Active substance
Miltefosine
- US FDA 1
- WHO EML 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| IMPAVIDO | 50MG | capsule · oral | KNIGHT THERAPS | Prescription | 19 Mar 2014 |
WHO WHO Model List of Essential Medicines (2025)
- 6.5.2. Antileishmaniasis medicines · core
Visceral leishmaniasis; Cutaneous leishmaniasis; Mucocutaneous leishmaniasis
Oral > Solid: 10 mg; 50 mg
Safety signals and safety-related labeling changes
- US FDA 25 May 2021 IMPAVIDO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.