Regulatory PathRegulatory requirements compared

Active substance

Digoxin immune fab

Open in the medicines table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
DIGIFAB0236104340 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSBTG INTERNATIONAL INC

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
DIGIFAB, 40MG/VIAL DIGOXIN IMMUNE FAB, POWDER FOR SOLUTION FOR INFUSIONPL 21744/0001PROTHERICS UK 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.