Advanz Pharma secures temporary suspension of the European Commission decision on the Ocaliva conditional marketing authorisation in Europe

Advanz Pharma

5 September 2024 - Advanz Pharma today announces that the General Court of the European Union has temporarily suspended the European Commission decision to revoke the conditional marketing authorisation for Ocaliva (obeticholic acid) in Europe (EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway) for second-line treatment of patients with the rare liver disease primary biliary cholangitis.

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Regulation