PMDA — authorised 23 March 2018
- Marketing authorisation holder: Amicus Therapeutics Inc
- Status: approved
🇯🇵 Galafold in Japan
PMDA authorised Galafold on 23 March 2018
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 Japan
Frequently asked questions
Is Galafold approved in Japan?
Yes. PMDA authorised it on 23 March 2018.
Who is the marketing authorisation holder for Galafold in Japan?
Amicus Therapeutics Inc holds the Japanese marketing authorisation.