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International Package Leaflet - COARTEM

Drug Regulatory Affairs COARTEM (artemether/lumefantrine) 20 mg/120 mg, 80 mg/480 mg Tablets International Package Leaflet IPL Creator: Mohammed Muneeruddin CDS Author: Eric Randolph, Joseph KappelGLC approval: 13 March 2012 amended 11 October 2012 Release date: 02 Nov 2012 amended 12 Dec 2012 Tracking Number: 2012-PSB/GLC-0582-sDocument status: Final Number of pages: 23 Novartis Page 2 International Package Leaflet 02-Nov-12 amend 12-Dec-12 COARTEM COARTEM Antimalarial, artemisinins and derivatives DESCRIPTION AND COMPOSITION Pharmaceutical form 20 mg/120 mg tablets Yellow, round and flat tablet with beveled edges and score on one side.

Novartis Page 4 International Package Leaflet 02-Nov-12 amend 12-Dec-12 Coartem Treatment and stand-by emergency treatment The treatment should be administered at the time of initial diagnosis or at onset of symptoms.

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