Regulatory PathRegulatory requirements compared

Active substance

Chlormethine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Ledaga 160 micrograms/g gel160 µg/gGel · Topical1 TubeSAR 6183.15NCE · PrescriptionRecordati Rare DiseasesValid

EMA European Union — centrally authorised medicines

Ledaga Helsinn Birex Pharmaceuticals Ltd. · Authorised · authorised 3 Mar 2017 · ATC L01AA05

Therapeutic indication (EMA)

Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
LEDAGA02516764160 MCG / GGEL · TOPICALRECORDATI RARE DISEASES CANADA INC

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.