Regulatory PathRegulatory requirements compared

Active substances

Atovaquone + Proguanil

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MALARONE250,100 mg,mgFilm-coated tablet · Oral use12 BlisterSAR 124.05NCE · PrescriptionGLAXOWELLCOMEValid
MALAUST250,100 mg,mgFilm-coated tablet · Oral use12 BlisterSAR 44.25Generic · PrescriptionGlenmark Pharmaceuticals LimitedValid
Indications — CHI Daman Drug Formulary

MALARIA-PREVENTION AND CHEMOPROPHYLAXIS; RENAL TRANSPLANT

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

ProductStrengthForm · routeApplicantStatusFirst approved
MALARONE250MG;100MGtablet · oralGLAXOSMITHKLINEPrescription14 Jul 2000
MALARONE PEDIATRIC62.5MG;25MGtablet · oralGLAXOSMITHKLINEPrescription14 Jul 2000
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE250MG;100MG; 62.5MG;25MGtablet · oralGLENMARK PHARMS LTDPrescription12 Jan 2011
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE62.5MG;25MG; 250MG;100MGtablet · oralMYLANPrescription27 May 2014

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS02466783250 MG; 100 MGTABLET · ORALGLENMARK PHARMACEUTICALS CANADA INC.
ATOVAQUONE PROGUANIL02421429100 MG; 250 MGTABLET · ORALSANIS HEALTH INC
MALARONE02238151250 MG; 100 MGTABLET · ORALGLAXOSMITHKLINE INC
MALARONE PEDIATRIC0226493562.5 MG; 25.0 MGTABLET · ORALGLAXOSMITHKLINE INC
MYLAN-ATOVAQUONE/PROGUANIL02402165100 MG; 250 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
TEVA-ATOVAQUONE PROGUANIL02380927250 MG; 100 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACATOVAQUONE-PROGUANIL 250-100 MG TABLET$1.48584per EA23 Sep 2026
US NADACATOVAQUONE-PROGUANIL 62.5-25$0.92749per EA23 Sep 2026
NHS Drug TariffProguanil 100mg / Atovaquone 250mg tablets£25.2112 tablet1 Oct 2026
NHS Drug TariffProguanil 25mg / Atovaquone 62.5mg tablets£6.2612 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.

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), 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.