EMA — authorised 12 December 2016
- Marketing authorisation holder: Intercept Pharma Ltd
- Status: approved
🇪🇺 Ocaliva in European Union
EMA authorised Ocaliva on 12 December 2016
Marketing authorisation
Ocaliva in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Ocaliva approved in European Union?
Yes. EMA authorised it on 12 December 2016.
Who is the marketing authorisation holder for Ocaliva in European Union?
Intercept Pharma Ltd holds the EU marketing authorisation.