MALARSHIN

This brand name is authorized in Nigeria.

Active ingredients

The drug MALARSHIN contains a combination of these active pharmaceutical ingredients (APIs):

1	Artemether UNII C7D6T3H22J - ARTEMETHER
	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.
	Read more about Artemether
2	Lumefantrine UNII F38R0JR742 - LUMEFANTRINE
	Read more about Lumefantrine

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-100566	Tablet	Malarshin DS 40/480 mg Tablets TAB 80 mg; 480 mg 10 x 1 x 6's (i blister packs)	Tablet 60 NF-PP-324475 Malarshin DS 40/480mg Tablets Artemether 80mg & Lumefantrine 480mg Artemether - - 80 Lumefantrine - - 480 Microcrystalline cellulose - - 1.10 Lactose - - 0.60 Povidone - - 1.00 Isopropyl Alcohol - - 7.0 Ltr Colloidal Anhydrous Silica - - 0.80 Magnesium Stearate - - 3.00 Croscarmellose Sodium - - 2.00 Crospovidone - - 2.00 Purified Talc - - 1.00 Hydroxypropylmethyl Cellulose - - 0.75 Purified Talc - - 0.20 Polyethylene Glycol - 4000 - - 0.28 Titanium Dioxide - - 0.21 Tartrazine Yellow - - 0.06 Isopropyl Alcohol - - 8.0 Ltr Methylene Chloride A4-100566 Drugs Imported Products 1016 Over The Counter (OTC) 4/25/2023 SHINFIELD PHARMACEUTICALS LIMITED, 80 Luwaleyinmu Street, Ikeja 33572403 chidi.jonathan@shinfield-pharma.com UNIZA LIFECARE PRIVATE LIMITED, SR. NO. 919/7, OLD SR. NO 404, KADI-DETROJ ROAD, BALASAR, TAL: KADI, DIST: MEHSANA, GUJARAT-382715, INDIA., India	31/10/2023
A4-100567	Tablet	Malarshin 20/120 Tablets TAB 20 mg; 120 mg 24 X 30	61 NF-PP-324523 Malarshin 20/120 Tablets Artemether 20mg & Lumefantrine 120mg Artemether In-House Active 20.000 Lumefantrine In-House Active 120.00 Maize Starch BP Disintegrant 87.750 Lactose BP Diluent 35.000 Tartrazine Yellow In-House Colorant 0.250 Povidone BP Binder 10.000 Isopropyl Alcohol BP Solvent Q.S Colloidal Anhydrous Silica BP Disintegrant 5.000 Magnesium Stearate BP Lubricant 10.000 Croscarmellose Sodium BP Disintegrant 10.000 Purified Talc BP Lubricant 2.000 A4-100567 Drugs Imported Products 2430 Over The Counter (OTC) 4/25/2023 SHINFIELD PHARMACEUTICALS LIMITED, 80 Luwaleyinmu Street, Ikeja 33572403 chidi.jonathan@shinfield-pharma.com UNIZA LIFECARE PRIVATE LIMITED, SR. NO. 919/7, OLD SR. NO 404, KADI-DETROJ ROAD, BALASAR, TAL: KADI, DIST: MEHSANA, GUJARAT-382715, INDIA., India	31/10/2023

Medicine classification

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
Discover more medicines within P01BF01

Authorization and marketing

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	A4-100566, A4-100567