Product Details

ARTEPREF 80/480 TABLETS

Arthemeter; Lumefantrine
80mg; 480mg
Tablet

ROA

Oral

Applicant Name

Preferred Drugs Nigeria Limited

NRN

C4-0093

Status

Active


Composition

"EACH FILM COATED TABLET CONTAINS: ARTEMETHER PH. INT. 80 MG LUMAFANTRINE PH. INT. 480 MG LIST OF EXCIPIENTS 1 MICRO CRYSTALLINE CELLULOSE AS PER BP 2 MAIZE STARCH AS PER BP 3 POLYSORBATE 80 AS PER BP 4 COLLOIDAL ANHYDROUS SILICA AS PER BP 5 MAGNESIUM STEARATE AS PER BP 6 PURIFIED TALC AS PER BP 7 CROSCARMELLOSE SODIUM AS PER BP 8 H.P.M.C. (E-15) AS PER BP 9 MACROGOLS ( PEG-6000) AS PER BP 10 PROPYLENE GLYCOL AS PER BP 11 COLOUR QUINOLINE YELLOW LAKE AS PER IHS 12 ISOPROPYL ALCOHOL AS PER BP 13 METHYLENE DICHLORIDE AS PER B  

ATC Code

P01BF01  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1X6  

Product Description

ARTEPREF 80/480 TABLETS "EACH FILM COATED TABLET CONTAINS: ARTEMETHER PH. INT. 80 MG LUMAFANTRINE PH. INT. 480 MG LIST OF EXCIPIENTS 1 MICRO CRYSTALLINE CELLULOSE AS PER BP 2 MAIZE STARCH AS PER BP 3 POLYSORBATE 80 AS PER BP 4 COLLOIDAL ANHYDROUS SILICA AS PER BP 5 MAGNESIUM STEARATE AS PER BP 6 PURIFIED TALC AS PER BP 7 CROSCARMELLOSE SODIUM AS PER BP 8 H.P.M.C. (E-15) AS PER BP 9 MACROGOLS ( PEG-6000) AS PER BP 10 PROPYLENE GLYCOL AS PER BP 11 COLOUR QUINOLINE YELLOW LAKE AS PER IHS 12 ISOPROPYL ALCOHOL AS PER BP 13 METHYLENE DICHLORIDE AS PER B " C4-0093 Drugs Imported Product 1X6 11-07-2024 PREFERRED DRUGS NIGERIA LIMITED, NO.3, CAUTIONAVENUEOFFOKPANAMROAD, ASABA, DELTA, ASABA, , DELTA +12022278616 preferred.drugs@gmail.com "FREDUN PHARMACEUTICALS LIMITED,, PLOT NO, 14,15,16, ZORABIAN INDUSTRIL COMPLEX, VILLAGE VEOOR, TAL, PALGHAR, THANE 401404 MAHARASHTRA STATE, INDIA. "

Manufacturer Name

ZORIABIAN INDUSTRIL COMPLEX

Manufacturer Country

INDIA  

Approval Date

2025-03-27  

Expiry Date

2030-03-26