Regulatory PathRegulatory requirements compared

Active substances

Artemether + Lumefantrine

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
COARTEM20MG;120MGtablet · oralNOVARTISPrescription7 Apr 2009

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
RIAMET 20MG/120MG TABLETSPL 23860/0024NOVARTIS IRELAND LIMITEDPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffArtemether 20mg / Lumefantrine 120mg tablets£22.5024 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 6.5.3.1. Antimalarial medicines > Medicines for curative treatment · core
    Malaria due to Plasmodium falciparum; Malaria due to Plasmodium vivax
    Oral > Solid > dispersible tablet: 20 mg + 120 mg (EMLc) | Oral > Solid > tablet: 20 mg + 120 mg

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.