EMA — authorised 20 March 2023
- Marketing authorisation holder: AMICUS THERAPEUTICS EUROPE LIMITED
- Status: approved
🇪🇺 Pombiliti in European Union
EMA authorised Pombiliti on 20 March 2023
Marketing authorisations
EMA — authorised 20 March 2023
- Application: EMEA/H/C/005703
- Marketing authorisation holder: Amicus Therapeutics Europe Limited
- Local brand name: Pombiliti
- Indication: 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).
- Status: approved
Pombiliti in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Pombiliti approved in European Union?
Yes. EMA authorised it on 20 March 2023; EMA authorised it on 20 March 2023.
Who is the marketing authorisation holder for Pombiliti in European Union?
AMICUS THERAPEUTICS EUROPE LIMITED holds the EU marketing authorisation.