Regulatory PathRegulatory requirements compared

Active substance

Isosorbide 5

Open in the medicines table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-ISMN0227283060 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
PMS-ISMN0230128860 MGTABLET (EXTENDED-RELEASE) · ORALPHARMASCIENCE INC
PRO-ISMN - 600231132160 MGTABLET (EXTENDED-RELEASE) · ORALPRO DOC LIMITEE
PRZ-ISMN0256256160 MGTABLET (EXTENDED-RELEASE) · ORALPHARMARIS CANADA INC

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
CARMIL 20 MG TABLETSPL 16363/0001MILPHARM LIMITEDP
CARMIL 40 MG TABLETSPL 16363/0002MILPHARM LIMITEDP
CARMIL XL TABLETSPL 16363/0003MILPHARM LIMITEDP
CHEMYDUR 60XLPL 20072/0220AMDIPHARM UK LIMITEDP
EUMON 25XLPL 28444/0208ACTIVASE PHARMACEUTICALS LIMITEDP
EUMON 30XLPL 28444/0209ACTIVASE PHARMACEUTICALS LIMITEDP
EUMON 40XLPL 11311/0455TILLOMED LABORATORIES LIMITEDP
EUMON 50XLPL 28444/0210ACTIVASE PHARMACEUTICALS LIMITEDP
EUMON 60 XLPL 11311/0457TILLOMED LABORATORIES LIMITEDP
ISODUR 25XL CAPSULESPL 27827/0021GALEN LIMITEDP
ISODUR 50XL CAPSULESPL 27827/0022GALEN LIMITEDP
ISOSORBIDE MONONITRATE 20 MG TABLETSPL 16363/0001MILPHARM LIMITEDP
ISOSORBIDE MONONITRATE 20MG TABLETSPL 04556/0057PHARMVIT LIMITEDP
ISOSORBIDE MONONITRATE 20MG TABLETSPL 21880/0117MEDREICH PLCP
ISOSORBIDE MONONITRATE 40 MG TABLETSPL 16363/0002MILPHARM LIMITEDP
ISOSORBIDE MONONITRATE 40MG TABLETSPL 21880/0118MEDREICH PLCP
ISOSORBIDE MONONITRATE KENT 40MG XL TABLETSPL 51463/0028KENT PHARMA UK LIMITEDP
ISOTARD 25 MG XL TABLETSPL 44616/0006EVOLAN PHARMA ABP
ISOTARD 40MG XL TABLETSPL 44616/0007EVOLAN PHARMA ABP
ISOTARD 50MG XL TABLETSPL 44616/0008EVOLAN PHARMA ABP
ISOTARD 60MG XL TABLETSPL 44616/0009EVOLAN PHARMA ABP
MEDOMON XL 60MG PROLONGED RELEASE TABLETSPL 49565/0025RUDIPHARM LIMITEDP
MITRATE 60XLPL 20072/0220AMDIPHARM UK LIMITEDP
MODISAL XL 40MG PROLONGED RELEASE TABLETSPL 55612/0014ENNOGEN IP LTDP
MONOMAX XL 60 MG TABLETSPL 08829/0102CHIESI LIMITEDP

7 more — full table

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.