EMA decides to withdraw the approval of...

EMA decides to withdraw the approval of…

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medicine

Tuesday, 16 July 2024

Amsterdam The farnesoid-X agonist obeticholic acid, which was provisionally approved as Ocaliva for the treatment of primary biliary cholangitis (PBC) at the end of 2016 due to its favorable effects on biomarkers of liver damage, will probably be withdrawn from the market. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended revoking the approval. The reason is safety risks in use and a…

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