Regulatory PathRegulatory requirements compared

Active substance

Stibogluconate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PENTOSTAM100 mg/mlSolution for injection · Intravenous use1 VialSAR 453.75NCE · PrescriptionGLAXOWELLCOMEWithdrawn by MAH · Not Marketed
PENTOSTAM100 mg/mlSolution for injection · Intravenous use10 VialSAR 106.90NCE · PrescriptionGLAXOWELLCOMEWithdrawn by MAH · Not Marketed

WHO WHO Model List of Essential Medicines (2025)

  • 6.5.2. Antileishmaniasis medicines · core
    Visceral leishmaniasis; Mucocutaneous leishmaniasis; Cutaneous leishmaniasis
    Parenteral > General injections > unspecified: 100 mg per mL in 30 mL vial

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.