EMA
- Application: EMEA/H/C/005927
- Marketing authorisation holder: Pharming Technologies B.V.
- Local brand name: Joenja
- Indication: Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
- Pathway: orphan
- Status: approved
Joenja (LENIOLISIB) 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.
Pharming Technologies B.V. holds the EU marketing authorisation.