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)
| Brand | DIN | Strength | Form · route | Company |
| POMBILITI | 02556898 | 105 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | AMICUS 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.