EMA
- Application: EMEA/H/C/004867
- Marketing authorisation holder: Ipsen Pharma
- Local brand name: Sohonos
- Indication: Treatment of fibrodysplasia ossificans progressiva.
- Pathway: orphan
- Status: rejected
Sohonos (PALOVAROTENE) 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.
Ipsen Pharma holds the EU marketing authorisation.