Regulatory PathRegulatory requirements compared

Active substance

Pentamidine isetionate

Open in the medicines table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PENTAMIDINE ISETIONATE FOR INJECTION BP02183080300 MG / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSPFIZER CANADA ULC
PENTAMIDINE ISETIONATE FOR INJECTION BP02517663300 MG / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSMARCAN PHARMACEUTICALS INC

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
PENTACARINAT 300MG POWDER FOR SOLUTION FOR INJECTION/INFUSIONPL 52710/0001THE SIMPLE PHARMA COMPANY LIMITEDPOM
PENTAMIDINE ISETIONATE TILLOMED 300 MG POWDER FOR SOLUTION FOR INJECTION/INFUSIONPL 11311/0675TILLOMED LABORATORIES LIMITEDPOM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.