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
|