Ocaliva (obeticholic acid): New contraindication for the treatment of primary biliary cholangitis (PBC) in patients with decompensated liver cirrhosis or a history of prior hepatic decompensation

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This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date.

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Key facts

Medicine name
Ocaliva
Active substance
Obeticholic acid
Therapeutic area (MeSH)
Liver Cirrhosis, Biliary
Procedure number
EMEA/H/C/004093/II/0030
Regulatory outcome
Variation
DHPC type
New contraindication
Human ATC code
A05AA04
Dissemination date
09/06/2022

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