This brand name is authorized in Nigeria.
The drug MALETHER PLUS contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
C7D6T3H22J - ARTEMETHER
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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. |
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2
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UNII
F38R0JR742 - LUMEFANTRINE
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This drug has been approved in Nigeria as follows:
Identifier | Form | Presentation | Description | Approval |
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B4-7667 | Tablet | MALETHER PLUS 20/120 TABLETS TAB 20 mg; 120 mg 1X24 | 31 RNW-PP-280388 MALETHER PLUS 20/120 TABLETS ARTEMETHER 20MG + LUMEFANTRINE 120MG ARTEMETHER 20MG + LUMEFANTRINE 120MG EXCIPIENTS: SILICON DIOXIDE USP 2MG, CROSCARMELLOSE SODIUM USP 2MG, MAGNESIUM STEARATE USP 2MG, MICROCRYSTALLINE CELLULOSE USP 74MG, POLYSORBATE 80 0.3MG, 9% HPMC 75% ETHANOL 7.5MG, CROSCARMELLOUS SODIUM USP 2.2%, SILICON DIOXIDE USP 1.8%, MAGNESIUM STEARATE 2.6%, CARBOXYMETHYL STARCH SODIUM 2.0%, HPMC USP 0.984MG, ETHANOL (95%) BP 29.680MG B4-7667 Drugs Imported Products 1X24 Over The Counter (OTC) 9/20/2022 GENEITH PHARMACEUTICALS LIMITED, ADEWALE CRESCENT, OFF EWENLA STREET, OSHODI ISOLO LAGOS 8122912281 ngouzoamaka@yahoo.com Front Pharmaceuticals Plc, Economic and Technical Development Zone, Xuancheng, Anhui, China., China | 06/07/2023 |
B4-7668 | Tablet | MALETHER PLUS 80/480 TABLETS TAB 80 mg; 480 mg 1 X 6 | 32 RNW-PP-280362 MALETHER PLUS 80/480 TABLETS ARTEMETHER 80MG + LUMEFANTRINE 480MG ARTEMETHER 80MG + LUMEFANTRINE 480MG EXCIPIENTS Q.S B4-7668 Drugs Imported Products 1X6 Over The Counter (OTC) 9/20/2022 GENEITH PHARMACEUTICALS LIMITED, ADEWALE CRESCENT, OFF EWENLA STREET, OSHODI ISOLO LAGOS 8122912281 ngouzoamaka@yahoo.com Front Pharmaceuticals Plc, Economic and Technical Development Zone, Xuancheng, Anhui, China., China | 06/07/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
---|---|---|
P01BF01 | Artemether and lumefantrine | P Antiparasitic products, insecticides and repellents → P01 Antiprotozoals → P01B Antimalarials → P01BF Artemisinin and derivatives, combinations |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
---|---|---|
NG | Registered Drug Product Database | B4-7667, B4-7668 |
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