Regulatory PathRegulatory requirements compared

Active substance

Cipaglucosidase alfa

Open in the medicines table

EMA European Union — centrally authorised medicines

Pombiliti Amicus Therapeutics Europe Limited · Authorised · authorised 20 Mar 2023 · ATC A16AB

Therapeutic indication (EMA)

Pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset Pompe disease (acid ?-glucosidase [GAA] deficiency).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
POMBILITI02556898105 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSAMICUS THERAPEUTICS CANADA INC.

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.