Regulatory PathRegulatory requirements compared

Active substances

Foscarbidopa + Foslevodopa

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)solution · subcutaneousABBVIEPrescription16 Oct 2024

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
VYALEV02537702240 MG / ML; 12 MG / MLSOLUTION · SUBCUTANEOUSABBVIE CORPORATION

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), 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.