EMA
- Application: EMEA/H/C/006579
- Marketing authorisation holder: Arrowhead Pharmaceuticals Ireland Limited
- Local brand name: Redemplo
- Indication: Treatment of familial chylomicronaemia syndrome (FCS).
- Pathway: orphan
- Status: approved
Redemplo (PLOZASIRAN) regulatory status in European Union.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA has authorised it.
Arrowhead Pharmaceuticals Ireland Limited holds the EU marketing authorisation.