Overview
Artemether is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with lumefantrine 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.
Background
Artemether is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with lumefantrine 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
Artemether and lumefantrine 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
- Malaria
- Acute, uncomplicated Malaria caused by plasmodium falciparum
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/01/14 | Phase 2 | Completed | |||
2021/02/23 | Phase 4 | Completed | |||
2021/01/12 | Phase 4 | Recruiting | |||
2020/12/10 | Phase 2 | Completed | PATH | ||
2020/02/21 | Phase 1 | Suspended | |||
2018/04/27 | Phase 1 | Completed | |||
2016/04/19 | Phase 4 | Completed | Thierry Buclin | ||
2015/03/18 | Not Applicable | UNKNOWN | |||
2014/10/15 | Phase 1 | UNKNOWN | |||
2014/08/22 | Phase 1 | Completed |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
ORAL | 20 mg in 1 1 | 2017/09/15 | 0078-0568 | ||
ORAL | 20 mg in 1 1 | 2015/03/31 | 76413-154 |
EMA Approved Products
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval Number |
|---|
No HSA products found
No HSA products found for this drug
NMPA Approved Products
Product Name | Approval Number | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字H10900012 | 注射剂 | N/A | 0.5ml:40mg | Chemical Drug | Approved | 2020/08/12 | Domestic | ||
国药准字H10900011 | 注射剂 | N/A | 1ml:80mg | Chemical Drug | Approved | 2020/08/12 | Domestic | ||
国药准字H10920008 | 胶囊剂 | N/A | 40mg | Chemical Drug | Approved | 2020/07/17 | Domestic | ||
国药准字H10840006 | 胶囊剂 | N/A | 40mg | Chemical Drug | Approved | 2020/07/06 | Domestic | ||
国药准字H10920009 | 胶囊剂 | N/A | 100mg | Chemical Drug | Approved | 2020/07/06 | Domestic | ||
国药准字H10970018 | 片剂 | N/A | 50mg | Chemical Drug | Approved | 2020/07/17 | Domestic | ||
国药准字H20000014 | 片剂 | N/A | 25mg | Chemical Drug | Approved | 2020/07/06 | Domestic | ||
国药准字H10970019 | 片剂 | N/A | 40mg | Chemical Drug | Approved | 2020/07/06 | Domestic | ||
国药准字H20063203 | 胶囊剂(软胶囊) | N/A | 40mg | Chemical Drug | Approved | 2020/07/31 | Domestic |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Registration Date |
|---|
No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Registration Date | Ingredient |
|---|---|---|---|---|---|
158523 | Active | 2010/07/09 | artemether | ||
298287 | Active | 2018/04/13 | artemether | ||
158527 | Active | 2010/07/09 | artemether | ||
90011 | Active | 2002/07/24 | artemether |