Ocaliva marketing authorisation was finally revoked by the European Medicines Agency (EMA)

The marketing authorisation for Ocaliva was finally revoked by the European Medicines Agencys (EMA) after the EMA had already recommended revoking Ocaliva’s marketing authorization in June 2024. It says the benefits of Ocaliva are no longer considered to outweigh its risks

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For more Information regarding the EMA´s revocation of conditional marketing authorisation for Ocaliva please click here.

In order to better understand the previous steps and the reactions of ERN RARE-LIVER, please read our statement.

Furthermore, the Foord and Drug Administration (FDA) of the United States posted a warning on serious liver injury in Ocaliva treated patients without cirrhosis.

Please click here to read the FDA Drug Safety Communication Update from 12 December 2024 on Ocaliva.