Regulatory PathRegulatory requirements compared

Active substances

Mifepristone + Misoprostol

Open in the medicines table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
FEMYSO02560569200 MCG; 200 MGTABLET; KIT · ORAL; BUCCALLUPIN PHARMA CANADA LIMITED
MIFEGYMISO02444038200 MCG; 200 MGKIT; TABLET · BUCCAL; ORALLINEPHARMA INTERNATIONAL LIMITED

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
MEDABON: COMBIPACK OF MIFEPRISTONE 200 MG TABLET AND MISOPROSTOL 4 X 0.2 MG VAGINAL TABLETSPL 31750/0042SUN PHARMACEUTICAL INDUSTRIES EUROPE BVPOM

Components

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.