This brand name is authorized in Nigeria.
The drug IBUMARTEM 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 |
|---|---|---|---|---|
| B4-6458 | Tablet | Ibumartem 80/480 Tablet TAB 80 mg; 480 mg | Tablet IBUMARTEM 80/480 TABLET B4-6458 IBUMARTEM 80/480 TABLET ARTEMETHER 80MG, LUMEFANTRINE 480MG, MAIZE STARCH 120MG, MICROCRYSTALLINE CELLULOSE 83.4MG, METHYL PARABEN 0.9MG, PROPYL PARABEN 0.5MG, MAGNESSIUM STEARATE 9.7MG Over The Counter (OTC) IBU PHARM NIG. LTD, CHURCH STREET,LAGOS LAGOS LAGOS Nigeria LESANTO LABORATORIES., PLOT NO. 9, 10, 11 & 20, SURVEY NO 53, NEAR RLY. BRIDGE, MANOR ROAD PALGHAR (E) DIST THANE, MAHARASHTRA, INDIA., India 26/01/2023 25/01/2028 | 26/01/2023 |
| B4-8593 | Tablet | Ibumartem 20/120 Tablet TAB 20 mg; 120 mg 1 x 24's | Uncoated Tablet. Yellow, round, biconvex uncoated tablet with breakline on one side and plain on the reverse | 27/05/2025 |
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 | B4-6458, B4-8593 |
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