Regulatory PathRegulatory requirements compared

Active substance

Chlorambucil

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LEUKERAN 2 MG. TAB.2 mgFilm-coated tablet · Oral use25 BlisterSAR 237.60NCE · PrescriptionASPEN PHARMA TRADING LIMITED (APTL)Valid
LEUKERAN 2 MG. TAB2 mgFilm-coated tablet · Oral use25 BlisterSAR 297.00NCE · PrescriptionASPENWithdrawn by MAH · Not Marketed
LEUKERAN 2 MG. TAB.2 mgFilm-coated tablet · Oral use25 Tablet ContainerSAR 25.85NCE · PrescriptionGLAXOWELLCOMEWithdrawn by MAH · Not Marketed
LEUKERAN 5 MG. TAB.5 mgFilm-coated tablet · Oral use25 BlisterSAR 39.45NCE · PrescriptionGLAXOWELLCOMEWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); FOLLICULAR LYMPHOMA; MARGINAL ZONE LYMPHOMA

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

ProductStrengthForm · routeApplicantStatusFirst approved
LEUKERAN2MGtablet · oralWAYLIS THERAPPrescription18 Mar 1957

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
LEUKERAN000046262 MGTABLET · ORALASPEN PHARMACARE CANADA INC.

WHO WHO Model List of Essential Medicines (2025)

  • 8.2.1. Cytotoxic medicines · complementary
    Chronic lymphocytic leukaemia or small lymphocytic lymphoma
    Oral > Solid: 2 mg tablet

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.