🇪🇺 Sohonos in European Union

Sohonos (PALOVAROTENE) regulatory status in European Union.

Marketing authorisation

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

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Sohonos in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Bone approved in European Union

Frequently asked questions

Is Sohonos approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for Sohonos in European Union?

Ipsen Pharma holds the EU marketing authorisation.