EMA
- Application: EMEA/H/C/005203
- Marketing authorisation holder: Orphazyme A/S
- Local brand name: Miplyffa
- Indication: Treatment of Niemann-Pick disease type C (NPC).
- Pathway: orphan
- Status: withdrawn
🇪🇺 Miplyffa in European Union
Miplyffa (ARIMOCLOMOL) regulatory status in European Union.
Marketing authorisation
Miplyffa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in European Union
Frequently asked questions
Is Miplyffa approved in European Union?
Yes. EMA has authorised it.
Who is the marketing authorisation holder for Miplyffa in European Union?
Orphazyme A/S holds the EU marketing authorisation.