Regulatory PathRegulatory requirements compared

Active substance

Levamisole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
KETRAX SYR 40MG-5ML8 mg/mlSyrup · Oral use1 BottleSAR 5.80NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed
KETRAX TAB 40MG40 mgTablet · Oral use30 BlisterSAR 26.05NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed
KETRAX TAB 40MG40 mgTablet · Oral use3 BlisterSAR 3.30NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
ERGAMISOLEQ 50MG BASEtablet · oralJANSSEN PHARMADiscontinued18 Jun 1990

WHO WHO Model List of Essential Medicines (2025)

  • 6.1.1. Intestinal anthelminthics · core
    Ascariasis
    Oral > Solid > tablet: 50 mg (as hydrochloride); 150 mg (as hydrochloride) (EML)

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.