EMA — authorised 26 May 2016
- Marketing authorisation holder: Amicus Therapeutics UK Ltd
- Status: approved
🇪🇺 Galafold in European Union
EMA authorised Galafold on 26 May 2016
Marketing authorisation
Galafold 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 Galafold approved in European Union?
Yes. EMA authorised it on 26 May 2016.
Who is the marketing authorisation holder for Galafold in European Union?
Amicus Therapeutics UK Ltd holds the EU marketing authorisation.