-like symptoms.
Indication
Indicated for use as a supplement to intravenous solutions given for Total Parenteral Nutrition (TPN). Administration helps to maintain plasma levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/05/05 | Phase 1 | UNKNOWN | Chinese PLA General Hospital | ||
2019/07/01 | Phase 1 | UNKNOWN | Chinese PLA General Hospital | ||
2019/06/19 | Phase 1 | UNKNOWN | Chinese PLA General Hospital | ||
2019/06/18 | Phase 1 | UNKNOWN | Chinese PLA General Hospital | ||
2019/06/18 | Phase 2 | Completed | Chinese PLA General Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Nutritional Specialties, Inc. | 83027-0036 | ORAL | 12 [hp_X] in 1 mL | 4/14/2025 | |
Exeltis USA, Inc. | 0642-0207 | ORAL | 1.5 mg in 1 1 | 1/2/2023 | |
Deseret Biologicals, Inc. | 43742-2244 | ORAL | 12 [hp_X] in 1 mL | 5/27/2025 | |
Deseret Biologicals, Inc. | 43742-2259 | ORAL | 16 [hp_X] in 1 mL | 4/8/2025 | |
Parasitology Center Inc. | 70321-0003 | ORAL | 15 [hp_X] in 1 mL | 5/22/2025 | |
Deseret Biologicals, Inc. | 43742-1312 | ORAL | 8 [hp_X] in 1 mL | 5/27/2025 | |
King Bio Inc. | 57955-5276 | ORAL | 10 [hp_X] in 59 mL | 5/19/2025 | |
Parasitology Center, Inc. | 70321-0002 | ORAL | 16 [hp_C] in 1 mL | 5/22/2025 | |
Dr. Donna Restivo DC | 62185-0062 | ORAL | 8 [hp_X] in 1 mL | 5/23/2025 | |
Hospira, Inc. | 0409-4091 | INTRAVENOUS | 0.1 mg in 1 mL | 12/6/2023 |
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 |
---|---|---|---|---|---|
ADDAVEN CONCENTRATE FOR SOLUTION FOR INFUSION | SIN15302P | INFUSION, SOLUTION CONCENTRATE | 19.79 mcg/ml | 7/24/2017 | |
PEDITRACE CONCENTRATE FOR PARENTERAL INFUSION | SIN08899P | INJECTION | 3.6 mcg/ml | 9/4/1996 |
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 |
---|---|---|---|---|---|
OPTHALMIC LABS COPPER MANGANESE CHROMIUM injection | 23097 | Medicine | A | 10/14/1991 | |
ADDAVEN concentrated injection ampoule | 244493 | Medicine | A | 7/29/2016 | |
Meo Healthcare Cal-D Plus | 142223 | Medicine | A | 7/17/2007 | |
ARTHROSTRONG tablets | 133590 | Medicine | A | 12/11/2006 | |
FreeMovement | 161667 | Medicine | A | 5/8/2009 | |
Vitamin C with Hesperidin Complex | 159838 | Medicine | A | 3/6/2009 | |
ARTHRO-EZE | 128491 | Medicine | A | 6/1/2006 |
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