This brand name is authorized in Nigeria.
The drug COMBISUNATE 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 |
---|---|---|---|---|
A4-5549 | Tablet | Combisunate 20/120 Tablets TAB 20 mg; 120 mg 1 x 24's | Tablet | 31/07/2024 |
A4-5550 | Tablet | COMBISUNATE 40/240 TABLET TAB 40 mg; 240 mg 2X6 | 50 RNW-PP-224034 COMBISUNATE 40/240 TABLET ARTEMETHER/LUMEFANTRINE ARTEMETHER 40MG, LUMEFANTRINE 240MG, MICROCRYSTALLINE CELLULOSE (AVICEL PH 102), CROSPOVIDONE, SODIUM LAURYL SULPHATE (KOLLIPHOR SLS FINE), COLLOIDAL SILICON DIOXIDE (AEROSIL 200 PHARMA) PURIFIED TALC, MAGNESIUM STEARATE A4-5550 Drugs Imported Products 26 Over The Counter (OTC) 9/15/2021 WORLD WIDE COMMERCIAL VENTURES LTD, ILUPEJU INDUSTRIAL ESTATE ILUPEJU LAGOS 14526126 lucky.ubokor@worldwidehealthcare.com AJANTA PHARMA LTD, PLOT NO. B-4/5/6, MIDC, PAITHAN AURANGABAD 431148 MAHARASHTRA STATE, INDIA, India | 07/07/2023 |
A4-5551 | Tablet | COMBISUNATE 80/480 TABLET TAB 80 mg; 480 mg 1x6 | 66 RNW-PP-256910 COMBISUNATE 80/480 TABLET ARTEMETHER 80MG + LUMEFANTRINE 480MG TABLETS ARTEMETHER Ph. Int. 80MG, LUMEFANTRINE 480MG, MICROCRYSTALLINE CELLULOSE(AVICEL PH 102), CROSPOVIDONE, SODIUM LAURYL SULPHATE (KOLLIPHOR SLS FINE), COLLOIDAL SILICON DIOXIDE (AEROSIL 200PHARMA), PURIFIED TALC, MAGNESIUM STEARATE A4-5551 Drugs Imported Products 16 Prescription Only Medicine (POM) 3/24/2022 WORLD WIDE COMMERCIAL VENTURES LTD, ILUPEJU INDUSTRIAL ESTATE ILUPEJU LAGOS 14526126 lucky.ubokor@worldwidehealthcare.com AJANTA PHARMA LTD, PLOT NO. B-4/5/6, MIDC, PAITHAN AURANGABAD 431148 MAHARASHTRA STATE, INDIA, India | 25/05/2023 |
B4-0591 | Dispersible tablet | Combisunate Dispersible 20/120 mg Tablets TAB_ORALLY_DIS 20 mg; 120 mg 1 x 6's; 1 x 12's (in PVC/PVdC-Aluminium blisters) | Dispersible Tablet. Yellow coloured, circular, flat bevelled edge, dispersible tablets | 28/08/2024 |
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 | A4-5549, A4-5550, A4-5551, B4-0591 |
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