Overview
Lumefantrine is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with artemether for improved efficacy. This combination therapy exerts its effects against the erythrocytic stages of Plasmodium spp. and may be used to treat infections caused by P. falciparum and unidentified Plasmodium species, including infections acquired in chloroquine-resistant areas.
Indication
Lumefantrine and artemether combination therapy is indicated for the treatment of acute uncomplicated malaria caused by Plasmodium falciparum, including malaria acquired in chloroquine-resistant areas. May also be used to treat uncomplicated malaria when the Plasmodium species has not been identified. Indicated for use in adults and children greater than 5 kg.
Associated Conditions
- Uncomplicated Malaria caused by Plasmodium falciparum
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/05/06 | Phase 3 | Recruiting | |||
2020/12/19 | Phase 2 | Recruiting | |||
2020/09/25 | Phase 4 | Completed | University of Yaounde 1 | ||
2020/09/14 | Phase 2 | Recruiting | |||
2019/05/16 | Phase 1 | Completed | |||
2017/11/07 | Phase 2 | Completed | |||
2017/05/25 | Phase 2 | Completed | |||
2016/10/24 | Phase 1 | Completed | |||
2015/12/11 | Phase 1 | Completed | |||
2015/08/19 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0568 | ORAL | 120 mg in 1 1 | 9/15/2017 | |
| Central Texas Community Health Centers | 76413-154 | ORAL | 120 mg in 1 1 | 3/31/2015 |
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 |
|---|---|---|---|---|---|
| Lumefantrine Soft Capsules | 国药准字H10940019 | 化学药品 | 胶囊剂 | 7/6/2020 |
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 |
|---|---|---|---|---|---|
| RIAMET 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack | 158523 | Medicine | A | 7/9/2010 | |
| COARTEM artemether/lumefantrine 20 mg/120 mg tablet blister pack | 298287 | Medicine | A | 4/13/2018 | |
| COARTEM 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack | 158527 | Medicine | A | 7/9/2010 | |
| RIAMET artemether/lumefantrine 20 mg/120 mg tablet blister pack | 90011 | Medicine | A | 7/24/2002 |
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