Regulatory PathRegulatory requirements compared

Active substance

Orforglipron hemicalcium

Open in the medicines table

EMA European Union — centrally authorised medicines

Foundayo Eli Lilly Nederland B.V. · Opinion · ATC A10BJ

Therapeutic indication (EMA)

Treatment of obesity and type 2 diabetes mellitus in adults

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
FOUNDAYO 0.8 MG FILM-COATED TABLETSPL 14895/0369ELI LILLY NEDERLAND B.V.POM
FOUNDAYO 14.5 MG FILM-COATED TABLETSPL 14895/0373ELI LILLY NEDERLAND B.V.POM
FOUNDAYO 17.2 MG FILM-COATED TABLETSPL 14895/0374ELI LILLY NEDERLAND B.V.POM
FOUNDAYO 2.5 MG FILM-COATED TABLETSPL 14895/0370ELI LILLY NEDERLAND B.V.POM
FOUNDAYO 5.5 MG FILM-COATED TABLETSPL 14895/0371ELI LILLY NEDERLAND B.V.POM
FOUNDAYO 9 MG FILM-COATED TABLETSPL 14895/0372ELI LILLY NEDERLAND B.V.POM

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.

Updated